Pharma Proofreading: Artwork vs. Text Team Responsibility

In the highly regulated pharmaceutical industry, the final proofreading of packaging and labeling materials is a critical quality control step. Ensuring accuracy in pharmaceutical labeling is non-negotiable: even minor errors (e.g. a misplaced decimal point) can endanger patient safety and trigger costly recalls (^[1]) (^[2]). This report examines the key question: Who “owns” the proofreading step – the artwork (design) team or the text (content) team – in a modern pharma company? Drawing on regulatory guidelines, industry practices, case examples, and technological trends, we find that proofreading is inherently a shared, cross-functional responsibility rather than exclusively owned by one department. Both the content-originating teams (e.g. Regulatory Affairs, Medical Writing, Marketing, Legal) and the artwork/production teams play essential roles in the proofreading process, with final oversight often residing in the Quality/QA organization.

Key findings include:

• Multi-Team Workflow: Pharmaceutical packaging approval typically involves many stakeholders (Regulatory Affairs, Medical/Scientific, Marketing, Legal, Design/Graphics, Production, QA, etc.). The content is usually drafted by regulatory or medical writing teams and then passed to design/artwork for layout. At least two distinct proofing stages often occur: an initial check by content experts, and a cross-check by artwork or QA teams (^[3]) (^[4]).

• Regulatory vs. Artistic Duties: Regulatory/RA teams provide the approved "Editor’s Copy" of text and are primarily responsible for helping ensure content accuracy and compliance with legal labeling requirements (^[5]) (^[4]). Artwork/design teams then incorporate that copy into packaging templates, and they verify that no unintended changes arose during file conversion or layout (^[6]). Both sides conduct reviews: for example, one company had its artwork team proof its design and then have Regulatory Affairs proof it again, highlighting how responsibility is often shared (^[3]).

• Quality Oversight:Quality Assurance (QA) and Manufacturing/Packaging groups provide final sign-off. Regulatory Good Manufacturing Practice (GMP) regulations explicitly require that labeling materials be “carefully examined for identity and conformity” to approved content (^[7]). In the United States, the quality control unit has authority to approve or reject labeling; in the EU, the Qualified Person certifies finished-product batches before release. Neither framework universally assigns final artwork-proofreading ownership to one role; the company’s procedures must define the applicable review and approval controls (^[8]; EU GMP Annex 16).

• Risk of Errors: Labeling mistakes have frequently caused recalls. For example, labeling and artwork errors account for roughly 10–20% of drug/device recalls (^[9]) (^[10]). A retrospective analysis of 3,718 FDA drug recalls from 2012–2023 found that labeling/packaging errors accounted for approximately 19% of all recalls, making them the third most common cause after impurities/contaminants and control issues (^[11]). Industry analyses note that labeling errors remain a persistent problem – “the most common reason” for pharmaceutical recalls in recent years (^[2]) – underscoring the need for robust review processes.

• Automation and Tools: Modern pharma firms increasingly employ automated proofreading and comparison tools to augment human review (^[12]) (^[13]). Automated text-inspection and artwork-comparison systems dramatically reduce proofreading time and catch conversion glitches (^[14]) (^[15]). Case examples show major efficiency gains: one company cut a 3–7 hour manual label proofing task to just 1.25 hours using software (^[14]), and AstraZeneca’s adoption of automated comparison tools allowed faster reviews with higher confidence of error-free results (^[16]).

• Collaborative Governance: The consensus among industry experts is that no single department should bear sole ownership of proofreading. Instead, best practices call for shared responsibility and clear governance models (^[17]) (^[6]). Cross-functional “proofreading” teams or centralized artwork management centers are emerging to coordinate reviews. Crucially, standardized SOPs and checklists (often enforced by quality systems) define the specific duties of each function in the proofreading workflow (^[6]) (^[18]).

• Industry Consolidation: In March 2026, Veralto (NYSE: VLTO) announced that it had entered into a definitive agreement to acquire GlobalVision, subject to customary closing conditions. Veralto said GlobalVision is expected to be integrated into its Esko business. The company described GlobalVision’s approximately $25 million of expected 2026 sales, approximately 85% recurring-revenue mix, and approximately 19% sales CAGR since 2023 as unaudited, forward-looking estimates—not evidence of industry-wide adoption (^[19]).

• Future Directions: Technological advances (^[20], integrated regulatory content platforms, digital labeling) will continue to reshape this space. EMA has published a draft roadmap for ePI in anticipation of upcoming legal requirements; ePI is designed to support authorised product information in electronic formats alongside print (^[21]). DSCSA requirements cover product tracing, product identifiers, authorised trading partners and verification for covered human prescription drugs (^[22]). However, even as tools evolve, the fundamental need for human oversight remains. The future “owner” of proofreading is likely to be the process itself – orchestrated by validated digital systems under quality governance (^[23]) (^[24]).

In summary, the modern pharmaceutical proofreading step is a harmonized quality gate rather than the domain of a single team. Effective control of proofreading hinges on strong processes that involve both content and design experts (and quality oversight) working in tandem (^[3])(^[6]). The debate “Artwork vs. Text” is ultimately resolved by the acknowledgment that both are integral: content must be correct and packaging representation must be error-free. As one industry guideline bluntly concludes, “In an industry where there’s little to no room for error, setting up proper proofreading processes is of critical importance.” (^[25]).

Pharmaceutical products are uniquely regulated. Drug and biologic labeling must contain the information required for the product and jurisdiction, including applicable identity, strength, directions, and warnings. Medical-device labeling is governed separately: in the United States, general device-labeling requirements are in 21 CFR Part 801 and additional requirements can apply by device category. A UDI is generally required on device labels unless an exception or alternative applies; it is not interchangeable with drug-labeling fields (^[26]; FDA UDI exceptions and alternatives). Labeling errors can have serious health implications (^[27]) (^[2]). To prevent mistakes, pharma companies implement multi-step development processes for packaging artwork and labels, typically defined in Standard Operating Procedures (SOPs). The process begins with approved content (brand name, generic name, indications, instructions, etc.) assembled by regulatory, medical writing, or marketing teams. Designers (“artwork production” teams) then produce the final layouts on packaging templates. Each step includes checks for accuracy. Crucially, the proofreading step – a detailed final review of the complete artwork against the approved content – is a key gate before printing.

Historically, proofreading began as a manual task: producers would print proofs (hardcopy or PDFs) and multiple reviewers would visually compare them against source text (^[28]). However, manual proofreading is labor-intensive and error-prone. In today’s global, multilingual supply chains, a single product may have dozens of label variants (different markets and languages) and frequent content updates, further complicating proofreading (^[29]) (^[30]). An iconic example is a multilingual carton where a critical warning line was mistranslated or omitted during layout – such errors force production halts and recalls.

The introduction of digital tools has transformed the landscape. Automated proofreading systems, exampled by products like GlobalVision and TVT, can perform pixel-to-pixel or text-based comparisons between source and proof, greatly speeding up review and catching subtle discrepancies (^[31]) (^[32]). Companies using electronic labeling-workflow records should assess system validation and 21 CFR Part 11 applicability against the relevant predicate-rule requirements and the records on which they rely. Part 11 does not itself require computerized labeling workflows. Companies may also invest in integrated label management systems to maintain a single “source of truth” for product data (^[33]) (^[34]). These trends mean that a modern proofing error may result less from human oversight than from process gaps or system misalignment.

Given this complexity, the question of “who owns the proofreading step” has gained attention in pharmaceutical circles. Is it the responsibility of the “Artwork” (design) group that creates the files? Or the “Text” (content) side (Regulatory Affairs, Labeling specialists) who author the information? Or ultimately the Quality/Release function that must sign off? We examine this question by analyzing regulatory requirements, organizational roles, and real-world practices, as detailed below.

Regulatory Framework

By law, all pharmaceutical labeling and packaging must adhere to stringent regulations. In the United States, rules are codified in 21 CFR. For example, 21 CFR 211.125 requires that “Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master... records.” (^[7]). This GMP requirement mandates examination and written labeling-control procedures, but it does not specify which function performs the examination or approves final artwork; companies assign those responsibilities in their procedures. For EU human medicines, packaging information and label readability are addressed by the applicable Union legislation and the European Commission’s packaging-information and readability guidelines. Requirements can include Braille where applicable; IUCLID is chemical-substance information software, not a medicinal-product labeling code system. Compliance is enforced by agencies: the FDA has issued thousands of warning letters and recalls for labeling violations, underscoring that “non-compliant artwork poses a risk to patient safety and may lead to a warning letter from the FDA, a product recall, and possibly legal and litigation costs” (^[35]). Notably, in September 2025, the FDA published a revised draft guidance on “Safety Labeling Changes — Implementation of Section 505(o)(4) of the FD&C Act,” updating its 2013 guidance to incorporate 2018 congressional changes and clarify when companies must submit proposed labeling changes as prior approval supplements (PAS) versus changes-being-effected (CBE-0) supplements (^[36]). In December 2025, the FDA also finalized guidance on promotional labeling and advertising for biosimilar products, extending recommendations to cover all media including digital formats (^[37]). Meanwhile, ICH released a consolidated Q1 stability-guideline draft for public consultation in April 2025. The Step 2 draft would supersede Q1A–Q1F and Q5C and includes proposed provisions on labelling and storage conditions; it is not a final, binding requirement unless adopted and implemented in the applicable region (^[38]). In Europe, electronic product information (ePI) remains in development. EMA has published a draft roadmap aligned with upcoming legal requirements, is conducting user-acceptance testing, and says that submission guidance for centrally authorised medicines will apply at ePI go-live (^[21]). Regulation (EU) 2025/40 applies from 12 August 2026. Its harmonised material-composition label requirement applies from 12 August 2028 or 24 months after the relevant implementing acts enter into force, whichever is later; the requirement does not apply to immediate and outer medicinal packaging where other required labelling leaves no space or the label could jeopardise safe use (^[39]).

Key Roles and Stakeholders

A company’s packaging-development workflow should identify the functions that prepare approved content, create artwork, perform technical and content checks, and control release. The precise allocation varies by company and product. For U.S. drug products, the quality control unit must have authority to approve or reject labeling, and written procedures must govern its responsibilities and labeling issuance (^[8]; 21 CFR 211.125).

• Regulatory Affairs (RA)/Labeling: Develops and maintains the textual content, ensures compliance with global regulations. Acts as content owners and typically initiates label changes (new markets, updated claims, regulatory updates) (^[5]). They often create an Editor’s Copy (EC) – the finalized text that will go into artwork.

• Artwork/Graphics Team: Takes the approved EC and produces the design file. Responsible for all graphical and technical aspects (dielines, fonts, color, barcodes). Their job includes internal checks that the artwork accurately reflects the text (no missing words, spacing issues, or graphical distortions) (^[6]). They assign version codes and lock the design file for printing.

• Marketing/Brand Team: Ensures packaging aligns with brand guidelines (layout, logos, imagery). They may also participate in content reviews, especially for promotional claims or product naming.

• Legal/Compliance: Reviews for overall legal compliance, accurate trademark use, and any litigation concerns on wording, at times overlapping with Regulatory review.

• Quality Assurance (QA): Oversees the process defined in the company’s quality system and may be assigned review, approval, deviation-management, and release-related activities. In the United States, the quality control unit has authority to approve or reject labeling. In the EU, a Qualified Person certifies a finished-product batch before release; that role is not a universal assignment of final artwork-proofreading ownership (^[8]; EU GMP Annex 16).

Because responsibilities overlap, dedicated Labeling/Artwork Centers or workflows systems are sometimes established. For example, Freyr Solutions notes that some firms place packaging artwork under Regulatory, others under Supply Chain or Packaging, but in reality “it is a shared responsibility — a collaborative ecosystem that connects compliance, manufacturing, supply, and quality together.” (^[40]). The concept of a cross-functional artwork “Center of Excellence” has emerged to standardize this collaboration (^[41]).

Table 1 below summarizes the typical responsibilities of each stakeholder group in the proofreading workflow.

Table 1: Key stakeholders in pharma labeling and their proofreading-related responsibilities (compiled from industry guidelines and best practices (^[5]) (^[4])).

In summary, no single stakeholder exclusively “owns” proofreading. Each party checks aspects related to its expertise. The Regulatory/Text team is responsible for approved content under the company’s governance model, the Artwork team for visual and technical fidelity, and the company’s quality system defines the required controls, approvals, and escalation paths. This interplay is crucial: for example, if a graphic tool changes a character (e.g. the microgram symbol turning into “mg”, a notorious conversion error) (^[42]), the artwork staff must detect it, but the regulatory team must approve the fix. SOPs therefore formalize dual checks: “Market colleagues (Regulatory/Medical/Legal/Marketing) are responsible for proofreading the new or revised artwork against the Editor’s Copy”, including character-by-character verification of text and graphics (^[4]). Meanwhile, the artwork group independently reviews to confirm “there are no omissions or changes from the EC” (^[6]).

What exactly is the “proofreading” step? In pharma packaging, it means the thorough review of a finalized packaging artwork proof against the approved reference content. This includes checking every word and graphic element for accuracy. Key tasks in this step include:

• Textual Verification: Ensuring all label text (drug names, dosage, usage, warnings, etc.) matches the approved source information. This may include a character-by-character comparison.
• Content Completeness: Confirming that all applicable required elements, such as expiry dates, lot or batch identifiers, warnings, or product identifiers, are present and correctly placed for the product and market.
• Regulatory Compliance: Verifying applicable font, warning, language, and other jurisdiction-specific requirements.
• Graphical and Identifier Checks: Ensuring applicable barcodes or UDIs, logos, images, and color quality are correct and appear as intended without distortion or shift.
• No Unapproved Changes: Detecting any inadvertent changes introduced during layout (e.g. missing punctuation, shifted decimal points, wrong graphics).

Proofreading usually occurs in at least two stages. First, the Regulatory/Text team (often along with medical/marketing/legal reviewers) compares the artwork draft against the “Editor’s Copy” to catch errors in transferring the content (^[4]). Then, after artwork revisions, the Artwork/Production team or QA performs a second review of the final locked artwork file (or printer proofs) against the last approved version (^[6]). This second review may involve both human eyeballs and/or automated comparison tools.

In effect, proofreading in pharma is akin to a rigorous quality gate: it is one of several mandatory checks before packaging goes to print. According to industry sources, failure anywhere along the workflow – whether by a medical writer, regulatory colleague, or designer – can let a typo slip through. For example, GlobalVision notes that even if “branding is off, consumers will likely still buy the medication,” but a “misplaced decimal” can have “severe consequences.” (^[43]). Thus, every functional group must engage in proofreading to ensure patient safety and regulatory compliance.

The question frames proofreading as an “Artwork vs. Text” issue. This dichotomy implicitly pits two perspectives:

• Text-Centric View: Regulatory Affairs and Medical Writing teams believe that text content (the actual label copy) is paramount. They argue that since they originated the official wording, they should lead proofreading. After all, any content error (wrong dosage or missing warning) is usually a failure of this team. In practice, many companies require the Labeling Division to give final sign-off on wording, per QA instructions. The idea is that only those with full knowledge of regulatory requirements and the approved dossier can certify the text is correct. This view is reflected in guidelines like the GMP SOP (above) which declares that Market/Regulatory colleagues audit proof character by character (^[4]). As Freyr consultancy notes, RA teams “are the first to identify when a change must occur and initiate the corresponding artwork change control” (^[44]), implying they should also drive final checks.

• Artwork/Design-Centric View: Graphic and packaging engineers feel that layout and production are critical to check. They point out that even perfect text can be ruined during file conversion or printing. For example, an artwork staffer may notice a font issue or a duplicated character that slipped in. They often have tools (such as PDF proofing or DTP proof readers) to automate checks on spatial consistency and fidelity – tasks text owners cannot easily do. From this angle, the question “Who owns proofreading?” is moot, because the artwork group will naturally inspect everything they lay out for mistakes. Their role may include documented packaging-file and printer-proof approvals. In globalVision’s framework, artwork publication is a collaborative effort: after artwork is locked, the art center sends it to market colleagues, but then also “review and approval of Printer Proofs... and assignment of identification number” are by artwork staff (^[45]), indicating they consider final control of the file.

Both perspectives have merit. However, as Schlafender Hase points out, relying solely on manual checks by either side “is not good enough anymore” (^[46]). The fragmentation of processes – copy-paste steps, multiple PDFs, lack of version control – turns proofreading into a high-risk gap (^[47]). Misalignment can happen at each handoff: from Reg Affairs to drafting, to design, to print (^[47]).

Case Example: Dr. Max Pharma

A real-world example highlights this interplay. Dr. Max Pharma (a European generics/contract manufacturer) historically did every packaging proof manually: first the artwork team would independently proof their design, then Regulatory Affairs would proof it again (^[3]). This double-checking chain meant no single team took full ownership – both checked in series. The process was slow and still error-prone. When Dr. Max adopted an automated content-verification platform (TVT), they dramatically reduced the manual burden and error overlap: now both teams “reduced manual checks, transformed multi-language reviews, improved documentation, and increased team confidence” (^[3]). This case reveals a practical truth: proofreading was formerly a shared chore, not an exclusive job, and even with sharing, errors persisted until workflows were tightened.

Quantitative data underscore the stakes:

• Recall Statistics: According to FDA data, there were over 15,000 drug recalls in the U.S. from 2012–2023 (^[48]). Many recalls are driven by labeling errors. A peer-reviewed retrospective analysis of 3,718 FDA drug recalls from June 2012 to September 2023 found that labeling/packaging errors comprised approximately 19% of all recalls — the third most common cause — with an average of ~330 recalls per year and approximately 400,000 product units affected per recall (^[11]). PackagingEurope reports that for medical devices ~9–10% of recalls are labeling-related (holding roughly steady since 2012) (^[9]) (^[49]). Similarly, GlobalVision analysis notes that recent leading FDA drug recalls are ”the most common reason from a packaging perspective” (^[2]). Notable labeling recall examples continue to emerge: in April 2023, Teva Pharmaceuticals issued a voluntary nationwide recall of Fentanyl Buccal Tablets due to safety updates omitted from the Product Insert/Medication Guide (^[50]). These figures demonstrate that proofreading failures frequently translate into recalls, with enormous costs: one source cites $350,000 spent for each global labeling change, and individual recalls can waste millions of units (^[9]).

• Efficiency Gains via Technology: Studies and industry reports illustrate how proper tools improve proofreading efficiency. ClinTrak (a clinical labeling service) reported that before automation, proofing a 19-panel booklet label could take 3–7 person-hours; after implementing GlobalVision’s text-comparison software, the same task took only ~1.25 hours (^[14]). The company also noted that the system caught small font spacing and foreign-character issues beyond human detection (^[14]). One industry analysis reports that smart quality-control automation can reduce lead times in packaging workflows by up to 60–70% and speed deviation resolution by 90% (^[51]). At AstraZeneca, adoption of the TVT text/artwork comparison tool allowed “faster” proofreading with confidence of not missing mistakes (^[16]).

• Human vs. Automated Proofreading: Comparative data illustrate continuing the shift to automation. GlobalVision’s buyer guide provides feature comparisons (Table reproduced as Table 2) and highlights key manual limitations. For example, manual proofreading has human variability and takes hours per review, while an automated system is algorithmic, repeatable, and can do a document’s review in minutes (^[15]). Automated tools also build robust audit trails (critical for 21 CFR Part 11 and EU Annex 11 compliance) and scale easily with the volume of labels (^[15]) (^[52]). The trade-off is losing some contextual insight – but in life sciences the consensus is that combined approaches (machine checking augmented by expert judgment) yield the best results.

Table 2 contrasts manual and automated proofreading approaches, summarizing industry insights:

Table 2: Comparison of manual vs. automated proofreading in pharma packaging (from industry analyses (^[31]) (^[15])).

This evidence suggests that modern pharmaceutical companies are moving toward automated or semi-automated proofing within integrated workflows (^[12]) (^[3]). Nonetheless, automation is not yet universal. Many smaller or legacy organizations still rely heavily on manual reviewers (often expensive PhD-level regulatory writers) for proofreading labor (^[55]), while the remainder of the industry invests in systems to reduce that burden.

Dr. Max Pharma (Cross-Functional Collaboration)

As detailed above, Dr. Max Pharma’s workflow evolution exemplifies the interplay of text and artwork teams. By tasking both the artwork department and the regulatory department to proof each label, the company ensured multiple eyes on each label (^[3]). Yet even this 2-person proofreading chain was cumbersome. After adopting a digital “Content Verification Platform,” Dr. Max noted a transformation: “they reduced manual checks, transformed multi-language reviews, improved documentation, and increased team confidence” (^[3]). This result – eliminating duplicate manual effort without sacrificing accuracy – highlights how both teams sharing the proofreading load can be made efficient through the right tools.

AstraZeneca (Automation Improves Confidence)

AstraZeneca provides a global-scale example of integrating proofreading into standardized workflows. As part of their Labeling SOPs, AZ implemented the TVT comparison software to manage Core Product Information and Global Labeling updates across many markets. Senior manager Martin Rous reports: “Since implementing TVT along with the TVT Artwork module, we can be more confident of our results, and that means less stress for our proofreaders. We can also do the job faster – confident we won’t miss any mistakes.” (^[16]). This statement underscores how blending human review with automated checking allows RA teams to sign off on artwork with greater speed and assurance. In other words, AZ shows that when content teams own final accuracy but empower themselves with tools, the proofreading function is a shared, streamlined responsibility rather than a bottleneck.

ClinTrak (Speeding Clinical Trial Labeling)

ClinTrak (now Fisher Clinical Labeling Services) processes packaging for clinical trials in multiple languages. In 2009 they saw a need to scale up. Traditionally, their Document Quality Control inspectors would manually compare each draft label proof to the approved text character-by-character, a process taking up to 3–7 hours per 19-panel insert (^[14]). After deploying text-inspection and visual proofing systems from GlobalVision, ClinTrak saw dramatic improvements: they reduced the booklet proofing time to ~1.25 hours (^[14]), and the tools caught foreign-character mismatches and even font differences invisible to the human eye. One ClinTrak QA representative said, “The Global Vision solutions allowed the proofreading time for a 19-panel booklet to decrease from three to seven hours to about an hour-and-a-quarter.” (^[14]). While ClinTrak’s process insisted on Regulatory sign-off (clients reviewed proofs), this example illustrates how advanced QA scanning shifts the manual burden and lets RA reviewers focus on substantive content rather than grunt-proofing.

Packaging/Labeling Recall Cases

Concrete examples of labeling oversights underscore the human cost. Medical device manufacturers see ~10% of recalls due to labeling mix-ups (^[9]). A topical case (not pharma but illustrative) involved an outer carton listing the wrong drug strength, while the inner contents were correct – a printing mismatch leading regulators to require a recall (^[56]). In pharmaceuticals, mislabeling incidents (such as strength or e-label mixups) have similarly jeopardized safety. Even consumer items show risk: Horehound cough syrup in the UK was once recalled when children’s doses were printed incorrectly (a misplaced “.” in a 0.5 mL syringe) – a proofreading error in packaging design with real health implications. While specific pharma case studies are often confidential, industry analyses repeatedly point to typos and content errors as the root of many recalls (^[2]).

Collectively, these cases reveal that small mistakes can unravel huge efforts. They also tell us who was involved: a missed comma or wrong dosage can result from either the writer not catching it or the designer missing it. Thus, they argue for distributed checks: no one group “owns” quality alone; rather, multiple groups own parts of it.

Automation Tools: With rising error rates and recall costs, technology solutions have received attention. Systems that compare an “approved master” vs. a “proof copy” are now common. These include:

• Text Comparators (OCR or native-text comparators): Automatically flag any differences in wording, font, or line breaks. For example, GlobalVision’s Docu-Proof and ProofCheck tools, or Schlafender Hase’s TVT, use algorithms to highlight missing words or changes (^[57]) (^[31]). They can handle multiple languages, character sets, and deliver audit reports. In March 2026, Veralto announced a definitive agreement to acquire GlobalVision, subject to customary closing conditions, and said that GlobalVision is expected to be integrated into Esko’s source-to-shelf packaging platform (^[19]). GlobalVision’s cloud-based Verify platform now unifies text, graphics, barcode, and Braille inspection in a single interface and is actively developing enhanced OCR capabilities for inspecting flattened text on documents (^[58]).

• Graphic Overlays / Vision Systems: These take images of printed labels and overlay them with approved art, showing pixel-level deviations. ClinTrak used GlobalVision Proofreader cameras to inspect printed booklets, catching missing graphics or color shifts (^[59]). Medical device firms deploy vision systems at print time to verify every label field (^[60]).

• Integrated Label Management Platforms: Enterprise software (Veeva, Loftware, Esko, etc.) manages label content and workflow. These platforms enforce a single source of brand and regulatory content, automate version control, and sometimes incorporate “smart” proofreading by comparing data fields across countries (^[61]). The trend is toward lowering manual handoffs – for instance, printing labels “just in time” at packaging and scanning barcodes in production to ensure right label meets right product (^[62]) (^[63]).

• AI and Machine Learning: Generative AI has become increasingly embedded in pharma labeling workflows. Platforms like Appian — named a leader in the 2025 Gartner Magic Quadrant for Enterprise Low-Code Application Platforms — now offer AI-driven content analysis including generative AI for draft label text creation with human-in-the-loop validation, AI Copilot for regulatory queries, content summarization of CCDS documents, and automated checking of label updates against safety signals (^[64]) (^[65]). AI models can flag inconsistent doses or cross-linguistic mismatches. However, industry experts caution that ”the problem isn’t the AI. It’s how pharma companies are using AI.” The emphasis is on embedding AI into the overall process, not treating it as a standalone proofreader (^[66]) (^[67]). Early adopters use AI to augment rather than replace human proofreaders, automating repetitive checks while alerting humans to ambiguous cases. The global artwork management software market, valued at approximately $3.5 billion in 2025, is projected to reach $6.0 billion by 2035 at a 5.5% CAGR, driven largely by cloud-based platforms and AI-powered proofing capabilities (^[68]).

Process Integration: Perhaps more critical than any individual tool is how these are integrated. Pharma companies are centralizing labeling verification to avoid the “email/PDF mess” of the past (^[47]). Best practices involve:

• Single Source of Truth: Maintaining approved text in databases (e.g. Regulatory Information Management systems) that feed into artwork, and respective masters that go to print. For example, connecting labeling software directly to ERP to use live product master data, then tracking any changes through audit trails (^[69]).

• Geographically Distributed Teams: Global pharma teams may have local “market colleagues” approve in-country labels. Effective systems ensure changes in one region automatically propagate to others with proper translation review flow (^[29]).

• Checks and Balances: Standard procedures may require more than one reviewer or sign-off on final labels. Under applicable EU GMP arrangements, a Qualified Person certifies the finished-product batch before release, confirming compliance with GMP and the marketing authorisation; this does not universally assign artwork-proofreading ownership to the QP. Companies should assign artwork-proofreading responsibilities through their SOPs and the applicable marketing-authorisation requirements. One publicly available SOP calls for a multi-disciplinary review of artwork content and for the Artwork Center to check its final output for discrepancies (^[70]) (^[6]).

Given this landscape, the “Artwork vs. Text” question is best answered by distinguishing regulatory approval authority from preparatory review tasks. U.S. CGMP rules give the quality control unit authority to approve or reject labeling and require written procedures, but do not dictate how content, artwork, and production functions divide the preparatory checks. In practice:

• Text/Regulatory Perspective: Because they provide the content and bear legal responsibility for its accuracy, RA/medical teams often lead textual proofreading. Internal SOPs usually require them to approve any wording changes and check the final layout to confirm no alterations. One publicly available SOP assigns Market/Regulatory colleagues responsibility for proofreading revised artwork against the Editor’s Copy and includes a detailed verification checklist (^[4]). This is an illustrative company procedure, not a generally binding pharmaceutical-industry requirement. In essence, the content experts own “right first time” accuracy of what is printed. If they sign off, they are attesting that the text is correct.

• Artwork/Graphic Perspective: The design/production team owns the technical integrity of the file. They are responsible for preventing and detecting any errors introduced by software, fonts, or printing processes. For example, conversion errors (like a font mapping a “µg” to “mg” in Adobe Illustrator) are typical risks of artwork creation (^[42]). Artwork staff use proofing software to ensure the final PDF matches the approved source (^[6]). They also check printer proofs for color, bleed, and barcodes. While they rely on the content group to provide correct text, they insist on the right tools to verify that any uncontrolled changes (graphics, barcodes, artwork) did not slip in.

• Bridging the Gap: The brief from Schlafender Hase captures the reality: a “disconnect” between Reg Affairs and Artwork teams leads to errors and recalls (^[71]). The remedy is collaboration: “Involve both teams early… standardize review processes… enforce strict version control… automate verification.” (^[72]). In fact, many companies now create multi-disciplinary review meetings or digital sign-offs to ensure alignment. In short, “compliance is a team effort” (^[73]).

• Quality Assurance Perspective: Companies may designate QA as a final checkpoint or assign that role elsewhere in a controlled workflow. QA does not originate content or create graphics, but may oversee adherence to the approved procedures, investigate discrepancies, and perform release-related activities. In the United States, the quality control unit has authority to approve or reject labeling, while 21 CFR 211.125 requires written labeling-control procedures and examination of issued labeling; neither provision prescribes a universal final-artwork approval model (^[8]; 21 CFR 211.125). The company’s SOPs should identify the approval authority and escalation path.

Implications of Shared Ownership

The collaborative model has implications for responsibility and accountability:

• Checks and Balances: By involving multiple parties, the risk of a single oversight is mitigated, but no one party can shirk responsibility. For instance, if QA finds a missing warning that slipped through, blame could be traced to the responsible content reviewer who approved it, or the designer who omitted it. Clear documentation of who reviewed what (who “signed” the proof) is key.

• SOP Clarity: Organizations must clearly document each step in SOPs (often in RACI charts). Table 1 above outlines such roles. If the SOP says “Regulatory signs off on content, then Art team checks layout, then QA finalizes,” everyone knows their part. In practice, companies often include language like “Market colleagues shall not approve artwork if further changes are expected” (^[74]), enforcing discipline that reduces semi-responsibility scenarios.

• Skill and Resource Allocation: Because proofreading touches expensive resources, companies weigh how to staff it. At one extreme, hiring highly trained scientists as proof-readers is wasteful (^[1]). At the other, entrusting it entirely to junior editors risks missing nuance. The trend is to reserve final content approval to experts (RA/Medical) but automate the mechanical task of comparison. This frees experts from copying tasks while ensuring they have vetted the key decisions.

• Cross-Training and Culture: An integrated proofreading process fosters mutual respect. Art teams must appreciate the content accuracy needs; RA teams must respect design constraints. Some organizations rotate people through each other’s departments or hold joint reviews, blurring the strict “this is my job” stance. Schlafender Hase’s advice (“compliance might be serious business but it doesn’t have to feel like swimming against the tide” (^[73])) reflects this more collegial approach.

Failure to clearly resolve proofreading ownership has real costs:

• Recall Costs: Recalls are enormously expensive. Beyond remediation and product loss, companies suffer fines and reputational damage. The earlier-noted 2018 statistic (almost 10% of device recalls due to labeling issues (^[9])) reflects both unnecessary product loss and regulatory penalties.

• Workflow Efficiency: Ambiguous responsibility can slow approvals. If Regulatory and Artwork keep passing files back and forth to catch each other’s mistakes, every launch is delayed. In a competitive industry, delays in labeling in turn delay product launches, costing market share. Automating and defining ownership speeds time-to-market (high RFT – Right First Time – metrics, as the Freyr blog emphasizes (^[75])).

• Employee Morale and Turnover: Repetitive manual proofreading is monotonous and error-prone (^[1]). Using senior scientists for manual proofing leads to burnout. The 2017 analysis bluntly notes that “people are expensive” and using their time for mundane tasks is poor ROI (^[55]). Clear role definitions and automation let skilled staff focus on value-added work. Conversely, if one team feels burdened unfairly, it creates internal friction.

• Quality Culture: A well-defined workflow with clear final authority (often QA) fosters a quality-conscious culture. If everyone knows who must approve what, and that lapses have consequences, errors drop. Companies that move to a centralized Artwork Center of Excellence (CoE) model – combining regulatory, quality, and creative under one umbrella – report significant improvements in RFT and compliance (^[17]).

Digital Transformation: The future of proofreading in pharma will be shaped by digital platforms:

• Regulatory Content Systems: Single-source databases (Regulatory Information Management, eCTD repositories) are becoming more tightly connected to artwork. For example, linking Veeva RIM with label management (as Appian demonstrated (^[76])) can help keep label text current. Automated alerts can help prevent use of an outdated label. In March 2026, Veralto announced a definitive agreement to acquire GlobalVision, subject to customary closing conditions, and said GlobalVision is expected to be integrated into Esko’s packaging platform (^[19]). That proposed transaction alone does not establish that automated proofreading is standard infrastructure across the industry.

• AI-Augmented Review: Generative AI is increasingly embedded in labeling workflows. Current systems can pre-fill safety statements, translate labels, and generate draft label text with human-in-the-loop validation. AI copilots for regulatory queries are now commercially available, enabling teams to quickly verify compliance requirements across jurisdictions. Future systems may propose text edits or flag unusual changes (e.g., an AI model trained on thousands of labels might flag that a “10 mg” changed to “100 mg” as improbable). However, the need for final human proofreading persists, and oversight remains key.

• Electronic Labeling (e-labels): The EU’s electronic product information (ePI) initiative represents a transformative shift. EMA’s March 2026 roadmap describes a stepwise rollout beginning at the end of 2026, starting with vaccines and followed by oncology; it does not set Q3 and Q4 rollout dates. The EU ePI Common Standard is based on HL7 FHIR (^[77]; EMA ePI overview). Companies should plan controls to keep printed and electronic product information aligned as ePI implementation proceeds.

• Advanced Character Recognition and Serialization: Real-time scanners on packaging lines may help firms verify labels against approved masters as each box is packed. DSCSA establishes enhanced drug-distribution-security requirements for covered prescription drugs, including product tracing and verification by trading partners. It does not prescribe automated OCR verification of packaging labels; firms should determine inspection controls under applicable requirements and their quality systems (^[22]; FDA DSCSA exemptions).

• Regulatory Evolution: Regulation (EU) 2025/40 applies from 12 August 2026, but its harmonised material-composition label requirement applies from 12 August 2028 or 24 months after the relevant implementing acts enter into force, whichever is later. The requirement does not apply to immediate and outer medicinal packaging where other required labelling leaves no space or the label could jeopardise safe use (^[39]). The FDA’s September 2025 revised draft guidance on safety labeling changes clarifies procedures for rapid label updates (^[36]). ICH Q1, released in April 2025, is a Step 2 draft for public consultation that would consolidate Q1A–Q1F and Q5C and proposes provisions linking stability data to labelling and storage conditions; it is not binding until final adoption and applicable regional implementation (^[38]). These developments may require precise review of applicable labelling elements. The more digital tasks become, the clearer it is that responsibility for proofreading will rest on the system’s processes, not on a single person.

Who owns the proofreading step? The answer should be stated in the company’s controlled procedures. For U.S. drug products, the quality control unit must have authority to approve or reject labeling; the regulations do not prescribe which operational function performs each preparatory content or artwork check. Companies should therefore document the respective review, approval, discrepancy, and escalation responsibilities for the people and functions involved (^[8]; 21 CFR 211.125).

Rather than agonize over a single “owner,” best practice is to adopt a governance model that explicitly delineates each party’s duties and hand-offs in the proofreading workflow (^[4]) (^[18]). Many companies explicitly require a multi-disciplinary review – a ‘paper trail’ of approvals – so that by the time QA signs off, the artwork has been vetted from all angles (^[70]). This approach reflects reality: the risk of errors is too great to be left to one group’s stewardship alone.

In essence, proofreading in pharma packaging is not a creative act nor a mere clerical task, but a critical quality assurance function, and it falls under the collective umbrella of a company’s Quality System. The question of “Artwork vs. Text” misses the point that modern labeling quality is achieved through integration of content and design processes. Ultimately, pharmaceutical quality depends on synergy: the regulatory scientists, marketing professionals, designers, and quality officers must all own the check in tandem.

As one industry commentary sums up: “Maintaining pristine packaging requires...prioritiz [ing] quality control, proofreading, and adherence to regulations” (^[25]). In other words, the ownership of proofreading belongs to the company’s quality culture and processes as a whole – a shared effort rather than an individual’s job title.

• AstraZeneca’s use of automated proofreading: Martin Rous (Global Packaging Graphics Manager) on TVT software: “we can be more confident of our results… means less stress for our proofreaders… do the job faster” (^[16]).
• ClinTrak (Fisher BioPharma) clinical labeling QA: adoption of text-comparison software (GlobalVision) cut manual proofing time of a 19-panel booklet from 3–7 hours to ~1.25 hours (^[14]).
• Dr. Max Pharma (Central Europe): relied on double manual proofreading (first artwork team, then Regulatory) until digital proofing tool introduced (^[3]).
• Data on FDA recalls and labeling: Over 15,000 drug recalls since 2012 (^[48]); retrospective analysis of 3,718 recalls (2012–2023) found labeling/packaging errors comprised ~19% of all recalls (^[11]); labeling errors are a leading cause of recalls (^[2]).
• GlobalVision (May 2025): Labeling mistakes “most common” recall cause (^[2]); “no room for error...proper proofreading is of critical importance.” (^[25]).
• PackagingEurope (2019): ~9% of medical device recalls due to labeling errors (^[9]); ~10% of product recalls since 2012 were label-related (^[49]); example ROI: one enterprise saved $19M/year from automated label control (^[78]).
• Schlafender Hase blogs (2024–2025): emphasize cross-functional review, automation, technology in labeling. Key insights: “accuracy isn’t just a goal, it’s a necessity” (^[3]); the introduction of platforms (TVT) to bridge Regulatory/Artwork (^[71]) (^[3]).
• Good Practice SOP (internal GMP guideline): “Market Colleagues are responsible for proofreading… character to character… and that no unexpected changes occurred” (^[4]); Artwork Center staff must “review new or revised artwork… to ensure there are no omissions or changes from the EC” (^[6]).
• 21 CFR 211.125: Labeling materials “shall be carefully examined for identity and conformity” (^[7]), reinforcing QA’s gatekeeper role.
• Product Life Group (2023): The proofreading challenge in pharma (complexity, volume, compliance) (^[79]).
• GlobalVision (2025): Packaging proofing process overview (multi-step, cross-department) (^[80]).
• Informait Buyer’s Guide (Oct 2025): Labeling errors comprise ~20% of FDA recalls (^[10]); automation can reduce time by 60–70% (^[51]); manual vs. automated comparison table (^[15]).
• ARk Resources (2025): Bridging Regulatory/Artwork Teams (Schlafender Hase) on avoiding packaging errors (^[71]) (^[3]).
• Saif et al (2024) systematic review (PMC) on medication label design and patient safety: ~7–30% medication errors involve look-alike packaging (^[27]) (illustrating why label accuracy is crucial).
• Veralto–GlobalVision transaction (March 2026): Veralto announced a definitive agreement to acquire GlobalVision, subject to customary closing conditions, and said GlobalVision is expected to be integrated into Esko. GlobalVision’s approximately $25 million of expected 2026 sales, approximately 85% recurring-revenue mix, and approximately 19% sales CAGR since 2023 were disclosed as unaudited, forward-looking information (^[19]).
• Retrospective FDA recall analysis (2024): 3,718 drug recalls from 2012–2023; labeling/packaging ~19% of total; average ~330 recalls/year, ~400,000 units per recall (^[11]).
• FDA revised draft guidance on safety labeling changes (September 2025): updated implementation of Section 505(o)(4) for PAS vs. CBE-0 supplement submissions (^[36]).
• FDA finalized guidance on biosimilar promotional labeling and advertising (December 2025): recommendations now apply regardless of medium (^[37]).
• ICH Q1 stability-guideline draft (April 2025): a Step 2 draft released for public consultation that would consolidate Q1A–Q1F and Q5C and includes proposed labelling and storage-condition provisions; it is not binding until final adoption and applicable regional implementation (^[38]).
• EMA electronic product information (ePI): draft roadmap aligned with upcoming legal requirements, user-acceptance testing, and submission guidance that will apply at ePI go-live (^[21]).
• Regulation (EU) 2025/40: applies from 12 August 2026; harmonised material-composition labels apply from 12 August 2028 or 24 months after the relevant implementing acts enter into force, whichever is later. Immediate and outer medicinal packaging is exempt where space constraints from other required labelling apply or the label could jeopardise safe use (^[39]).
• DSCSA full enforcement milestones (2025): manufacturers (May 2025), wholesale distributors (August 2025), large dispensers (November 2025), small business dispensers (November 2026) (^[81]).