Werum PAS-X MES Consulting & Integration for Pharma Manufacturing
Empowering pharmaceutical and life science organizations with cutting-edge AI solutions.
Services Across the Werum PAS-X Platform
PAS-X MES Implementation
Greenfield and brownfield PAS-X MES rollouts, master batch record authoring, equipment and material master configuration, and operator UI design — for biologics, sterile, oral solid dose, and CGT manufacturing.
SAP & LIMS Integration
PAS-X Connect interfaces to SAP S/4HANA, LabWare, STARLIMS, Thermo SampleManager, AVEVA PI, and DCS via OPC UA. Validated interface specifications, automated regression tests, and ISA-95 alignment.
PAS-X Savvy Analytics
Roll out PAS-X Savvy for self-service batch analytics, statistical process control, deviation root cause analysis, and right-first-time tracking. KPIs designed with QA and MSAT.
PAS-X SaaS Migration
Migrate self-hosted PAS-X to PAS-X SaaS on Microsoft Azure. Re-platform with bounded revalidation, refreshed Part 11 control mapping, and a sustainable upgrade cadence.
AI on Batch Records via MCP
AI agents connected to PAS-X over REST and MCP. Natural-language batch record queries, deviation triage assistance, and review-by-exception copilots — with audit trails and scoped access.
GxP Validation under GAMP 5
Full GAMP 5 Second Edition validation packages for PAS-X core, custom MBRs, interfaces, and AI consumers. Inspection-ready under FDA, EMA, MHRA, and PMDA expectations.
Why Werum PAS-X Dominates Pharma Manufacturing
Werum PAS-X MES is the de facto standard MES across global pharma. It is purpose-built around FDA cGMP, 21 CFR Part 11, and EU GMP Annex 11. Pharma-specific recipe modeling, deep ISA-88 support, and a mature integration story explain its dominance in biologics and sterile manufacturing.
Built for Paperless Manufacturing
The shift from paper batch records to PAS-X eBR is the highest-value digital transformation initiative most pharma manufacturing operations ever run. Industry case studies cite 30 to 70 percent reductions in batch review cycle time and near-elimination of transcription errors. We design the master batch record for review by exception from day one, aligned to ISPE Baseline Guide Volume 7 risk principles, so the structural choices made now scale to AI-assisted batch release later.
Inspection-Ready Out of the Box
PAS-X is familiar territory for every major regulator — FDA, EMA, MHRA, PMDA. We deliver validation under ISPE GAMP 5 Second Edition with explicit data integrity controls aligned to MHRA and FDA guidance. See PAS-X compliance and validation for the full package.
Core Capabilities We Deliver on Werum PAS-X
Process Design & MBR Authoring
To-be process design, recipe modeling under ISA-88, master batch record authoring for biologics, sterile, OSD, and CGT modalities, and review-by-exception design embedded into the MBR structure.
Learn morePAS-X Connect Integration
SAP S/4HANA process orders and material movements, LIMS QC results from LabWare and STARLIMS, AVEVA PI historian streams, DCS/PLC values via OPC UA, and validated interface specifications for each.
Learn morePAS-X SaaS Migration
Re-platform self-hosted PAS-X to PAS-X SaaS on Microsoft Azure with bounded revalidation, refreshed control mapping, and a sustainable Körber release adoption strategy.
Learn moreValidation & Quality
GAMP 5 Second Edition validation packages, IQ/OQ/PQ protocols, traceability matrix, validation summary report, and explicit 21 CFR Part 11 and Annex 11 control mappings ready for inspection.
Learn morePAS-X Savvy Analytics
Self-service batch analytics, statistical process control, deviation root cause analysis, right-first-time tracking, and KPI dashboards for QA, MSAT, and operations leadership.
Learn moreAI on Batch Records
LLM agents connected to PAS-X via REST and Model Context Protocol for natural-language batch record queries, deviation triage assistance, and review-by-exception copilots with audit and scoped access.
Learn moreUse Cases We Build on Werum PAS-X
Biologics eBR Rollout
Master batch record library for mAb upstream and downstream operations, integration to bioreactor DCS, and review-by-exception cycle time reduction tracked in PAS-X Savvy.
Sterile Fill-Finish
Aseptic process eBR with line clearance, environmental monitoring integration, deviation triage workflows, and full Annex 1 alignment for European sites.
Cell & Gene Therapy
Chain-of-identity from apheresis to infusion, autologous batch-of-one recipes, patient-specific labeling, and clinical scheduling integration for CAR-T and similar programs.
OSD Multi-Site Harmonization
Global oral solid dose template with per-site configuration variants, standardized KPIs, and harmonized SAP integration across a dozen plants on a multi-year rollout.
PAS-X SaaS Migration
Greenfield migrations from legacy paper or first-generation MES into PAS-X SaaS on Azure, with bounded revalidation and reduced internal infrastructure ownership.
Review-by-Exception Copilot
AI agent on top of PAS-X that surfaces flagged exceptions, drafts deviation entries from operator notes, and links related batches — with audit trails and scoped access on every action.
Our Engagement Model for PAS-X Programs
PAS-X programs fail for predictable reasons: process design is rushed, integration scope is underestimated, and validation is bolted on at the end. Our engagement model fixes all three. Process design is product-led, integration scope is locked at discovery with PAS-X Connect interface specifications, and validation is embedded from kickoff under GAMP 5 Second Edition. Multi-site rollouts follow the ISPE Pharma 4.0 operating model.
Discovery & Roadmap
Four to six week sprint to inventory current process, integration footprint, validation scope, and AI use cases. Output is a prioritized roadmap with milestones.
Iterative Delivery
Process design, MBR authoring, integration build, and validation run in parallel quarterly slices. Pilot product line goes live before full plant rollout.
Operate & Evolve
Hypercare into managed services: MBR change control, Körber release adoption, AI agent expansion, and ongoing PAS-X Savvy KPI evolution with QA and MSAT.
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Standards, Regulations, and Guidance We Align To
21 CFR Part 11
FDA electronic records and signatures rule. Foundational for PAS-X eBR scope and the bedrock control mapping in our validation packages.
EU GMP Annex 11
European equivalent governing computerized systems in GMP. Required for any PAS-X deployment supporting EU manufacturing or QC programs.
GAMP 5 Second Edition
ISPE risk-based framework for computerized system validation. We deliver PAS-X validation packages aligned to GAMP 5 with category-appropriate rigor per component.
ISA-88 Batch Control
International standard for batch process control. The recipe model in PAS-X follows ISA-88 hierarchy — physical, procedural, and process models cleanly separated.
ISA-95 Enterprise Integration
International standard for ERP-MES-DCS integration. PAS-X Connect interfaces to SAP and DCS are designed around ISA-95 Level 3-4 and Level 2-3 boundaries.
ICH Q10 PQS
ICH pharmaceutical quality system framework. PAS-X-driven deviation, CAPA, and change control workflows align directly to ICH Q10 process performance and product quality monitoring.
ALCOA+ Data Integrity
MHRA, WHO, and PIC/S data integrity principles. We design PAS-X configuration to preserve attribution, contemporaneity, and original record integrity from operator entry through archive.
Annex 1 Sterile Manufacturing
Revised EU GMP Annex 1 for sterile manufacturing in force August 2023. PAS-X eBRs for sterile lines must embed contamination control strategy and aseptic process simulation traceability.
Pharma 4.0
ISPE operating-model framework for digital transformation in pharma manufacturing. PAS-X eBR is the cornerstone of a Pharma 4.0 program.
Frequently Asked Questions
Werum PAS-X MES is the manufacturing execution system from Körber Pharma (the company acquired Werum IT Solutions in 2014) and is widely cited as the global market leader for pharma and biotech MES. According to Körber, PAS-X is used by the majority of the top 30 pharma manufacturers, including most large biologics and sterile fill-finish operators. It is purpose-built around FDA cGMP requirements, 21 CFR Part 11, and EU GMP Annex 11 from the schema up — not generic MES retrofitted with pharma plug-ins. That regulatory pedigree, combined with deep recipe modeling for biologics, sterile, and oral solid dose, is why most large pharma standardize on it.
We support every phase of a PAS-X program: discovery and to-be process design, master batch record (MBR) authoring, equipment and material master configuration, electronic logbook rollout, integration with SAP, LIMS, and process historians, validation under GAMP 5 Second Edition, AI augmentation through PAS-X Savvy and custom Model Context Protocol agents, and post go-live hypercare. We are an AI-first life sciences software firm, so our differentiator is that AI workflows on top of your batch records, deviations, and review-by-exception are built into the program from day one — not bolted on years later.
PAS-X has reference implementations across the full pharma manufacturing portfolio. Körber Pharma publishes solution accelerators for biologics (mAb, vaccines, cell and gene therapy), sterile fill-finish, oral solid dose, semi-solids, APIs, and clinical manufacturing. The recipe model handles continuous, batch, and hybrid processes and is aligned to ISA-88 batch control hierarchy and ISA-95 enterprise integration levels. We typically cut implementation time by reusing Körber accelerators where they fit and only authoring custom MBR logic for genuinely site-specific operations.
PAS-X ships PAS-X Connect as the integration layer for SAP S/4HANA and ECC, LIMS platforms (LabWare, STARLIMS, Thermo SampleManager), DCS/PLC via OPC UA, and process historians like AVEVA PI System (formerly OSIsoft PI). The patterns are well established: SAP releases process orders to PAS-X, PAS-X executes the recipe and consumes materials, LIMS posts QC results back, and the historian streams in-process measurements that PAS-X captures into the EBR. We treat each interface as a validated GAMP 5 object with explicit interface specifications and automated regression tests.
PAS-X MES is the core manufacturing execution system that runs the electronic batch record. PAS-X Savvy is the data analytics and AI layer — a self-service tool for QA, manufacturing science and technology (MSAT), and operations to explore batch data, perform statistical process control, and run AI-assisted root cause analysis on deviations. PAS-X SaaS is the cloud-hosted edition delivered on Microsoft Azure with a multi-tenant operating model, validated infrastructure, and faster upgrades. Most newer programs we run target PAS-X SaaS rather than self-hosted to compress validation effort and reduce internal infra ownership.
PAS-X is designed to support the technical controls required by 21 CFR Part 11 — secure user authentication, fine-grained role-based access, full audit trails on every record, electronic signatures with manifest and meaning, and immutable batch record archives. But Part 11 compliance is always a shared responsibility. Körber delivers the platform, you must validate your specific configuration and prove your processes use the controls correctly. We deliver a full GAMP 5 Second Edition validation package — URS, FS/CS, IQ/OQ/PQ, traceability matrix, and validation summary report — and an explicit Part 11 control mapping. See our PAS-X compliance and validation page for the full approach.
The four enterprise pharma MES platforms most often shortlisted are Werum PAS-X, Siemens Opcenter Execution Pharma (formerly Camstar), Rockwell PharmaSuite, and Emerson Syncade. PAS-X tends to win when biologics, vaccines, and sterile fill-finish are central, when global multi-site harmonization is required, and when out-of-the-box pharma modules outweigh integration with a specific automation supplier. Opcenter often wins where the customer is already deeply Siemens-automated; PharmaSuite where Rockwell DCS dominates; Syncade where Emerson DeltaV is the plant standard. We help customers run an evidence-based selection rather than defaulting to whoever the OT vendor pre-integrates with.
A first-site greenfield PAS-X program for a single product family typically runs 12 to 18 months from kickoff to validated go-live, including process design, MBR authoring, integration build, IQ/OQ/PQ, and operator training. Multi-site rollouts following a global template typically follow at 6 to 9 months per additional site once the template is locked. SaaS deployments can shave several months off infrastructure setup. We always slice work so a pilot product line goes live before the full plant — both to de-risk the validation and to ground the operating model in real shop-floor feedback before it scales.
Global rollouts are the dominant pattern in PAS-X programs. We follow a template-and-tailor model: a global core MBR library, equipment master, and integration patterns owned by a central CoE; per-site configuration variants for local equipment, packaging, and language. Each site rolls out one product line at a time, validation effort is bounded by local extension scope, and harmonization KPIs (batch cycle time, deviation rate, right-first-time) are tracked in PAS-X Savvy. This pattern has been documented by ISPE in ISPE Baseline Guide Volume 7 and is broadly accepted by inspectors.
Paperless manufacturing — sometimes called electronic batch records or eBR — replaces the paper batch record with a structured, auditable digital record produced by PAS-X as the operator executes the recipe. Benefits documented in industry case studies include 30 to 70 percent reduction in batch review cycle time, near-elimination of GMP transcription errors, and faster deviation closure. The shift is also a prerequisite for review-by-exception, where QA only reviews flagged anomalies rather than every batch line, and for AI-assisted batch release. We design the eBR with review-by-exception in mind from day one rather than retrofitting it later, because the data structure decisions made during MBR authoring largely determine how much exception-based review is achievable.
Cell and gene therapy manufacturing has unique MES requirements: chain-of-identity from donor to patient, autologous batch sizes of one, complex scheduling around patient infusion windows, and regulatory expectations under FDA CBER guidance for cell and gene therapy. Körber publishes a CGT-specific PAS-X solution with chain-of-identity tracking, patient-specific recipe instances, and integration to apheresis, fill-finish, and clinical scheduling systems. We have implementation experience for autologous and allogeneic CGT operations and bring proven patterns for the unusual master data and label management challenges these therapies create.
PAS-X Savvy is the analytics and AI tool that consumes PAS-X execution data plus historian and LIMS data to deliver self-service exploration, statistical process control, and AI-assisted deviation analysis. Beyond Savvy, we connect Large Language Model agents to PAS-X using its REST APIs and the Model Context Protocol so QA and MSAT teams can query batch records, deviations, and equipment history in natural language with full audit and scoped access. See our PAS-X AI Integration page for our full AI-on-MES blueprint.
Most engagements begin with a four to six week discovery sprint. We interview manufacturing, QA, MSAT, validation, and IT stakeholders, inventory current paper or legacy MES processes, identify SAP and LIMS interface scope, and produce a prioritized roadmap with cost ranges, milestones, and validation scope. From there we move into to-be process design, MBR authoring, integration build, validation execution, and go-live hypercare. Book a working session through our book a meeting page or browse our integrations index for adjacent platforms we connect.
Because PAS-X is the dominant pharma MES, virtually every major regulator — FDA, EMA, MHRA, PMDA, TGA, NMPA — has inspected PAS-X-based manufacturing operations. The platform itself is familiar territory; what inspectors examine is your validation evidence, your data integrity controls aligned to MHRA data integrity guidance and FDA Data Integrity guidance, and your change control discipline. We design the validation package and operational governance to anticipate inspector questions rather than react to them.
PAS-X is on a regular release cadence with both major versions and incremental patch releases. Customers running self-hosted PAS-X have historically deferred upgrades for years to avoid revalidation cost — at the price of accumulating technical debt and missing AI features only available in newer versions. PAS-X SaaS changes that economics by amortizing upgrade validation across the customer base. We define a release adoption strategy on day one — what gets validated automatically, what triggers regression testing, what triggers full revalidation — so upgrades become routine rather than projects. This aligns with the ISPE Pharma 4.0 operating-model principles for living systems.
Ready to Modernize Your Pharma Manufacturing?
From PAS-X MES rollout to SAP and LIMS integration, PAS-X Savvy analytics, and AI on batch records — with full GxP validation under GAMP 5. Let us show you a roadmap tailored to your manufacturing footprint.
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