Articles tagged with “data-integrity”

Analyze the 2026 surge in FDA warning letters for contract manufacturers. Review data integrity risks, regulatory updates, and supply chain oversight strategies

Analyze FDA Project Elsa, a generative AI system that prioritizes facility inspections by detecting risk patterns in adverse events and regulatory data.

Explore AI automation for Clinical Study Reports (CSRs). Analyze efficiency gains, regulatory compliance, and risks like hallucinations and data security.

Analyze GxP compliance risks of ChatGPT vs. Microsoft Copilot in Veeva. Learn governance strategies for data integrity and AI system validation.

Learn deviation management in Veeva Vault QMS. Compare digital workflows to paper/Excel, covering root cause analysis, CAPA linkage, and 21 CFR 11 compliance.

An in-depth review of inventory software meeting 21 CFR Part 11 FDA rules. Explore key requirements like electronic signatures, audit trails, and ALCOA+ princip

Examine the risks of DIY quality systems in biotech. Learn about FDA Part 11 compliance, data integrity, and when to transition from Excel to eQMS software.

Examine evidence for open-source software in GxP environments. Learn how validation strategies enable compliance while eliminating proprietary vendor lock-in.

Learn 21 CFR Part 11 requirements for electronic records. This guide analyzes cost-effective FDA compliance strategies for small biotechnology startups.

Review the ISPE GAMP AI Guide for validating machine learning in GxP. Learn the risk-based framework for data integrity and regulatory compliance.

Explore AI governance frameworks for pharmaceutical companies. Learn to align AI with GxP, FDA regulations, and data integrity standards for safe adoption.

Explore GxP requirements for Electronic Batch Records (EBR) in biotech. Covers FDA 21 CFR Part 11 compliance, validation, and current software options.

A guide to applying ALCOA+ data integrity standards to AI and machine learning. Covers FDA compliance, data governance, and validation for regulated sectors.

Explore FDA 21 CFR Part 11 compliance for electronic records and signatures. Learn about validation, audit trails, and data integrity enforcement trends.

Explore GxP audit trail requirements for AI systems. Review 21 CFR Part 11, Annex 11, and ALCOA+ rules for logging training data, prompts, and model outputs.

Explore GxP compliance requirements for ChatGPT and Copilot. Learn about 21 CFR Part 11, system validation, and data integrity strategies for regulated AI.

Explore FDA 21 CFR Part 11 compliance for AI systems. This guide covers validation, audit trails, and data integrity for machine learning in GxP environments.

Learn AI/ML validation in GxP using GAMP 5 2nd Ed. and FDA CSA. Explains risk-based lifecycles, data integrity, and compliance for adaptive models.

Choosing a GxP ELN? Compare Benchling, IDBS, and LabArchives on features for 21 CFR Part 11 compliance, system validation, and ALCOA data integrity principles.

Learn how MES and Electronic Batch Records (EBR) improve pharma manufacturing. This guide explains benefits for GMP compliance, data integrity, and review-by-ex

Learn to validate AI/ML systems in GxP manufacturing using the GAMP 5 Appendix D11 framework. Explore key considerations for data integrity, risk, and model dri

Navigate FDA 21 CFR Part 11 for AI systems. This article details compliance strategies for validation, audit trails, and data integrity in regulated GxP setting

Learn to apply the GAMP 5 risk-based approach for AI/ML validation in GxP environments. This guide covers data integrity, model drift, and regulatory compliance

Learn best practices for eDiary data collection in clinical trials. This guide covers design, implementation, and regulatory compliance for high-quality PRO dat

Learn why Structured Product Labeling (SPL) is replacing PDF for pharma labeling. This guide explains the FDA mandate, XML standards, and how SPL ensures data i

Learn about the database lock process in clinical trials. This guide covers its importance for data integrity, the steps involved, and key team responsibilities

Learn the complete query management process in clinical trials. This guide covers the workflow, high costs, and impact on data integrity for CROs and sites.

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

A detailed guide to the 13 principles of Good Clinical Practice (GCP). Understand the ICH E6(R2) standards for protecting subjects and ensuring data integrity.

A complete guide to clinical trial site close-out. Our checklist covers data integrity, IP accountability, archiving, and regulatory compliance per ICH-GCP & FD

Learn the technical requirements for GLP audit trails. This guide covers compliant file systems, immutable storage (WORM), and network shares for data integrity

Learn about 21 CFR Part 58, the FDA's Good Laboratory Practice (GLP) regulations for nonclinical studies. This guide covers its scope, history, and key subparts

A technical guide to creating a GLP-compliant audit trail on macOS. Learn to meet data integrity rules (21 CFR Part 11) using APFS, FSEvents & Endpoint Security

Explore how AI impacts Good Documentation Practice (GDocP) and ALCOA+ principles in life sciences. Learn about efficiency gains, data integrity risks, and new r

An in-depth analysis of pharmaceutical compliance software for GxP and QMS. Learn key features for 21 CFR Part 11 and compare top vendors like Veeva & MasterCon

Learn the 9 ALCOA+ principles for GxP data integrity. This complete guide explains each attribute, FDA & EMA regulations, and compliance for pharma and life sci

Explore a risk-based framework for validating generative AI in GxP systems. Learn how to meet 21 CFR Part 11 rules, ensure data integrity, and apply CSA princip

An in-depth analysis of the 2025 Computer System Validation (CSV) job market. Learn about validation specialist salaries, key skills, and career trends.

A comprehensive guide to lab equipment qualification (IQ/OQ/PQ). Learn the process, regulatory standards including FDA's finalized CSA guidance, and how AI-powered automation streamlines validation and compliance.

Learn the key differences between GAMP 4 and GAMP 5. Updated for 2026 with FDA's finalized CSA guidance, ISPE GAMP AI Guide, and EU GMP Annex 11/22 drafts. Clear migration path for pharma IT.

Updated 2026 guide for IT on 21 CFR Part 11. Covers FDA CSA guidance, AI compliance, electronic records & signatures, system validation, audit trails & data integrity

Learn the key updates in ISPE GAMP 5 Second Edition. Updated for 2026 with FDA's finalized CSA guidance, ISPE GAMP AI Guide, and EU Annex 11/22 revisions

This article explains the core functions of LIMS for sample management, data integrity, and regulatory compliance, and provides a comparative analysis of top systems.

This article defines open-source LIMS and details its core functions, such as sample registration, data collection, quality control, and workflow management. Updated for 2026 with SENAITE 2.6.0, LabKey 25.11, OpenELIS AI features, FDA CSA guidance, and current market data.

An explanation of Clinical Data Management (CDM) and its function in research. Learn how CDM ensures high-quality, reliable data for clinical trials.

Learn how WORM (Write Once, Read Many) storage ensures data immutability and integrity for electronic records in the highly regulated biotechnology industry. Updated for 2026 with the latest on EU GMP Annex 11 revisions, SEC 17a-4 audit-trail alternatives, cloud WORM advances, and ransomware defense strategies.

An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies, data integrity measures, and the latest 2025-2026 regulatory developments including the Annex 11 draft revision and FDA CSA guidance.

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance (including finalized CSA and AI credibility framework), and controls for data integrity and audit-ready systems. Updated February 2026.

Explore US pharmaceutical automation compliance, covering FDA regulations like cGMP & 21 CFR Part 11, Pharma 4.0 trends, challenges, and best practices.

This article details AI's role in biotech sample management, covering traditional workflows, challenges, AI innovations, regulatory issues, and future outlook.

Learn about the 2025 job market for Computer System Validation (CSV) professionals. Understand CSV's critical role in regulated industries for data integrity and patient safety.

Learn about regulatory compliance software in pharmaceuticals, covering GMP, GLP, GCP, FDA 21 CFR Part 11, and EU Annex 11 standards for data integrity.

Compare GAMP 4 and GAMP 5. Learn key differences in their approaches to system validation, risk management, system classification, and integration of modern technologies. Updated with 2025 FDA CSA guidance and ISPE GAMP AI Guide.

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications. Updated for 2025-2026 with FDA CSA guidance, EU Annex 11 revision, and ISPE AI Guide.

Learn what Computer System Validation (CSV) is, its crucial role in pharmaceutical and biotech compliance, ensuring data integrity and regulatory adherence for patient safety.

A comprehensive guide to regulatory requirements and best practices for implementing compliant Randomization and Trial Supply Management (RTSM) systems in clinical trials, covering FDA, EMA, and global standards.