Articles tagged with “data-integrity”

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, and how automation streamlines validation and complian

Learn the key differences between GAMP 4 and GAMP 5. This guide for pharma IT covers the shift to risk-based validation and provides a clear migration path.

A detailed guide for IT on 21 CFR Part 11. Learn the FDA's rules for electronic records & signatures, including system validation, audit trails, & data integrit

Learn the key updates in ISPE GAMP 5 Second Edition. Our guide covers the new focus on critical thinking, agile validation, cloud services, and CSA for GxP syst

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.

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.

An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies and data integrity measures.

Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance, and controls for data integrity and audit-ready systems.

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.

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications.

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.