Computer System Validation (CSV)

Applying GAMP 5 for Risk-Based Computer System Validation in Pharma

Applying GAMP 5 for Risk-Based Computer System Validation in Pharma Applying GAMP 5 for Risk-Based Computer System Validation in Pharma Computer System Validation (CSV) is an essential requirement in the pharmaceutical industry to ensure that systems impacting product quality, safety,…

Ensuring ALCOA+ and Audit Trail Compliance in CSV

Ensuring ALCOA+ and Audit Trail Compliance in CSV Ensuring ALCOA+ and Audit Trail Compliance in CSV In the pharmaceutical industry, data integrity is the backbone of trust, product quality, and regulatory compliance. Regulatory agencies such as the FDA, EMA, MHRA,…

Validating Electronic Records and Signatures in Pharma Systems

Validating Electronic Records and Signatures in Pharma Systems Validating Electronic Records and Signatures in Pharma Systems Electronic Records (ER) and Electronic Signatures (ES) play a central role in modern pharmaceutical quality systems. From batch releases and lab results to training…

CSV for Cloud-Based Systems: GxP Risks, Controls & Testing

CSV for Cloud-Based Systems: GxP Risks, Controls & Testing Cloud-Based CSV in Pharma: Managing GxP Risks, Controls & Testing As pharmaceutical companies shift from on-premise solutions to cloud-based platforms for LIMS, QMS, Document Management, and Manufacturing Execution Systems (MES), regulatory…

GAMP 5 Explained: A Practical Guide for Pharma CSV

GAMP 5 Explained: A Practical Guide for Pharma CSV GAMP 5 Explained: A Practical Guide for Pharma CSV In the complex landscape of pharmaceutical manufacturing, ensuring the reliability and compliance of computer systems is paramount. The GAMP 5 guidelines offer…

Risk-Based Computer System Validation: Step-by-Step Process

Risk-Based Computer System Validation: Step-by-Step Process Risk-Based Computer System Validation: Step-by-Step Process In the pharmaceutical industry, the validation of computer systems is essential to ensure data integrity, compliance with regulatory requirements, and the safety and efficacy of products. The implementation…

How to Classify Systems Using GAMP 5 Categories

How to Classify Systems Using GAMP 5 Categories How to Classify Systems Using GAMP 5 Categories Step 1: Understanding GAMP 5 Framework The GAMP 5 framework lays the foundation for effective computer system validation (CSV) in the pharmaceutical industry. It…

GAMP 5 vs GAMP 4: Key Differences for Validation Teams

GAMP 5 vs GAMP 4: Key Differences for Validation Teams GAMP 5 vs GAMP 4: Key Differences for Validation Teams The validation lifecycle in pharmaceutical and biologics manufacturing is critical to ensuring compliance with regulatory expectations such as FDA Process…