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CSV in 2026: Computer System Validation for GMP Compliance

Computer system validation in pharma helps companies protect electronic records, control GxP risks, and maintain compliance throughout the validation lifecycle. This guide explains risk-based testing, audit trail review, access control, change control, and inspection-ready evidence.
  • Blog, Validation and Qualification
Pharmaceutical quality specialist reviewing a GxP dashboard for computer system validation in pharma, including audit trail review, access control, testing, and change control.

ConcertAI Expands CancerLinQ; Trust in Clinical AI Now Depends on Validation

ConcertAI has expanded its CancerLinQ platform beyond quality reporting into an AI-powered clinical decision support system that integrates trial matching, structured data extraction, and real-time oncology insights. The announcement highlights a broader industry shift: as AI becomes part of clinical
  • News
ConcertAI Expands CancerLinQ; Trust in Clinical AI Now Depends on Validation

FDA Finds Gaps in Genzyme’s Data Integrity Program; Warning Letter Cites Discarded Review Records

The FDA has issued a warning letter to Sanofi’s Genzyme manufacturing facility in Waterford, Ireland, after identifying significant weaknesses in Data Integrity and quality management during an inspection. The agency found deficiencies in laboratory record reviews, traceability, and deviation handling
  • News
FDA Finds Gaps in Genzyme's Data Integrity Program; Warning Letter Cites Discarded Review Records

EU Annex 11 Explained: Ensuring Data Integrity in Pharmaceuticals

Pharmaceutical firms must prioritize data integrity and robust procedures to meet FDA and EU regulatory expectations. Understanding their detailed guidelines is vital for compliance and data quality. Successfully navigating these regulations requires mastering FDA and EU requirements, including best practices
  • Computerized System Validation, Data Integrity
TrackWise System – General Routine Support

Essential Steps for Conducting Effective Periodic Reviews in CSV

Periodic reviews are conducted throughout the operational life of computerized system to verify that it remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures. The review should confirm
  • Computerized System Validation, Periodic Review
Periodic Review of Computerized system

Enhancing Security through Periodic User Access Reviews

Periodic user access reviews are essential for maintaining the security and integrity of computer systems in the pharmaceutical industry. They play a crucial role in safeguarding sensitive data and ensuring compliance. This blog explores the importance, challenges, and strategies for
  • Computerized System Validation, Periodic Review
Protection of sensitive data

Computer System Validation: Key Strategies for Compliance

Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.
  • Computerized System Validation