Regulatory Guidelines for CSV

Embarking on the path to a successful Computer System Validation (CSV) roadmap begins with a solid understanding of the applicable regulatory requirements within your industry and region.

Investing the time to understand which regulations you must comply with, which are advantageous, and which, are the gold standard, is a crucial starting point for your CSV journey. This knowledge lays the groundwork for your CSV roadmap, helping you pinpoint the specific validation activities essential for compliance.

Now, let’s dive into some key CSV guidance documents specifically catered to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).

GCP Guidance

  • FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations
  • ICH E6(R2) Good Clinical Practice
  • FDA 21 CFR Part 11: Electronic Records; Electronic Signatures

GMP Guidance:

  • FDA Guidance for Industry: Data Integrity and Compliance with Drug CGMP Questions and Answers
  • PIC/S PI 011-3: Good Practices for Computerised Systems in Regulated GxP Environments
  • EU Annex 11: Computerised Systems
  • GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

GLP Guidance

  • OECD 17: Application of GLP Principles to Computerised System
  • OECD 17: Supplement No 1 GLP and Cloud Computing
  • OECD 22: GLP Data Integrity
  • MHRA: Guidance on GxP data integrity

Understanding regulatory requirements is not merely a step in CSV but the foundation that informs your journey.

When determining which systems need validation at this stage, consider the below questions:

  • Are you using the system for regulated processes such as clinical trials, laboratory testing, or manufacturing operations?
  • Does the system process or store data regulated by GxP guidelines?
  • Is the system critical to your product’s or process’ quality or safety?
  • Could the system potentially affect the accuracy, reliability, or integrity of regulated data?
  • Does the computer system interact with other regulated systems, such as laboratory instrumentation or process control?
  • Are you using cloud-based services or remote access to regulated data or systems?

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Resource Person: Joseph Turton

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