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Mastering Computer System Validation Rules Across Borders

Feb 15, 2025

In the tightly regulated world of pharmaceuticals, biotech, and medical devices, ensuring your computer systems meet global standards is a must for keeping operations safe and compliant. At Valina Services, we know how tricky it can be to navigate these rules across different countries. This blog breaks down the essentials of Computerized System Validation (CSV) worldwide, with a special focus on the Asia-Pacific (APAC) region, to help you stay on track with confidence.
Worldwide CSV Standards
Every region has its own rules to ensure computer systems are reliable, secure, and effective for healthcare:
U.S. FDA Requirements
The U.S. Food and Drug Administration (FDA) sets high standards with:

  1. 21 CFR Part 11: Ensures electronic records and signatures are trustworthy and protected.
  2. 21 CFR Part 820: Mandates validation for software used in medical device manufacturing.
  3. 21 CFR Part 211: Requires validated systems for pharmaceutical quality assurance.
The FDA also offers guidance, like the 2002 General Principles of Software Validation and the 2022 Computer Software Assurance (CSA), which emphasizes a risk-based approach to focus validation efforts where they count most.
European Union Guidelines
The EU enforces strict rules through:
  1. EudraLex Volume 4, Annex 11: Sets standards for computer systems in Good Manufacturing Practice (GMP) environments.
  2. EudraLex Volume 4, Chapter 4: Covers electronic documentation system requirements.
  3. EU Medical Device Regulation (MDR): Outlines validation needs for medical device software.
Global Harmonization
The International Council for Harmonisation (ICH) helps align standards globally with:
  1. ICH Q7: GMP rules for active pharmaceutical ingredients.
  2. ICH Q9: Risk-focused quality management strategies.
  3. ICH Q10: Framework for pharmaceutical quality systems.
The ISPE GAMP 5 guide, used worldwide, provides a practical, risk-based way to build compliant systems.
APAC Region: A Mix of Global and Local Rules
The Asia-Pacific region blends international standards with unique local requirements, making CSV both a challenge and an opportunity. Most countries follow global guidelines but add their own specifics.
Shared Standards in APAC
Many APAC nations rely on:
  1. ICH guidelines (Q7, Q9, Q10)
  2. WHOs 2016 TRS 996, Annex 5 for data and record management
  3. ISPE GAMP 5 framework
Country-Specific Requirements in APAC
Japan: The Pharmaceuticals and Medical Devices Agency (PMDA) enforces Japanese GMP (Ministerial Ordinance No. 179), ER/ES Guidelines (similar to 21 CFR Part 11), and 2022 CSV updates.
China: The National Medical Products Administration (NMPA) follows 2010 Chinese GMP, Good Supply Practice (GSP) for distribution, and 2018 Data Integrity Guidelines.
India: The Central Drugs Standard Control Organization (CDSCO) oversees Schedule M of the Drugs and Cosmetics Act, 2018 GMP Guidance, and 2020 Data Integrity rules.
Australia: The Therapeutic Goods Administration (TGA) aligns with PIC/S GMP (including Annex 11) and 2019 Data Integrity Guidance.
Singapore: The Health Sciences Authority (HSA) requires PIC/S GMP compliance and 2021 Data Integrity Guidelines.
South Korea: The Ministry of Food and Drug Safety (MFDS) enforces Korean GMP (aligned with PIC/S) and 2021 CSV Guidelines.
Indonesia: The National Agency of Drug and Food Control (BPOM) follows BPOM GMP Guidelines (aligned with PIC/S) and 2021 Data Integrity Guidance.
PIC/S Impact in APAC
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a major role in APAC, with member countries like Australia (TGA), Japan (PMDA), South Korea (MFDS), Singapore (HSA), Indonesia (BPOM), Malaysia (NPRA), and Thailand (Thai FDA). These nations follow PIC/S Annex 11, which mirrors EU GMP rules for computer systems.
Tips for CSV Success in APAC
To handle CSV across APAC markets, consider these key points:
  1. Common Ground: ICH guidelines and GAMP 5 provide a solid starting point for most APAC countries.
  2. PIC/S Alignment: Many APAC nations follow PIC/S Annex 11 standards.
  3. Local Variations: Each country may have unique rules or interpretations to watch for.
  4. Data Priority: Data integrity and electronic record validation are critical across APAC.
At Valina Services, we guide businesses through these intricate regulations with tailored validation plans that keep compliance practical and efficient. Our deep knowledge of global and regional standards ensures your systems work smoothly across borders.
Ready to streamline your CSV approach? Reach out to Valina Services today to explore how we can support your compliance goals in APAC and beyond.

This blog provides general insights and isnt regulatory advice. Regulations can shift, so always consult qualified experts for your specific compliance needs.

Posted on February 15, 2025 | By Atika Mahfoudi