Navigating CSV Regulatory Requirements Globally and in APAC

Feb 15, 2025

Understanding computerized system validation requirements across borders

In todays highly regulated healthcare industries, ensuring compliance with computerized system validation (CSV) requirements is essential for pharmaceutical, biotechnology, and medical device companies. At Valina Services, we understand that navigating these regulations can be challenging, especially when operating across multiple regions. This guide provides an overview of global CSV regulatory frameworks with special attention to requirements in the APAC region.

Global Regulatory Landscape for CSV

Regulatory bodies worldwide have established comprehensive frameworks to ensure the validity, integrity, and reliability of computerized systems in healthcare industries:

U.S. FDA Regulations & Guidance

The U.S. Food and Drug Administration sets stringent requirements through several key regulations:

• 21 CFR Part 11 – Establishing standards for electronic records and signatures
• 21 CFR Part 820 – Requiring validation of software in medical device production (Section 820.70(i))
• 21 CFR Part 211 – Mandating control and validation of systems affecting pharmaceutical quality (Section 211.68)

The FDA has further clarified these requirements through guidance documents such as the General Principles of Software Validation (2002) and the more recent Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software (2022), which promotes risk-based validation approaches.

European Union Frameworks

The EU maintains equally robust standards through:

• EudraLex Volume 4, Annex 11 – Comprehensive guidelines for computerized systems in GMP environments
• EudraLex Volume 4, Chapter 4 – Requirements for validated electronic documentation systems
• EU Medical Device Regulation (MDR) – Validation requirements for software in medical devices and manufacturing

International Harmonization

Global consistency is supported by the International Council for Harmonisation (ICH) through:

• ICH Q7 – GMP guidelines for active pharmaceutical ingredients
• ICH Q9 – Risk-based approaches to quality management
• ICH Q10 – Pharmaceutical quality system framework

The industry-standard ISPE GAMP 5 provides a risk-based approach to implementing compliant computerized systems and has been widely adopted across the pharmaceutical and medical device sectors.

APAC Region: Regulatory Landscape and Country-Specific Requirements

The Asia-Pacific region presents unique challenges and opportunities for CSV compliance. While most countries align with international standards, each has specific local requirements worth understanding.

Widely Adopted International Standards in APAC

Most APAC nations follow established international guidelines from:

• ICH (Q7, Q9, Q10)
• WHO TRS 996, Annex 5 (2016) on good data and record management
• ISPE GAMP 5 framework

Country-Specific Regulations in APAC

Japan

The Pharmaceuticals and Medical Devices Agency (PMDA) enforces:

• Japanese GMP (Ministerial Ordinance No. 179)
• PMDA ER/ES Guidelines (equivalent to FDA 21 CFR Part 11)
• PMDA CSV Guidelines with recent 2022 updates

China

The National Medical Products Administration (NMPA) maintains:

• Chinese GMP (2010 Revision) for computerized system validation
• Good Supply Practice (GSP) Regulations for pharmaceutical distribution
• Data Integrity Guidelines (2018) aligned with global standards

India

Central Drugs Standard Control Organization (CDSCO) oversees:

• Schedule M of the Drugs and Cosmetics Act
• GMP Guidance Document (2018)
• Data Integrity and Compliance Guidelines (2020)

Australia

The Therapeutic Goods Administration (TGA) enforces:

• PIC/S Guide to GMP including Annex 11
• TGA Data Integrity Guidance (2019)

Singapore

The Health Sciences Authority (HSA) requires:

• PIC/S GMP compliance
• Data Integrity Guidelines (2021)

South Korea

The Ministry of Food and Drug Safety (MFDS) mandates:

• Korean GMP (aligned with PIC/S)
• MFDS CSV Guidelines (2021)

Indonesia

The National Agency of Drug and Food Control (BPOM) requires:

• BPOM GMP Guidelines (aligned with PIC/S)
• BPOM Data Integrity Guidance (2021)

The PIC/S Influence in APAC

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has significant influence across APAC, with several countries being full members:

• Australia (TGA)
• Japan (PMDA)
• South Korea (MFDS)
• Singapore (HSA)
• Indonesia (BPOM)
• Malaysia (NPRA)
• Thailand (Thai FDA)

These member countries follow PIC/S guidelines, particularly Annex 11 on computerized systems, which closely aligns with EU GMP requirements.

Key Considerations for CSV Compliance in APAC

When implementing CSV strategies across APAC markets, consider these essential points:

1. Harmonized Foundation: ICH guidelines and GAMP 5 provide the baseline framework across the region
2. PIC/S Alignment: Many APAC countries follow PIC/S Annex 11 requirements
3. Local Nuances: Each country may have specific additional requirements or interpretations
4. Data Integrity Focus: Across all APAC regulations, data integrity and electronic records validation receive particular emphasis

At Valina Services, we help companies navigate these complex regulatory environments with tailored validation strategies that ensure compliance while maintaining operational efficiency. Our deep understanding of both global and regional requirements enables us to provide practical solutions that work across borders.

Contact us today to learn how we can support your CSV needs across global and APAC markets.

Posted on February 15, 2025 | By Atika Mahfoudi

This blog post is intended for informational purposes only and does not constitute regulatory advice. Regulations may change over time, and companies should consult with qualified regulatory professionals for specific compliance guidance.