Computerized System Validation (CSV) Consulting Services

Service Background

Since the early 20th century, the application of computerized systems in the pharmaceutical industry has been continuously expanding. Countries and regions including the United States, the European Union, Japan, the United Kingdom, and China have successively issued regulatory requirements related to computerized systems. With the deepening of the Pharma 4.0 concept, the informatization construction of pharmaceutical enterprises has been elevated to a new level. On December 1, 2020, China issued the Requirements for Drug Records and Data Management (Trial Implementation), marking that China’s requirements for data integrity have become increasingly stringent. However, due to the professionalism and technical complexity of informatization systems, enterprises still face significant challenges in controlling the compliance of informatization system construction processes.

Pain Points in Computerized System Validation for Pharmaceutical Equipment

In the life sciences industry (including pharmaceuticals and medical devices), compliance requirements are the "lifeline" of enterprises. With the continuous development of information technology, the level of enterprise automation has gradually improved, and more and more computerized systems are being used in production processes. Standards and requirements for Computerized System Validation (CSV) are also constantly updated and becoming more standardized.

How to fully and effectively implement CSV under strict compliance supervision is a problem that all enterprises must solve. With the strengthening of regulatory efforts and the implementation of the updated version of China’s GMP—especially the announcement (No. 54 of 2015) issued by the National Medical Products Administration (NMPA) on the two appendices to the Good Manufacturing Practice (GMP) for Drugs (Revised 2010), namely Computerized Systems and Qualification and Validation—higher requirements have been put forward for the validation of computerized systems in pharmaceutical enterprises. It is clearly stipulated that CSV should run through the entire lifecycle of computerized systems.

Hippocrates’s CSV Consulting Services: Empowering Enterprise Compliance and Digital Transformation

Computerized systems are increasingly widely used in the life sciences industry (such as pharmaceuticals and medical devices), covering production control, quality management, and data recording & analysis. These systems have become core components of enterprise operations. However, as regulatory requirements become more stringent, enterprises must ensure that these systems not only operate efficiently but also meet strict compliance standards.

As a quality compliance expert in the life sciences field, Hippocrates provides Computerized System Validation (CSV) consulting services specifically designed to address this need.

What is Computerized System Validation (CSV)?

Computerized System Validation (CSV) is a comprehensive validation process aimed at ensuring that a computerized system meets its intended performance and specifications while complying with regulatory requirements and quality standards. CSV covers multiple phases, including:

• Validation Plan (VP)
• User Requirements Specification (URS)
• Risk Assessment (RA)
• Design Qualification (DQ)
• Installation/Operational/Performance Qualification (IQ/OQ/PQ)
• Final Validation Report (TRM)

Regulatory/Guideline Background

There is no unified technical standard for the validation of computerized systems in pharmaceutical equipment worldwide. Internationally, the ISPE GAMP 5 (Good Automated Manufacturing Practice – Revision 5) serves as a leading practice guideline for computerized systems in the pharmaceutical industry and has been subtly influencing the computerized system quality management activities of pharmaceutical enterprises globally.

Currently, countries are paying increasing attention to data integrity, and many countries/organizations have released separate appendices on computerized systems. In May 2015, China officially issued the two appendices (Computerized Systems and Qualification and Validation), and on December 1, 2015, higher requirements were imposed on the validation of computerized systems in pharmaceutical enterprises—clearly stating that CSV should run through the entire lifecycle of computerized systems.

When Chinese pharmaceutical enterprises enter the international market, they need to improve their validation capabilities. However, domestic pharmaceutical enterprises have limited access to practical cases for reference in computerized system validation, and their system validation management capabilities remain relatively low. The implementation of CSV varies greatly among some domestic enterprises, with validation often being superficial (e.g., simply concluding that the system is "compliant" to "perfectly" complete CSV).

Therefore, clarifying the processes and methods of computerized system validation and improving validation capabilities as soon as possible are urgent tasks for all life sciences enterprises, including those in the pharmaceutical and medical device sectors.

Relevant regulations/guidelines are listed below:

• FDA 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
• FDA 21 CFR Part 11, Electronic Records; Electronic Signatures
• EudraLex Volume 4, Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
• EudraLex Volume 4, Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use; Annex 11: Computerized Systems
• NMPA Good Manufacturing Practice for Drugs
• NMPA Requirements for Drug Records and Data Management (Trial Implementation)
• NMPA GMP Appendix: Computerized Systems
• MHRA: ‘GXP’ Data Integrity Guidance and Definitions
• ISPE GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems

Scope of Hippocrates’s CSV Services

Hippocrates provides modular and comprehensive CSV services and can customize validation solutions based on clients’ specific needs. The service scope includes (but is not limited to):

• Validation Plan (VP): Define validation objectives, scope, and resource allocation.
• User Requirements Specification (URS): Detail the functional and performance requirements of the system.
• Risk Assessment (RA): Identify potential risks and develop response measures.
• Design Qualification (DQ): Verify whether the system design meets the requirement specifications.
• Installation/Operational/Performance Qualification (IQ/OQ/PQ): Ensure stable and reliable operation of the system in actual use.
• Validation Report (TRM): Summarize the validation process and results, and provide proof of compliance.
  
• In addition, Hippocrates offers validation services for various systems (e.g., QMS, LIMS, ERP, WMS, MES), ensuring that these systems meet both business needs and domestic/international regulatory requirements.

Advantages of Hippocrates’s CSV Services

1. Meeting Domestic and International Regulatory Compliance: Hippocrates ’s CSV services strictly adhere to international standards such as GMP, ICH, FDA, cGMP, EU-GMP, and ISPE GAMP 5, ensuring enterprises comply with regulatory requirements globally.
2. Risk-Based Validation Approach: Hippocrates’s validation management tool (Validation+) adopts a risk-based method, which can effectively shorten project validation time (by an average of 30%-40%) while ensuring sufficient testing for high-risk projects.
3. Flexible Modular Services: Hippocrates’s CSV services can be customized according to enterprises’ specific needs, supporting on-demand deployment during enterprises’ digital transformation.
4. Strong Technical Support and Training: In addition to professional validation services, Hippocrates provides systematic operation training and after-sales consulting services to ensure enterprises maintain long-term compliance.

Application Scenarios

Hippocrates’s CSV consulting services are widely applied in the life sciences industry (including pharmaceuticals, medical devices, and food), especially in the following scenarios:

• New System Launch: Ensure the new system complies with regulatory requirements before it is put into use.
• System Upgrade or Modification: Validate the compliance of the system after upgrades or modifications.
• Legacy System Transformation: Evaluate and transform existing computerized systems to meet regulatory requirements.

Team Background

Team members hold qualifications such as PMP (Project Management Professional) certification (U.S.-based) and IBM/CPM certifications. They ensure that testing management services throughout the product lifecycle are guided by GxP and GAMP 5 best practices. Through CSV validation, they guarantee the stable and reliable operation of systems, compliance with regulatory requirements, and thus the improvement of product quality and safety.