Validation documents
for computerized systems

In a demanding regulatory context, validation is an essential activity for regulated industries to ensure the reliability, integrity, and security of computerized systems. At the core of this process, validation documents play a key role by providing structure and traceability for validation activities at each stage of the system lifecycle. To better understand the challenges involved, you can consult our article on “Validation of Computerized Systems and Its Key Considerations.” This article explores the main documents required to comply with current good practice guidelines, highlighting their definition, purpose, and content. Note: The term “document” here does not imply paper format. All validation documentation can be in electronic format using various management tools.

Validation Plan (VP)

The Validation Plan (VP) is the initial document that organizes the validation of a specific computerized system. It defines the scope of validation, methodology, planned activities, roles and responsibilities, expected deliverables, system acceptance criteria, and high-level schedule.

This document links validation activities with project activities. It must be clear, precise, and structured to ensure full control over validation activities in accordance with regulatory requirements.

Note: Do not confuse a Validation Plan, which concerns a specific system, with a Master Validation Plan, which organizes the validation of all systems at a site or within a company.

Risk Analysis (RA)

Risk analysis is a core element of validation. It identifies, evaluates, and prioritizes critical elements in the operational context of the regulated company. It relies on methodologies such as GAMP, FMEA, or other approaches.

Risk analysis ensures that validation efforts are proportional to identified risks, especially regarding patient safety, product quality, and data integrity. This document formalizes the analysis and defines the necessary testing activities based on the identified risks.

Content of this document includes:

  • Identification of potential risks (technical, human, organizational) against specifications
  • Assessment / prioritization of risk levels
  • Justification of testing activities according to risk priorities

Traceability Matrix (URS / FS) and Design Review

The traceability matrix links User Requirements Specifications (URS) to Functional Specifications (FS) and associated tests. It is part of the design review, carried out at a minimum for configured or custom computerized systems.

It ensures that all user requirements are properly translated into functional specifications and verified through appropriate tests.

Content of this document includes:

  • List of user requirements (URS)
  • Corresponding functional specifications (FS)
  • References to associated tests and protocols

Test Protocols and Reports (IQ, OQ, DQ, PQ)

Test protocols and reports document the qualification steps: Installation Qualification (IQ), Operational Qualification (OQ), Data Migration Qualification (DQ), and Performance Qualification (PQ).

A test protocol is a formal document detailing testing procedures, responsibilities, and listing all tests to be executed during each qualification step. Various formats are possible, often including test sheets specifying preconditions, step-by-step instructions, and expected results. Test sheets record results, always including a compliance status (pass or fail) and evidence of testing. They formalize system responses for a given environment on a specific day.

If multiple testing campaigns are conducted (e.g., repeating one or more tests after a deviation), all must be documented and referenced.

The test report summarizes the test results from the validation of a computerized system. It provides an overview of testing activities, identified deviations, corrective actions, and conclusions on system compliance.

Validation Report (VR)

The Validation Report (VR) is the final document summarizing all activities carried out during the validation process. It provides evidence that the system meets predefined requirements and is ready for use. Sometimes, it is accompanied by a certificate authorizing the production deployment of the validated system.

Content of this document includes:

  • Summary of tests performed
  • Evaluation of results
  • Management of deviations
  • Conclusion on system compliance

References / Official Guides to Ensure System Reliability

To carry out compliant validation, it is essential to refer to regulatory texts and internationally recognized guides and standards. Key references include:

  • FDA 21 CFR Part 11: FDA regulation on the use of electronic records and signatures
  • EU GMP Annex 11: European recommendations for computerized system management
  • GAMP 5 (Good Automated Manufacturing Practice): ISPE guide providing a structured approach to computerized system validation
  • ISO TR 80002-2: Guide for computerized system validation in the medical device context

Regulatory Compliance Support with Efor

At Efor, we support you at every step of computerized system validation to meet regulatory requirements. Our experts offer:

  • Personalized risk analysis to identify critical activities
  • Creation and implementation of a validation plan tailored to your project and schedule
  • Design and specification reviews with appropriate formality for the system complexity
  • Execution and documentation of tests (IQ, OQ, DQ, PQ) with detailed reports
  • Support for traceability and preparation of final reports
  • Use of your quality management tools or validated Efor templates

Our goal: Ensure your systems are reliable and compliant while facilitating internal and external audits.

Contact us for recognized expertise and tailored support in computerized system validation!

This article has presented the essential documents for computerized system validation. For further information, our team is available to answer your questions and ensure project compliance.