Computer System Validation (CSV)

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We can define the validation approach and methodology to be followed, establish document deliverables, specific responsibilities for the departments/personnel, and completion criterion during the lifecycle for the implementation and

maintenance of your computerized systems

• Documenting the intended use of the computerized system(s)

• Assessing the compliance and business risks

• Demonstrating adherence with applicable regulations through objective evidence

• Ensuring the system’s integrity throughout testing

• Establishing operational controls necessary to maintain the systems in a validated state

1. Management structure
2. Method of assuring quality in the product (quality system, responsibility for quality)
3. Use of documented Quality Management System (QMS), e.g., the existence of a quality policy and objectives, quality manual, process definition/procedures, standards
4. Maturity of QMS (relevance to the product under audit)
5. Control of QMS documentation (reviews, approvals, distribution, updates)
6. Maintenance of QMS documentation (regularly reviewed and updated when appropriate)
7. QMS certified to a recognized standard (e.g., ISO9001)
8. Method of checking compliance with QMS (internal audits, management reviews)
9. Qualifications and suitability of staff
10. Staff training (general, product-related, new staff, changes to QMS, regulatory issues, training records)
11. Use of sub-contractors (individuals, companies)

1. Does the Product have defined User Requirements Specifications?
2. Does the Product have defined Functional Specifications?
3. Does the Product have defined Software Design Specifications?
4. Does the Product have defined Hardware Design Specifications?
5. What is the relationship between specifications (together forming a complete specification of the system which can be tested objectively)?
6. Can you establish traceability through specifications (e.g.,   for a given requirement)?
7. What is the status of specifications (reviews, approvals, distribution, maintenance, and updates)?
8. What is the accuracy of and conformance to relevant process definitions/procedures?

1. Is there an explanation of the testing strategy employed at each level of development (e.g., module testing, integration testing, system-level acceptance testing, or alpha/beta testing)?
2. Is there structure and content of each test script (unique reference, unambiguous description of test, acceptance criteria/expected results, cross-reference to controlling specification)?
3. What is the relationship between test specifications and controlling specifications (demonstrating that the system has been thoroughly tested with traceability between specifications and tests)?
4. Is there objective evidence that tests cover:

• Both structural and functional testing;
• All requirements;
• Each function in the system;
• Security;
• Stress testing;
• Performance testing;
• Abnormal conditions.

We are here to help with the validation of software, both Commercial off-the-shelf (COTS) and custom-developed applications that interact with regulated operations or provide data or reports that are reported to regulatory agencies.