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Evolution of a companywide validation program

¹American Cyanamid Company, Princeton, NJ 08543-0400, USA.

Quality Assurance (San Diego, Calif.)

|December 1, 1995

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Establishing a robust computer validation program requires comprehensive policies and procedures. A structured, step-by-step approach ensures consistent, long-term validation of computerized systems.

Area of Science:

Computer Science
Regulatory Compliance
Quality Management

Background:

Computerized systems are integral to modern operations, necessitating rigorous validation.
An unstructured approach to validation is insufficient for sustained, consistent activities.
Developing a strong computer validation program requires a deliberate, foundational strategy.

Purpose of the Study:

To outline the essential components of a successful computer validation program.
To emphasize the importance of policies, guidelines, and procedures in validation.
To describe a structured methodology for building and maintaining computer validation.

Main Methods:

Establishing a companywide policy and appointing a dedicated administrator.
Forming a computer validation committee for departmental leadership and guideline development.

Related Experiment Videos

Creating system inventories, classifying, and prioritizing systems for validation.

Developing departmental standard operating procedures for routine validation activities.

Implementing quality assurance procedures for oversight throughout the validation process.

Main Results:

A structured, step-by-step approach, though not rigidly ordered, ensures all necessary components are addressed.
A companywide policy, committee oversight, and departmental SOPs are critical for consistency.
System inventories and prioritization are key to managing validation efforts effectively.
Quality assurance involvement is vital for the overall integrity of the validation process.

Conclusions:

A successful computer validation program is built upon a foundation of clear policies, guidelines, and procedures.
Ongoing, consistent computer validation requires a structured, evolving program, not an ad-hoc approach.
Key elements include companywide policy, a dedicated committee, departmental SOPs, and quality assurance oversight.