Computer Systems Validation

What is Computer Systems Validation?

Computer Systems validation (CSV): the documentary process that assures a computerized system consistently and reliably does exactly what it is designed.

Why is Computer Systems Validation Necessary?

The consistency, reliability and accuracy of data is achieved through proper functioning and performance of the software and computer systems. For this reason, CSV is an integral part of any development and manufacturing practice.

It is also requested in FDA regulations and guidelines as a part of the overall requirement that equipment be suitable for its intended purpose.

What are the Benefits of Computer System Validation?

Validation of software can increase the reliability and usability of the systems. This will result in decreased failure rates, fewer recalls and a decrease in the need for corrective actions. It satisfies the very important criteria of leading to less risk for patients and users, and reduces the liability of the manufacturers.

Validation is also a critical tool for assuring the quality of device software and software automated operations.

Validation reduces long-term costs by making it easier and less expensive to reliably modify software and revalidate software changes.

Establishing comprehensive software validation processes can help reduce the long-term cost of software because it reduces the cost of validation for subsequent releases of the software.

How Does Computer Systems Validation Work?

Computer systems validation is not a one-time event. This is stated quite clearly in Annex 11 of the European GMP directive:

Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.

Validation starts when a user department has a need for a new computer system. The department then considers how the system will solve an existing problem.

For an existing computer system, validation starts when a system owner is given the task of bringing the system into a validated state.

Validation ends only when the system is retired. At this point all important quality data should be successfully moved to a new system.

Important steps in between these two processes include planning of the validation, defining user requirements, defining functional specifications, defining design specifications, maintaining validation during development, procuring vendor assessment for purchased systems, installation, initial and ongoing testing and change control. Computer systems should be validated during the entire life of the system.

The complexity and the extended period of time involved in the computer validation process is often broken down into life cycle phases for clear organization. The model discussed below is the frequently used V-model:

What are the Guidelines and Regulations for Computer Systems Validation?

Various regulatory agencies have developed similar expectations for computer system validation based on the life-cycle organizational method.

A great deal of emphasis is placed on documentation of the software development and quality management.

Below is a list of the guidelines and regulations available for Computer Systems Validation:

ISO 13485:2003 Section 7.5.2

TR14969: Guidance on the application of ISO 13485:2003

FDA General Principles of Process Validation

CFR21 Part 820. Section 820.5, 820.75a and 820.100

GHTF Process Validation Guidance: GHTF/SG3/N99-10:2004 (Edition 2)

EN-60601-1:2005 Medical Electrical Equipment

What is the Good Automated Manufacturing Practice (GAMP) Guide?

Good Automated Manufacturing Practice or (GAMP) and the ISPE Guide, describes a set of principles and procedures that ensure pharmaceutical products meet required quality standards.

The core principles of GAMP state that quality cannot be tested at just one point for a batch of product. It must be built into each stage of the manufacturing process. The result is that, GAMP covers all aspects of production. This includes everything from the raw materials, to facility and equipment, to the training and hygiene of staff.

Standard Operating Procedures (SOPs) are an essential component of all processes that affect the quality of the finished product.

The GAMP guides also provide accepted methods for validating automated systems. It ensures that systems are developed using impeccable practice and meet agreed specifications.

GAMP 4 has been in place for years and GAMP 5 is the currently active version of the guidelines. Systems that are produced according to the guidelines set forth in this Guide will also meet EU and FDA requirements.