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How Does Computer System Validation Help Pharmaceutical Quality?

Computerized systems are increasingly becoming the norm across every industry, including pharmaceuticals. As such, computer system validation (CSV) has become an important part of pharmaceutical cGMP, often provided along with qualification and calibration services by accredited labs or compliance service providers.

Why is Computer System Validation Important?

According to the FDA, validation is “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”. This definition includes processes maintained or controlled by computer, or software systems.

Essentially, CSV falls under the domain of process validation, since the performance of computer systems and software affect the accuracy, consistency and reliability of data used in pharma manufacturing. In this case the “product” is data or control information, and the “process” is the system in use.

What Processes are Required for Computer System Validation?

Based on current Good Manufacturing Practice (cGMP), processes that rely on software and computer systems should be designed in a manner that meets pharma manufacturing standards. They should also be tested to ensure that they will perform consistently. Both of these objectives can be met if the following processes are in place:

  • Development of a VMP (Validation Master Plan)
  • Use of SOPs (Standard Operating Procedures)
  • Documentation of training for personnel on the SOPs in use
  • Details of specifications that are required for the system
  • Development of test scripts or a test plan for the system

What is the Role of CSV During the Software Development Life Cycle?

CSV has an important role in any activities that take place during the software development life cycle (SDLC). Various forms of testing and related activities have to be performed at every step of the SDLC, and these are primarily classified in two ways:

  • Static Testing – This includes review/analysis activities that can be conducted without actually executing the software, such as walk-throughs and inspections.
  • Dynamic Testing – This includes review/analysis activities that are conducted after the software is executed, to compare its performance against the expected results.

Since software and applications are highly dynamic, changes in any part of the system can invalidate previous CSVs. This is why validation is an ongoing activity, applicable to hardware, software, devices linked to the system, as well as the personnel using it.

Features of Computer System Validation

Here are some of the main features of a proper CSV:

  • User-Driven – Unlike certain other kinds of validation, CSV is driven by and needs to be performed by the user (the business using the software). IT suppliers, consultants and other organizations may play a role, but the organization itself needs to ensure the proper documentation of validation activities.
  • User Specifications – For CSV to be conducted at all, the organization needs to list its requirements from the system, defining how the software meets its business needs. These form the basis of the validation process, and are known as User Requirements Specifications (URS).
  • Functional/Design Specifications – The system’s supplier must provide details of Functional Specifications and Design Specifications, which relate to the URS provided by the user. These may be developed retroactively, through a reverse engineering process analyzing the system’s functionality and design.
  • User Involvement – The organization (user) has to be involved in every step of the software development process, but the level of involvement depends on whether it’s a custom-designed system or a package-based one.
  • User Testing – There are 3 levels involved in user testing for CSV:
    • IQ (Installation Qualification) – Here, the focus lies in testing whether the system has been installed correctly.
    • OQ (Operational Qualification) – In this level, the functionality of the system is tested after installation at the user site.
    • PQ (Performance Qualification) – This is where the ability of the system to meet business objectives is tested in the production environment.

CSV Has Become an Integral Part of the FDA Environment

Computer system validation has become an important part of FDA compliance regulations for pharma companies. Failure to include proper CSV in your validation program can lead to inspectional observations and warning letters. Further, if corrective action isn’t taken in time after a regulatory inspection, you can face fines, legal proceedings, and worse!

Author Bio: Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines. He also invites people to visit his company www.rscal.com to learn more about the type of calibration work he does.

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