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What is Computer System Validation?

Computers are widely used during development and manufacturing. Proper functioning and performance of software and computer systems play a major role, reliability and accuracy of the data.  Computer System Validation is the process of compiling written verification of all system functions and the performance of those functions to system specifications, as well as data integrity and system maintenance. And the written documentation must be in alignment with the industry standards. Therefore, computer system validation (CSV) should be part of any good development and manufacturing practice. It is also requested by FDA regulations and guidelines through the overall requirement that “equipment must be suitable for its intended use”.

Why Need Computer System Validation?

Companies strive to create goals, processes, culture, management, and incentives that build infrastructure. Computer Systems are a dominant and increasing part of business infrastructure. Computer System Validation is process validation and has the following benefits:

  1. Excellent Return On Investment (ROI) – Cost of compliance is low with respect to
  2. Potential loss of intellectual property or other potential losses.
  3. Provides documentation required by FDA, other regulatory agencies, and your customers.
  4. Maximizes the value of the computer system and the employees that use it.
  5. Reduces labour costs by increasing employee efficiency and effectiveness.
  6. Enhances project management to ensure projects are implemented on schedule and on budget.
  7. Saves money by discovering defects early, before failures occur in production.
  8. Reduces risk, Legal liability, not regulatory, is often the most important reason to perform validation. Software is made and used by people so it is guaranteed to be imperfect. Software and process defects increase with software complexity. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.

Why should I Validate my computer system?

It is required by the regulatory agencies to ensure product safety through automated process:

  • FDA Requirements (21 CFR Part 11)
  • EU GMP Annex 11
  • ISO Certification
  • To make sure that your system is living up to its expectations

Which system should be Validate?

  1. System that control the Quality of product during its development, manufacturing, testing and handling process.
  2. System that create, Modify, maintain, archive, or transmit data used to prove the safety, efficiency and quality of product.
  3. System that provide information on which decision are made affecting fitness for purpose of products.

  1. Automated manufacturing Equipment
  2. Automated Laboratory Equipment
  3. Process Control Systems
  4. Process Analytical Systems
  5. Manufacturing Execution Systems
  6. Laboratory Information Management Systems
  7. Manufacturing Resource Planning Systems
  8. Clinical Trials Data Management Systems Vigilance systems and  Scientific Document Management Systems