Computer System and Software Validation

The importance of having computer system validation and software for mission critical operations and manufacturing processes is well understood and embraced by the pharmaceutical industry.

For those looking for automated systems, process control systems, manufacturing executing systems, laboratory information management systems (LIMS), document management systems, IT systems, you want to be sure that everything is compliant.

The level of computer system validation required should be established based on risk and the impact that a system may have on product quality. Computer systems are validated to ensure that the critical functional aspects of the system, as it pertains to the user’s “intended use,” satisfy the user requirements.

Computer and control systems are subject to more regulatory scrutiny for compliance to current regulatory expectations given the greater importance and complexity of computer and control systems used by manufacturers in assuring the quality of manufactured products. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated System presents an approach for industry professionals internationally to use for implementing validated and compliant automated systems meeting regulatory expectations. The GAMP guideline defines a set of principles, practices, and documents that form a consistent approach for professionals involved in engineering and validation of these systems to follow.

The set of documents required to establish documented evidence for compliance generally include the following documents:

  • Validation Plan
  • User Requirements Specification (URS)
  • Functional Specification (FS)
  • Design Specification (DS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Summary Report

How can Compliance Team help with computer system and software validation?

Our consultants are experienced with executing software and computer system validation projects. We have developed a streamlined ASTM E2500 approach and the associated procedures and templates to simplify and to control the cost of computer system validation. Whether your validation project is for a simple process control system or a complex IT system implementation—we stand ready to support you with our team of experienced qualified professionals.

Our expertise and project execution processes help ensure that our clients’ computer system is fully qualified through a structured approach consistent with the recommended practices established in the ISPE Good Automated Manufacturing Practice (GAMP) guidance.