Computerized Systems Validation (CSV)

The term computerized systems validation refers to a set of validation activities performed in respect of computerized systems of a pharmaceutical company that are critical from the GMP prospective. This scope is usually expanded to include GxP-relevant systems, i.e. validation of computerized systems should be carried out for all GxP-critical computerized systems, which, in addition to GMP, may also have relevance with GDP, GAMP, GCP, GLP and other related codes of practice.

Validation of computerized systems involves both validation activities performed in respect of equipment / systems, i.e. related to Qualification, and activities in respect of software, procedures, etc., which can be collectively referred to as processes, i.e. related to Validation. Thus, validation of computerized systems has features of both equipment qualification and process validation.

Computerized systems validation should not seen as a one-time activity, but as a set of established validation processes that govern the entire lifecycle of a computerized system, from its design, implementation and use, to decommissioning, and ensure the system’s compliance with GxP requirements throughout its entire lifecycle.

In EU GMP Guidelines Annex 11. Computerised Systems, the following definition of lifecycle is provided, as applies to a computerized system:

“Life cycle: All phases in the life of the system from initial requirements until retirement including design, specification, programming, testing, installation, operation, and maintenance.”

Since validation activities for computerized systems should start very early in their lifecycle, these validation activities should go along with the entire pharmaceutical facility/system design process and are very closely related to it.

Validation of computerized systems is a very extensive and specific set of multidisciplinary activities that requires the involvement of various competencies, including process technologists, quality assurance, IT, instrumentation/automation and engineering services. All members of the validation team should be trained in the principles of computerized systems validation.

The most comprehensive guidelines that describe the policies, methods and tools that can be applied to validate computerized systems, as well as to ensure that a computerized system complies with GxP requirements throughout its lifecycle, are provided in the series of ISPE GAMP (International Society for Pharmaceutical Engineering / Good Automated Manufacturing Practice) guides, including GAMP5 and Records and Data Integrity (RDI) guidelines. The ISPE Guidelines are not regulatory documents and are advisory in nature.

Validation of computerized systems can be generally divided into the following steps:

  1. Project Identification
  2. Project Evaluation
  3. Validation Planning
  4. Design Review (DR/DQ)
  5. Installation Qualification (IQ)
  6. Low-Level Testing (OQ)
  7. High-Level Testing (PQ)
  8. Reporting & Release

Tarqvara Pharma Technologies specialists have years of experience in conducting qualification, validation and acceptance activities in the pharmaceutical industry in accordance with international, European and national regulatory requirements and GMP/GxP principles.


See also:
Qualification / Validation / Commissioning
Commissioning (FAT/SAT)
Risk-Oriented Approach