Editors Note: In a four-part series from Applied Clinical Trials, Teri Stokes overviews the validation of a good clincal practice (GCP) computer system. Stokes discusses the structure of a GCP computer system, validation of the GCP platform and infrastructure systems, GCP software verification, and the quality assurance role in computer validation.
Download "Validating Computer Systems"
Part 1: A GCP Computer System Is a Lifetime Responsibility
"Purchasing a computerized system for use in a GCP-regulated work process is like buying a family pet. Like a well-trained pet, the system is expected to do what we want it to and perform as expected. No mistakes on the carpet, please! Don’t crash in the midst of our rush to prepare the final study report, please! Buying a pet is a lifetime responsibility that begins with the initial excitement of first encounters (housebreaking) and continues on for years with daily feedings and walks and health check visits. Buying a GCP system is also a lifetime responsibility, with initial validation (user acceptance) and ongoing change control, repeat testing, maintenance, enhancements, backups, and audits."
Part 2: GCP Validation of Platform and Infrastructure Systems
"Like the tip of an iceberg, however, multiuser and global GCP applications sit atop a huge, unseen, but necessary, mass of support. Below the application software tip is the rest of the sys-tem “iceberg”—a collection of server, desktop, and peripheral hardware, operating systems, database engines, query/reporting tools, and the communications networks needed so the application will work as intended. These components make up the platform and infrastructure systems usually supplied to users by the information technology/information systems (IT/IS) department."
Part 3: GCP Software Verification
"Software suppliers have a tough job. Writing software for use in a GCP work process adds an extra complication: preparing for many audits of the software engineering process itself as well as the software application produced...Part 3 explores the software supplier’s CSV package that documents the way the software was “built right” to meet its design specifications."
Download "Part 3: GCP Software Verification"
Part 4: The QA Role in Computer Validation
"Quality assurance professionals have important roles to play in computer validation work—roles that do not require them to be technology experts. The QA role in computer validation is to assess and support the quality practices surrounding the computerized system during its development, installation, and use in a GCP work process. The QA focus is not on the details of technology, but on the documented evidence used to prove to an inspector that the GCP system is under management control, that it reliably operates as expected, that it protects the integrity of electronic data during handling, and that its quality is auditable."
Download "Part 4: The QA Role in Computer Validation"