A GCP Computer System Is a Lifetime Responsibility
Teri Stokes · 2000
Regulatory authorities require life cycle management for GCP systems both during the systems’ development (referred to as the software development life cycle, or SDLC) and for the rest of their existence through to retirement and replacement. The initial validation plan prepared by users for user acceptance of a new GCP system must include provisions for the “care and feeding” of a validated system for the rest of its life—after startup through to retirement. The computerized system validation (CSV) package developed at system launch must also establish the ongoing validation environment to keep the system “fit” and performing as expected over the years it is being used. Such long-term planning requires the involvement of management to ensure a supply of user resources to support the system over time. This first of a series of articles on the subject of system validation discusses the user’s role in the process. Later articles describe the roles of the software supplier and of the system installers.