AVO Chief » Entries tagged with "Life Sciences"
Validation for Life Sciences
Validation A unique and very important part of the Life Sciences development lifecycle is validation. Validation requires documented verification that a process will produce accurate results as per the predefined specification. For this to work you need to know in advance that what you describe will function as detailed. And there are usually plenty of details to cover. In fact, validation impacts practically every area and phase of an automation project for life sciences companies. Most companies base the engineering effort required to create validation protocols and documents on the GAMP guidelines. These documents incorporate the requirement, design, implementation and test and verification phases. The documents that make up these phases will ensure validation compliance of the completed system implementation. They usually include at least some of the following: User Requirement Specification Design Spec Functional Specification Technical Specification Coding … Read entire article »
Filed under: Project & Portfolio Management
FirstDoc & Documentum can help Life Sciences compliance
An important consideration in evaluating the impact of FirstDoc/Documentum-based applications in helping meet 21 CFR Part 11 compliance is whether the specific system implementation is considered a closed or open system. The FDA provides the following definitions in 21 CFR Part 11 for closed and open systems: Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. Closed System Controls For closed systems there needs to be a way for “validation of the systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered … Read entire article »
Filed under: Content Management, Documentum