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Companies are required to explain how they intend to validate their software and show evidence it has been validated the way it was explained.This lack of specifics from the FDA led to an excess of validation.VMware Validated Design is a family of solutions for data center designs that span compute, storage, networking, and management, serving as a blueprint for your Software-Defined Data Center (SDDC) implementation.
Adequate software validation consists of a range of aspects, from planning, system verification and validation to testing, traceability and configuration management.
Installation Qualification (IQ): The FDA defines IQ as “establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer’s recommendations are suitably considered.” For European companies, Annex 15 defines IQ as the “documented verification that the facilities, systems, and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.” Operational Qualification (OQ): The FDA defines OQ as “establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances.” Annex 15 defines it as the “documented verification that the facilities, systems, and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.” Performance Qualification (PQ): The FDA defines PQ as “establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.” Annex 15 defines PQ as the “documented verification that the facilities, systems, and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.” One way to achieve the “least burdensome approach” is to integrate validation into a change control process trigger, such as the installation of new software or an upgrade.
When incorporating validation into such an event, effort is more likely to remain focused on verifying that the change meets user requirements and is less likely to experience the “scope creep” often associated with validation.
Free Public Documentation For customer interested in implementing the VMware SDDC with in-house skillset, the VMware Validated Designs are available as free public documentation.
Documentation in a VMware Validated Design includes: Release Notes, Introduction Guide, Architecture and Design, Planning and Preparation, Deployment and Operations Documentation Read the free public documentation VMware Professional Services VMware Professional Services delivers the right expertise and collaboration for a rapid implementation of your SDDC architecture based on the VMware Validated Designs.