Cloud computing has been a game-changer not only for life sciences companies but for validation engineers as well. The V-Model for validation was based on a waterfall "V-Model" and rigid change control processes that mandated documentation of any changes associated with validated computer systems.
In the age of cloud computing, the principles of validation endure. Any system used for cGMP, 21 CFR Part 11, Annex 11 or any other predicate rule requirement STILL requires validation. As your company seeks to adopt advanced systems such as Microsoft Dynamics AX, Dynamics 365, Oracle e-Business, Veeva, BatchMaster, Fullscope EDGE or other systems, the question becomes how do we validate these cloud-based systems and ensure sustained compliance. The answer is the CloudMaster 365™ Validation Accelerator - an integrated solution designed to optimize the validation process through lean validation methodologies and automation.