The FDA, and other similar regulatory agencies have started to take a top-down, system-based approach to inspections and audits, which is called the Quality Systems Inspection Technique (QSIT). Instead of looking at the end results of processes for small abnormalities, agencies are focusing on elements of the total quality system that are most important to meeting requirements. Reducing the number of systems being used to manage similar activities can greatly simplify future audits, with fewer systems to explain and less need for inspection.  “Facility and Equipment,” grouped by the FDA into one of the seven subsystems that make up a complete quality system, Validation is one major area that can now be brought into a single system.

Since Validation is not a one-time event and it is never “done,” it should be managed as a Lifecycle process, including post-validation monitoring. Currently, validation phases are managed in different systems and through different processes. In addition, post-validation monitoring is commonly overlooked, but it is required by regulatory agencies. FDA 820.75(b) for devices states that procedures for monitoring and controlling process parameters in validated processes must be established and maintained. Similar expectations are held of pharmaceutical and biotechnology manufacturers.

In addition, different validation processes are managed through different systems and different groups, including Computer systems, Equipment, Process and Cleaning validations. Validation task dependencies should be managed to enforce consistency and enhance compliance in the corporate quality process. For example, in a given manufacturing facility, computer systems should be validated before equipment and laboratory methods. Equipment and laboratory methods used in a process must be validated, before the process validation is performed. Cleaning validation should occur after process validation. It is not possible to enforce this sequence, or similar sequence, in the current manual process.

Managing all phases of the validation lifecycle and different validation types through a single system would help regulated companies manage the entire validation lifecycle process efficiently, dynamically tracking validation status in real time, streamlining the process and improving communication between all stakeholders. Taking this approach ensures and enforces compliance and consistency, throughout the entire corporate validation process.

ValGenesis is the first software solution in the industry that completely replaces the inefficient paper-based validation process with a more advanced web–based, compliant system to manage the validation lifecycle process, end-to-end electronically. ValGenesis is a fully modularized system with elements for Tracking, Validation Planning, Risk assessment, Requirements Management, Traceability Matrix, Document Authoring, Paperless Electronic Execution, Change Management, Periodic Review Scheduling and Content Management.

In addition to managing all phases of the validation lifecycle process, ValGenesis enforces validation task dependencies through in-built validation plans and projects. The module requirement of validating Equipment and laboratory methods before the process of validation can be enforced. ValGenesis helps to implement and enforce validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents.