The way we work has changed post-pandemic. With remote work and services on the rise, our team is beginning to assess the importance of electronic execution in CQV projects to plan for efficient delivery in the future. Krunal Patel, ValSource Validation Consultant, is applying lessons learned and current pain points to contribute toward development of a process that allows for electronic execution on CQV projects.

Next Steps for CQV Electronic Execution

(As) Narrower Interpretation of scope of 21 CFR part 11 by FDA clarified only electronic records are subjected to 21 CFR part 11 are those records needed to meet predicate rules set by FDA for acceptance. Such clarification not only presents great opportunity for industry to employ a process that allows for electronic executions but also offers great management over project execution via better controls software technologies has to offer and can expedite project completion, deliveries efficiently and consistently.

Recent surge in advancement of software and hardware technologies including cloud based web operations can offer tremendous potential to support electronic executions for CQV projects providing single source of data along with enhanced controls for routine operations such as tracking real time progress, document workflow controls, consistent and clear records, improved requirement traceability, notifications of impacts for a change preventing compliance failure with assurance of secured data backups, audit trails or change log with protection of recorded data by user access.

Consult with ValSource

The goal of the CQV process is “to obtain a quality product manufactured in this facility.” Beginning with the end in mind, our consultants at ValSource work to ensure a facility — and the equipment in it — will function as required and be approved by the regulatory agencies that have jurisdiction over that facility. ValSource can support pharmaceutical and biotechnology projects throughout the full CQV lifecycle.