Pharmaceutical and biotechnology companies need to assure product quality using validated equipment and computer systems. Computer Systems Validation (CSV) is the process of ensuring that equipment, software, spreadsheets, utilities, and other computerized processes are compliant with state and federal regulations governed by agencies such as the FDA, EMA, and WHO. Validating these computerized systems to make sure they meet regulatory standards was traditionally done on paper. However, modern advances in computer technology enable CSV using electronic, paperless validation and tracking. Although paperless methods seem intuitive, regulatory guidelines also apply to paperless validation methods. Furthermore, CSV in manufacturing life sciences products is subject to inspection and auditing in the pharmaceutical and medical device industries.
When being audited by the FDA, the inspector’s requests need to be fulfilled in fifteen minutes or less in order to for the company to appear in a “state of control”. One way to improve efficiency during inspection is to utilize a well-organized electronic document and quality management system. For instance, PSC Software®’s – ACE Inspection® is an inspection management software that organizes your team and your quality documents during an inspection for optimal team communication and document management. PSC Software also offers ACE Enterprise® which has expanded capabilities and customized modules for individualized requirements, unique project needs, and multi-project management for companies seeking to expand their cGxP compliance tracking beyond the inspection day. Find more on inspections in our blog series on the subject.
By incorporating your CSV methods into your Quality Management System, your resources for audit requests are centralized, readily-accessible, traceable, and cGxP compliant. PSC Software’s Adaptive Compliance Engine (ACE®) is an electronic Quality Management System that integrates product quality assurance and computer systems validation. Furthermore, ACE is adaptable to the modern Computer Systems Assurance (CSA) method of meeting regulatory standards for validating computerized systems. CSA adopts a risk-based approach to validation, as encouraged by regulatory agencies. Find more on CSV vs CSA in our white paper on the subject.
Other benefits of paperless validation include remote capabilities, real-time collaboration, cost savings on paper, and improved efficiency, transparency, and traceability. Altogether, paperless validation is an essential upgrade to pharmaceutical and medical device manufacturing compliance methods. As of August 2021, ACE v2021.2 and higher supports a fully integrated paperless validation solution with 21 CFR Part 11 compliant electronic signatures.