Optimizing Processes, Enhancing Data Integrity and Security
Few, if any, biotechnology and pharmaceutical companies question the growing importance of digital technology in managing information and processes. For CEOs, COOs, and general counsel, digitalization is a matter of when, not if. For quality and production departments, the question is if not now, then when?
In the collective rush to embrace new technologies for managing information, one thing must be addressed: How can companies maintain control and enhance the reliability of computerized data, processes, and procedures while staying compliant. The answer is: Computerized Systems Validation (CSV).
A comprehensive approach: better patient outcomes, processes, and compliance
Conducting the computer system validation process the right way requires a comprehensive approach, one that takes into account the workflow and the complex, ever evolving GMP environment. At GxP-CC, we have the knowledge, experience, and tools for complete validation. We have helped clients around the world clear new thresholds of systems control while staying aligned with standards and regulations. Our focus on better patient outcomes and deep expertise in both the workflows and the evolving regulatory landscape deliver our clients’ success.
What does a successful validation process look like? Increased product and service quality levels, staying compliant with regulations, enhanced information security, continuous improvement, and process automation optimized for the business. It also means a significant drop in IT information system errors, in data integrity issues, and in compliance risk. Even more importantly, a successful validation process lays aside all licensure issues.
Our computer system validation team consists of audit and computer validation experts who have the tools and the knowledge to implement process change without conflicting with regulations. We know the requirements of FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 and how to meet them. We know emerging rules and their possible influence on the marketplace. We dive into the issues to solve them, rather than skim the surface and address only the symptoms. We think about patient outcomes first because we know they’re what ultimately drive sustainable business growth.