With the current trend of corporations transforming their operations to a paperless environment, regulated industries are facing issues of validity and compliance of their computer systems and applications. The challenge of keeping pace with the impact of technology on their operations, while addressing and meeting new guidelines and regulations, has become an imperative and time consuming task. In order to permit the use of electronic technology in FDA-regulated industries, including pharmaceutical, biotechnology, medical devices, etc., the new 21 CFR Part 11 regulations regarding security, traceability, and integrity of electronic records and electronic signatures need to be enforced for all computer systems.
Working with a professional IT & Turn-key Automation Engineering and Consulting firm such as Xyntek, with hands-on technical expertise and in-depth knowledge of Computer System Validation in the regulatory environment, you can ensure that your company's Part 11 requirements will be completed in a cost effective and efficient manner. Xyntek's team of validation and automation professionals are fully trained and experienced on 21 CFR PART 11 requirements, and are ready to assist your company with the issues and challenges in hand. Our services include:
- Increase company wide awareness and knowledge of 21 CFR Part 11
Provide detailed compliance strategy for new and legacy systems
- Conduct full system assessments on all of your company's GxP systems and develop a Gap Analysis that will result in a 21 CFR Part 11 compliant solution
- Review and research technology issues that will provide remediation actions for Part 11 gaps and/or features
- Recommend, and implement technology tools for electronic records and electronic signatures
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