Per 21 CFR part 11 and Annex 11 compliance, and suggested by GAMP 5, a risk based software validation (computer system validation, CSV) is a mandate. A secure environment must be maintained and CSV for electronic signatures and electronic records be maintained to ensure data integrity. Sarjen offers Software validation services to ensure a validated software environment for regulatory complicate.
Challenges in regulatory requirements, stringent regulations are forcing companies, especially pharmaceutical, life sciences companies, CROs, etc. to have an approach which aligns with the regulatory requirements, company strategies.
Even mega conglomerates are fined heavily for non-compliance which makes other companies jittery to ensure regulatory compliance, lest they fail regulatory inspection and audit.
Sarjen understands the regulatory requirements, makes understand the benefits of integrated compliance approach, rigorous and thorough training of software implementation.
Sarjen possesses rich exposure to various GxP standards as well as regulatory guidelines such as ANNEX 11 for computer systems, 21 CFR part 11, GAMP 5. Sarjen is also an ISO 9001:2015 (where ISO 9001 is internationally recognized as the gold standard for quality management systems) certified software development company.
Understanding the vital aspects of software validations, Sarjen provides validation consulting services based on these validation models by creating a systematic approach:
- Software development validation consulting services
- Software implementation validation consulting services
- 21 CFR part 11 and Annex 11 compliance
- Cloud based validation