CONVAL group auditing services follow a proven methodology to evaluate organizational structure, policies, procedures, and practices concerned with computer systems. The audit is aimed at identifying, evaluating, and eliminating potential weaknesses , undercuting the realization of bussiness objectives or compliance with legal and or regulatory requirements in the IT and business environment. Our services accommodate enterprise-wide systems or single installations of a individual application.
Validation provides documented evidence, to a high degree of assurance, that the computerized systems are accurately and reliably installed and can perform their functions as intended for use. Validation is a GMP requirement. All pharmaceutical companies require validation as a part of their total quality and GMP functions.
CONVAL group offers a complete range of Computer System Validation (CSV) and 21 CFR Part 11 services/solutions to companies operating in the FDA regulated environment. FDA regulation 21 CFR Part 11 has a profound impact on the Life Sciences Industry and we can help you meet the challenges. This regulation introduces specific controls on the use of electronic records including strict administration of electronic signatures. Electronic records will replace paper records while electronic signatures will become as secure and legally binding as handwritten signatures. For FDA regulated companies, the path to compliance with 21 CFR Part 11 requires transitioning current systems and establishing an appropriate ongoing validation environment.
CONVAL group, as a leader specialized in regulatory software testing and validation services, helps clients to ensure that their business systems are in compliance with related regulations.
CONVAL group ensures that all elements of the manufacturing processes are validated in compliance with the regulations to minimize business risk and enhance the ability to compete successfully in the pharma industry.
CONVAL group supports all qualification requirements on the existing or new equipment as well as design, design review, selection and installation.