IT Infrastructure Qualification

IT Infrastructure Qualification

        IT infrastructure qualification is a process that validates that IT components are fit for their intended use and meet specific requirements. This process ensures that the         system’s fitness state is maintained at each stage of its life cycle. It’s a regulatory requirement and is applicable to key processes, providing control and insight into the IT         infrastructure used.

        The importance of IT infrastructure qualification lies in:

· Supporting the shelf life of your product by ensuring that the IT components are reliable, secure, and compliant with all relevant regulations.

· Reducing the cost and time of remediation of IT systems due to nonconformances to quality and compliance requirements.

· Enabling the use of information technology to improve operational efficiency, enable business innovation and transformation, and align your IT strategy with regulatory compliance needs.

· Enhancing employment prospects by validating knowledge and skill set in IT infrastructure management.

 

        IT infrastructure qualification, as per regulations such as 21 cfr. Part 11, Annex 11, is a mandatory requirement. It applies to crucial GxP processes and offers a measure of         reliability and understanding of the IT infrastructure employed in a GxP process.

 

Are your resources already ‘maxed out’ on other priorities?

 

 

No problem, let our people handle as much or as little as suits you & your budget.

Feel free to reach out to us for additional details on how we can assist you in deploying or qualifying your infrastructure.