Validation Policy
If you have questions about any of our policies, please contact us at: general@meliorsolutions.com
Introduction
Validation procedure
Melior Solutions is committed to ensure that development, operations, and maintenance of our product application to achieve continuous quality outcomes, as well as compliance with all relevant regulatory requirements. Validation, in accordance with Good Manufacturing Practice (GMP) principles forms a key strategy in this commitment. Validation at the site is performed in accordance with the GAMP5 Guidelines for suppliers of computerised systems to the pharmaceutical industry:
- All new products/projects shall go through the validation process to ensure they meet the regulatory expectations of both Melior and our customers.
- We will identify critical development, operations, and maintenance processes within the business. These processes shall follow defined procedures in the form of process flows.
- Our validation process should reinforce GMP and where applicable follow GAMP5 as a supplier of IT to the pharmaceutical industry.
- Information and conclusions obtained as part of the Validation process will be documented, including those of test results.
- We should be able to demonstrate that the validation process has been appropriately planned, managed, recorded, approved via deliverable documentation and that the system is fit for purpose.
What is an EOT?
Employee Owned Business
Melior Solutions, a company where every member is an owner, driving our commitment to collaboration and equality.
Get In Touch
General enquiries
Have a question for us? Want to find out more?
Please complete a few details to the right and we will be right with you.