QUMAS Compliance & Quality Solutions for Contract Organizations

The goal of every Contract Research or Contract Manufacturing Organization is to meet and exceed the expectations of their sponsor company.

By proving their ability to adhere to Regulatory requirements throughout the Drug Discovery and Development phase, Contract Research Organizations can ensure they meet not only the expectations of the Regulator, but also of the sponsoring partner.

By proving excellent Quality Assurance throughout the manufacture of drugs, the Contract Manufacturing Organization is in a position to separate themselves from their competition. Having an automated Quality Management Solution to manage Deviations, CAPA’s, Audits (regulatory and supplier) ensures that quality standards can be measured, maintained, analyzed, and trended, in a way that is accessible and attractive to sponsors. An integrated Quality Management solution provides Contract Organizations with the ability to feed information from one process to another e.g. CAPA to Change Control, making it an efficient and effective process, reducing duplication of effort. By receiving high quality batches from the contract manufacturer, the sponsor company can operate in the confidence that there will be less batch wastage, and rework, leading to higher margins and profitability for the organization.