Context
The customer is a Belgian company with international exposure, providing flexible, tailored business solutions for the follow-up of medical studies or trials. In this business, it is important to be able to show that the quality of the provided solution is in line with the rules and regulations of the pharmaceutical sector.
Need
This company has asked Quasus to assess their current procedures in order to identify the remaining gaps and to build an action plan to fill these gaps in a short timeframe.
Solution
The Validation Maturity Model Assessment was executed in order to verify and document if the new self-developed system met the validation requirements as documented in the Validation Maturity Checklist. This checklist enabled Quasus to determine whether the company would perform the required functions and whether the customer complied to the validation requirements, as a supplier of a validated system. A team of 3 Quasus validation consultants performed this assessment: an Interviewer, a Scribe and a Document Writer.
Benefits
Quasus provided a clear status of the client’s compliance with local and global regulations. As a result, the client was able to improve the overall quality of the developed application. The Quasus-consultants provided recommendations and an action plan to reach full compliance with the applicable regulations, and provided practices to maintain documentation up-to-date.
