A company was being assessed diligently by a prospective business partner, a major CRO that was representing the ultimate study sponsor, regarding a complex, high-risk, high-visibility FDA-related endeavor. The project was worth several million dollars to the company. The company had to complete a detailed questionnaire, in a very short period of time, regarding how the project activities would be performed and managed and the quality measures that would be employed to minimize regulatory risks. The company was to supply subject matter expertise and was collaborating with three other subcontractors that would provide needed technical expertise. What was missing was regulatory expertise, specifically regarding computer system validation and compliance to 21 CFR part 11 and HIPAA. Without the regulatory component, there would be no deal. And so, through a mutual acquaintance, the company was referred to The Practical Solutions Group, LLC and asked us if we could supply the missing piece.
In less than three days we developed a detailed quality plan based on the following control objectives:
- The system will meet the business needs of the study sponsor.
- The system will be developed, deployed, supported, maintained and used in a quality and compliant manner.
In addition, we worked with the other three subcontractors to help focus their attention on the types of quality control activities that they would need to incorporate into their responses and eventually carry them out. The details were included in the questionnaire and presented to the CRO. The result? “Go ahead” was given to start work immediately. Touchdown!