When a mid-sized pharmaceutical company was overwhelmed with day-to-day operations and didn’t have the resources to handle validation requirements, they turned to Court Square Group.
SUMMARY
A mid-tier pharmaceutical client was growing rapidly which created a strain on their resources of their IT and quality groups. To meet their FDA regulatory requirements, the IT and quality departments needed support for all of their systems and document validation. Management contracted with Court Square to lead this validation effort. The engagement soon broadened as Court Square’s expertise was needed to keep IT and QA in synch during this crucial time.
APPROACH
Court Square began by reviewing all validation documents, editing as needed with the client’s team and providing final approval. A validation plan was put in place to make the process flow smoothly. A validation summary report was created so that managers could view the status at any time.
Court Square’s quality consulting team reviewed all IQ/OQ/PQ results and checked for record completion before approving new systems for use. Court Square also completed software quality audits of the drug safety software vendor and implemented a vendor problem resolution process to address poor documentation issues at the vendor site.
As the project progressed the client increased Court Square’s validation responsibilities to the point that Court Square was serving as their virtual QA manager..
RESULTS
The project results were that the client had a documented validation plan and process for future needs. The standard operating procedures which Court Square created kept them true to the validation process. The project also proved the effectiveness of this process through the completion of a validation package for their current system issues.
The client avoided potential future audit problems with their software vendor as a result of the documentation issues that were uncovered and resolved by Court Square.
The most beneficial result for the client was that they were able to move to the next clinical trial phase as planned. This is something they would not have been able to do without the support provided by Court Square. The client also recognized that as their organization grew their needs were changing and that the processes put in place by Court Square would support them during this critical time and into the future.
The client’s drug safety system was signed off as ‘fit for use’ within the regulatory requirements and the validation process was put to use as release 2 of the Drug Safety System later that year.
SEE FOR YOURSELF
If time to market is critical for your organization or if internal IT resources are spread thin, contact Court Square Group to learn how our team of life science computing infrastructure experts can quickly provide support to help you meet your business objectives.
ABOUT COURT SQUARE GROUP
Court Square Group (CSG) (courtsquaregroup.com) is the leading provider of an Audit Ready Compliant Cloud™ (ARCC) platform for Life Science companies. The ARCC cloud platform and out-of-the-box tools provide a validated and cost-effective way to manage all digital content (EDMS/documents, voice, data, and video) in a regulated and compliant environment. CSG also provides cloud-based backup solutions for data integrity and data protection for in-house systems. At every stage of the development and manufacturing lifecycle, Court Square’s cloud, collaboration and regulatory submission solutions reduce costs, complexity and risks associated with sharing, storing, and submitting information for regulatory requirements. With over 1,000+ submissions and twenty-five years’ experience and a 95% client retention rate, CSG has a proven track record as one of the most cost-efficient solutions in the life science market.