An optometry center associated with a major university began conducting clinical trials for a major pharmaceutical company. Before they began, they were audited per the pharma’s vendor procedures. The center had never needed to be compliant with regulatory agencies in this way; at the time of the audit they had no official Quality Program, no technical solutions for data and document storage and security, and no validation of their data gathering spreadsheet to be used for the studies. They wrote some procedures on their own and purchased a COTS add-on package to make their spreadsheet 21 CFR Part 11 compliant.
But these efforts were not enough to mitigate the audit gaps. They turned to HCS, and we completely renovated their entire Quality Program and filled in the validation gaps in less than 80 total billable hours. In this case, we were able to restructure and enhance existing documentation to create a robust, compliant program. We identified security gaps in their existing local hard drive data storage and backup process and recommended a more secure solution with audit trail and backup capabilities. We also created custom tools for training, vendor management, and periodic review to accompany their new suite of policies and procedures. They were able to respond to the audit with success and begin the trials.
A small company with a remarkable text messaging app began working with clients conducting clinical trials. Because their new clients’ vendor requirements mandated HIPAA and 21 CFR Part 11 compliance, the company needed to create a Quality Program and validate their software for the first time.
HCS performed initial assessments and provided training for the entire staff, including the CEO, CTO, and developers. We then established an action plan to achieve compliance that included computer system validation and the creation of an entire Quality Program customized to their needs. The Quality Program was streamlined and deliverables were combined into a total of 10 policies and procedures. The system was validated; again, deliverables were efficiently combined. Functional requirements, risk assessment, testing requirements, and traceability were neatly aligned in a simple, concise matrix that served as the core of the validation. Test execution and summary rounded out the project.
But this project was not without its challenges. The company procrastinated approving their policies and procedures for nearly a year, despite our best efforts to keep the work moving. As a result, the company lost at least three potential new customers due to negative audit findings. They regrouped, we completed the project milestones together, and now they are sailing through audits and gaining new clients.
For this project, HCS provided a streamlined, risk-based validation approach for a client’s unmodified Laboratory Information Management System (LIMS). This served as a baseline for the client’s instances of customized/configured LIMS in their GxP labs. The entire effort was planned, executed, and summarized in four weeks, and its effectiveness earned a 90-minute presentation in the IVT 17th Annual Validation Week conference in 2011: the largest and most comprehensive validation event in the life science industry.
A carefully developed Validation Plan is the key to any successful validation effort. In this example, Hart Consulting combined an airtight scope with a thorough description of the activities and documentation to be performed, resulting in a solid plan that clearly defined the strategy of combining vendor-provided qualification documents with the creation of requirements specifications to execute and summarize testing based on known risks.
Test execution was traced to requirements in the final summary document, which also included a CFR 21 Part 11 Assessment. This approach provided simple yet comprehensive conclusion of the validation activities as well as proof that the system was fully qualified and ready for use.