Meet critical deadlines
Mitigate time and resource constraints
Reduce risk by improving the quality and clarity of document content
QReview is QualityHub’s latest offering to clients, an On-Demand remote document review and consulting service, that gives you the expertise you need, when you need it.
The client, a large pharmaceutical company, was in the processes of revising their supplier approval process. An internal cross functional team had worked on a new procedure for Supplier Evaluation and Approval but the team lead wanted the input of an outside subject matter expert (SME) who would have worked on several similar processes in other companies and could share “best practice”.
QualityHub was contacted and quickly connected the client with one of our consultants with expertise in Supplier Controls. The client submitted their new procedure through a private secure SharePoint site established specifically for them. Utilizing hours available in their QReview subscription, the SME reviewed the procedure remotely and provided redlines and comments. A few collaborative work sessions were then held remotely using a videoconferencing and a desk-top sharing application, allowing the consultant to provide input and coach the team. In the end, the client benefitted from suggestions from the consultant on both content and terminology to better align with industry standards, and improved organization and clarity of the procedure before it was submitted for management approval.
A medium-sized medical device company was in the process of modifying the design of a Class II device based on user feedback after the first couple of years on market. The device had originally been cleared by FDA under a 510(k). After completing the FDA’s decision trees for when to submit a design change, the Regulatory Affairs Manager had questions about the possibility of submitting a Special 510(k) for this change instead of submitting a whole new traditional 510(k).
With the company’s QReview subscription, this manager had access to a pool of hours for consultation and/or document reviews. QualityHub connected the manager to one of their Regulatory Affairs Specialists having years of experience with a variety of submissions for medical devices. A conference call was scheduled, during which the manager provided background information and then asked several questions, getting real-time responses. After an hour of remote consultation, the manager had answers to questions, a strategy in mind, and confidence to move forward after having received feedback from an outside SME. The turnaround time from initial contact to talking with an expert was less than 72 hours and it did not require SOWs and Purchase Orders, just to engage a consultant for an hour.
A fortune 500 manufacturer of a combination product was in the process of transferring their latest auto-injector from design into production. The Director of Engineering had some concern that the Engineering and Manufacturing team, many of whom were just getting started in their careers, did not have much experience in developing process validation protocols that would be subject to an FDA pre-approval inspection. The Director of Engineering used their QReview subscription to request an outside subject matter expert review drafts of three process validation protocols prior to them being submitted for her review. This would save the director the time of having to heavily edit the protocols when she was already over-extended with this project and others as well.
A private SharePoint file was set up to allow the company to upload their protocols as they were developed. Upon receiving each protocol, the QReview SME, with over 20 years of experience in process development, process engineering and validation, reviewed and redlined the documents. Follow-up meetings were set up so the SME could explain his suggested changes and in doing so, coach the engineering team on how to justify their sample sizes with appropriate statistical methods and more clearly state the acceptance criteria. With a use of 9 hours of remote consult time, the Director of Engineering had three protocols ready to execute with confidence that the were aligned with regulatory requirements, guidelines for process validation, and industry best practice. In addition, a team of young engineers gained valuable insight into developing protocols that were clear, statistically valid, and executable.