CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Q: Our facility is limited by both time and budget constraints. How will using a third-party help me?
A: Outsourcing your validation allows your lab to concentrate on your core business. When organizations go outside their expertise, they can be drawn into unfamiliar functions and processes and could potentially take away from their main focus – patient safety. Many facilities are unaware of the intensity and extent of the validation process. In addition, they usually do not have the resources to perform the validation, either due to limited staffing or tight project timelines. And although a software installation is technically an IT project, it’s unlikely the IT staff can assist with the validation. This is meticulous work that requires laboratory personnel who are familiar with the workflow and regulatory requirements. Regarding cost, there can be significant savings when a business function is outsourced. Employee compensation costs, office space expenses, and other costs associated with providing a workspace are eliminated and free up resources for other purposes. A qualified third-party vendor can give you the time, the experience, and the cost control your facility needs.
Q: If I choose to use a third party to validate my software, will my staff still need to be involved?
A: Yes, to varying degrees, depending on the vendor. For example, vendors require access to system configurations and some initial Q&A in order to understand the client’s system parameters, background info, and workflows. There is also the review of the validation documentation. By regulation, the validation of the system software is ultimately the client’s responsibility, regardless of whether a third-party was used. The client must be familiar with the validation in order to answer any inquiries.