The selection and purchase of an automated, rapid method is just the beginning of the process. Once selected, the technology must be installed and validated. Validation is a time-consuming and detailed process that involves departments outside of the quality control laboratory. Two of these departments, IT and quality assurance (QA), struggle with resources constraints much like the QC lab. Anything that can be done to help these departments accelerate or streamline steps in their process can shorten the time to value for the new rapid technology.
In the case of the Growth DirectTM System, there are two specific activities that can be performed before the product arrives at the facility. These two steps can potentially save weeks and allow the organization to focus on other parts of the validation process once the instrument arrives.
Step 1: Providing a Reference Computer for IT Testing
Before a new technology can be put on the network, there are a litany of tests that the IT department must perform on the software to assure it complies with internal policies and external regulations such as 21 CFR Part 11. In the case of the Growth DirectTM, a reference computer is available with all the technology software loaded and is ready to operate as if it were installed on the device. This provides a significant benefit to the IT department, and lets them assess the technology and prepare for any activities that must be performed once the instrument arrives.
Recently a customer noted, “I would recommend pre-shipping a machine (black box) whenever possible. We were able to work through several IT and sample preparation issues and should be able to hit the ground running for the validation.”
Step 2: Pre-review of Validation Documents with QA
The QA department plays an important role in the validation of the new rapid method. They must review the documentation both initially and the results of testing afterwards. These detailed reviews take time and can go through multiple iterations before final approval. The sooner the QC lab can get documents to the QA area, the faster the review and feedback can commence.
Rapid Micro Biosystems offers standard validation documents that can be provided before the instrument arrives on site. These documents can be reviewed and updated as necessary such that when the instrument arrives, the testing can commence right away. Again, this has the potential to save days or weeks in the validation process.
There are many variables that can impact the timeline for a validation process. Getting a head start on these two steps can directly impact the time it takes to bring the Growth DirectTM System into routine use.
For more information on the services provided to support the validation process, visit our services page.