Grantek’s project methodology begins with a detailed analysis of the clients’ desired need and required outcomes which leads to the development of a detailed User Requirement Specification, URS. The earlier in the process Grantek is involved, the more comprehensive and accurate our qualification testing and performance will be. The URS ultimately drives what needs to be tested. A Grantek-developed requirements traceability matrix (RTM) will ensure that our solutions meet the requirements outlined in the URS.
For life sciences clients, Grantek offers complete GAMP-5 validation capability. When Grantek initiates a project, our highly experienced staff not only provides the integration services but also helps ensure that the project meets the needs of the customer and complies with all applicable regulatory requirements.
Our engineers are experts at interpreting and applying GAMP-5 and ASTM E-2500 best practices to assist with qualification testing activities for the completed project. Most of our clients provide a format and a methodology for the validation tests and Grantek can also write the test procedures if necessary.
Factory Acceptance Tests/Site Acceptance Tests (FAT/SAT)
On all projects, Grantek conducts FAT and SAT testing to ensure that the automation integration functions as intended before it is put into production. Grantek uses a checklist approach for FAT/SAT. In pharmaceutical projects and any other project requiring formal process qualification testing, the FAT/SAT is completed prior to the commencement of qualification activities.
We can write and conduct the FAT as well as SAT procedures for your facility or assist your team in doing so. We conduct the FAT/SAT testing while the client witnesses it.
FAT is typically conducted at the Grantek office. For these tests, we simulate the inputs in a virtual environment to test the automation controllers and software without having to connect to the production equipment.
SAT is conducted onsite, and it generally involves more people from the client’s side— typically engineering at a minimum. Grantek also offers safety engineering services to help ensure that the safety provisions and safeguards are in place and functioning as intended.
For efficiency, we can write the SAT test procedures in a detailed manner that allows them to be leveraged so they can be reused and accepted as part of the validation OQ.
Typically, SAT begins with a complete I/O check: all external inputs are applied and corresponding outputs measured to ensure that the expected outputs are occurring. Next, a physical device test is performed, in which power is supplied to each motor, pump, valve etc. to ensure that each is connected properly and is functional. Then the devices in the system are manually exercised using the HMIs. All automated sequences are tested for functionality. For fast paced projects the client wants to see the device, wiring, PLC, HMI all communicating and working together.
Once basic commissioning is complete, the formal SAT procedure is run for pharma or food and beverage facilities, in pre-production mode. The test is reviewed with the customer and is typically signed by the Grantek project manager and the client’s designated representatives. IQ/OQ tests must be signed by the client’s validation team.
A validation master plan (VMP) is essential for a project. The VMP is, in short, a written procedure to describe the process of achieving and maintaining a qualified piece of software, equipment or a facility. It describes what will be tested, how the tests will be conducted, the documentation that will be required, and who must be involved during validation. Grantek can consult in the preparation of the VMP, or take ownership of its preparation.
Validation testing is usually performed by the client’s validation team, but Grantek is typically consulted during protocol development and execution. Grantek has written and executed many IQ and OQ protocols for our customers.
Grantek can also provide both support and consulting services to drive synergy between the software and electrical systems and the mechanical equipment supplied by the OEM. This can help ensure efficient troubleshooting if an issue is found during testing.
Grantek provides requirements traceability, based on the URS, FRS and DS. We can also author the protocols if necessary. We can prepare protocols and procedures using the customer’s templates and formats or using our own templates, which can be tailored if necessary.
At Grantek, our practices are integrated to ensure that all of our technical disciplines work together, resulting in very effective teams. Our engineers are trained in GAMP-5 and quality management system requirements, and are knowledgeable on the requirements of 21 CFR Part 11. Grantek has undergone many successful customer audits over the years. We are ready to assist with all aspects of your integration project, including the formal acceptance and qualification testing.