What makes a great validation company?
I’ve spent 16 years in compliance-related positions on both sides of the table. I’ve seen a lot of validation companies and interacted with a lot of validation departments, and I can tell you they’re not all the same. Here’s some criteria to help differentiate between a good validation company (who will create and execute protocols for you) and a great validation company (who will offer so much more):
- Experience with a wide range of equipment: A great validation company has experience working with the major equipment suppliers to the pharmaceutical industry, and has developed solid relationships with these manufacturers in order to quickly obtain the information required to develop protocols for their machinery.
- Breadth of scope: Experience with lab, utility, IT systems, packaging, process and facility systems and equipment ensures that your validation supplier can service all of your needs, creating efficiencies.
- Breadth of offerings: Your great validation suppliers should offer GAMP, Auditing Services, Quality Plans, Validation Master Plans, Protocol Generation & Implementation, Summary Reports, Computer System Validation, Project Management, SAT/FAT Generation & Implementation, SOP Development & Review, Equipment/Process Specifications, URS/FRS/DDS Generation, and cGMP Training Courses.
- Business sense: A great validation company realizes that validation is a regulatory requirement within a business environment, not a science in itself. An efficient common sense, risk-based, pragmatic approach to validation should be employed to fulfill all regulatory documentation requirements efficiently with a minimum of interference to operations.
- Engage the manufacturer: Resources at a great validation company should have experience as an equipment manufacturer with in-depth knowledge of equipment design and assembly, allowing them to engage with the equipment manufacturer throughout the system lifecycle: design, build, testing, and installation.
- Integration with your resources: Your validation contractor must be experienced working with all stakeholders: quality, operations, validation, maintenance, IT, etc., ensuring that they all understand the process and work to bring them together throughout the validation process.
To get the most out of your outsourcing dollar, make sure you hire a great validation provider.
