Why are requirements and specifications needed in validation?
Validation is testing a system to standards or acceptable criteria. If your own requirements are not in place, then you will end up validating a system to someone else’s standards. There are thousands of features and conditions to consider and considering them beforehand allows your company to make an informed decision about the products you’re looking to buy.
Think of validation like the final check list before you say “I do” at your wedding. If you simply want to be married, anyone will do, very little vetting is needed. However, to ensure a long-lasting, happy marriage, the wise bride or groom will have in place a checklist of attributes and behaviors that their perfect partner should possess. Having a vendor perform validation is like having your spouse’s parent perform the validation – it runs the risk of being biased, and so it should be supplemented. Whether creating specifications and requirements for a partner in marriage or for a piece of equipment, you’re making sure that match is perfect.
There are several types of specifications that we use in the biopharmaceutical industry.
User requirements are just that, the requirements needed by the end user as required by the product, the process, safety standards, and engineering principles. At a minimum, there will always be at least one user requirement – this is the driving factor behind the purchase. Does the system perform well in the given range needed? Can it operate for the length of time needed? Performance qualifications governed by User requirements make sure that all needs are addressed, and nothing get overlooked in validation. Having these URS documents make you validation fluid and traceable.
Functional specifications lay out the desired behavior of the equipment or system you’re looking to purchase. Does the equipment perform within any required tolerances for analytical data? Does the system need to provide maintenance reminders? Does the system need to print out reports immediately? How many users will be using the system, and can it operate effectively with all users? Does the device need compliant software? Can it be integrated with the existing automation system? Can the system interface with mobile devices?
Design specifications are the conditions that are required for your process or that are already present at your business. What are your space requirements? Can it take up as much space of a biosafety cabinet, or must it fit on your bench top? Do you need 220 V or 120 V electrical supply? Does associated software require a specific operating system? Can it work in a room where harsh chemicals are being used?
Purchasing equipment is going into a long-term relationship with a company. It should be an informed decision. By having a URS, FS, and DS in place for each piece of equipment, you provide your employees with the tools to make them active and informed purchasers. Once the equipment has been purchased and is on site, your validation team will have solid, effective references beyond tribal engineering knowledge. Validating the system becomes straight forward. The tests performed, and the reasons behind performing them are present. So, when you’re at the altar looking at that equipment, you’ll know that all the tests have been performed, all the deviations resolved, all the needs addressed, and the doubt removed. You can say “I do” to your beautifully validated system.