There are many different software companies out there that provide document control for FDA 21 CFR Part 11 companies. So many to choose from that if you do a simple search on Google for document management there are over 108 million pages you can choose from. So how do you know if they are validated systems? How do you know if they will work for you?
There is one easy answer: you decide what validation is.
That is right, the choice is up to you. You and your company have to define/interpret how it will meet the compliance standards set out by the FDA. You and your company have to decide how you are going to test the validation of the system. You and your company will decide if this is done by the software providers, a third party, or in-house. You and your company write the procedures, protocols, and set the time frame. The important thing to understand is that the decision is up to you.
That is something that most people are not aware of, they expect that the purchase of a software system means instant compliance, but it does not. The software is a tool, that if designed properly, meets the standard requirements as laid out by the FDA, in the 21 CFR Part 11 regulation. Such as having a mechanisms to control who can and cannot see certain documents, electronic notification, date and time stamp of applied signatures, and an established audit trail to name a few of the criteria. Since the requirements do not detail the exact look and feel of the software, is why you see so many choices available. Some will have the bare bones while other software will have an explosion of features and such complex sophistication you will think you have arrived in the year 2065. Just remember the following:
Having an electronic system alone does not make a company FDA 21 CFR Part 11.
So how do you begin your search? First, look at the claims made by the vendor. If a software company states categorically that their software is 100% compliant out of the box with no setup... you should look somewhere else. Second, see who their customers are. If the software vendor has a long roster of companies that must meet FDA 21 CFR Part 11 compliance, then you are on the right track. Third, ask if the vendor provides validation services, scripts, and/or recommends validation consultants. Lastly, how long does the vendor say it will take to validate the software and do their references back that up. That seems simple enough. Then throw on top the requirements your company has for a system and you are on your way.