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