Does anyone know of software that my firm can control documents by checking records in/out?

Does anyone know of software that my firm can control documents by checking records in/out?


I recommend just use MS Windows and make folders read-only as appropriate. Or, make an intranet if you prefer. All this checking in and out and "automatic" messaging brings a lot of effort and overhead with it.

Unless you are in a very large company, the software database systems bring a LOT of effort and very little benefit.

Does anyone know of software that my firm can control documents by checking records in/out?The simple answer to your question is YES! I know lots of software programs which INCLUDE checking records in/out.

The point is "every software solution is not for every organization."

Based on your previous posts and very scanty Profile, I presume your organization produces a product or service that falls under FDA guidelines. The system of checks and balances required in FDA-regulated organizations narrows the field of acceptable solutions. One of the MAIN FDA requirements is maintaining an audit trail and preventing unauthorized modifications to a record.

There are some tips the experts here at the Cove can give you in narrowing your search, but you really need to do one of two things:

give more information about your organization size, number of documents, number of authors/record keepers versus record readers and users. Also, whether all authors/users are located in the same physical premises or whether you will need access over a secure internet connection.
consider having your organization hire a consultant familiar with FDA-regulated organizations similar to yours who can shorten your learning curve by presenting a short list of appropriate software which you can preview and try out for a demonstration.
As an aside:
It is important for FDA-regulated organizations to maintain tight control of ALL documents, not just records, especially in the creation-approval stage.

:topic: Helmut's suggestion is really only appropriate for VERY small organizations and isn't quite as secure as other solutions. Depending on your product and your supply chain, you may need a more robust solution than available through a "home-made" one using MS Windows software.

As an aside:
It is important for FDA-regulated organizations to maintain tight control of ALL documents, not just records, especially in the creation-approval stage.

:topic: Helmut's suggestion is really only appropriate for VERY small organizations and isn't quite as secure as other solutions. Depending on your product and your supply chain, you may need a more robust solution than available through a "home-made" one using MS Windows software.


I certainly agree. My recommendation is suitable for ordinaty situations, because I feel the database systems are too rigid and tedious. However, industries which are heavily regulated certainly need to be able to demonstrate the flow of documents more formally. There are outside stakeholders who will have an interest in the records.

:topic: Helmut's suggestion is really only appropriate for VERY small organizations and isn't quite as secure as other solutions. Depending on your product and your supply chain, you may need a more robust solution than available through a "home-made" one using MS Windows software.

I don't think I agree with the "VERY small organizations" part. I think it hangs on the requirements for control.

I guess it depends on one's interpretation of a definite integer for "VERY small."

My guess is that once folks with whom you do not have a close working relationship and a LOT of trust have access to documents and, worse, the ability to modify those documents or records, issues of security begin to raise their ugly head.

"Trust, but verify!" is definitely a watchword in the FDA sphere. One need only look at recent issues of melamine, heparin, lead paint, etc. to see a strong need for bullet proof documentation and record keeping even (or especially) in small organizations. It seems obvious in each of those cases there was a serious lapse in record keeping throughout the supply chain composed of both small and large organizations. Without a robust system of checks and balances and audit trails, accidental or purposeful nonconformance to requirements and Standards seems inevitable.