Accuracy is necessary as the FDA may inspect CFR part 11 records at any time. This set of regulations requires access controls, an audit trail, and restricted access to only allow authorized people to access the files. Thus, it is necessary to have an effective CFR Part 11 software tool so that you will have confidence in your ability to maintain accurate electronic records that comply with federal regulations.
21 CFR Part 11 typically applies to biotechnology, pharmaceutical, medical device, biotech, biologics, and other FDA regulated industries. Signatures are required on 21 CFR Part 11 electronic records such as info on: signer name, date and time of the signature, and meaning of the signature. This serves as a timestamp recorded by the CFR Part 11 compliance software.
In addition, the FDA suggests that you have an audit trail to make sure that your electronic records are accurate. This will also help you to be certain that no one else has accessed your records without your permission. You should also maintain copies of your Title 21 CFR Part 11 records in a common format such as XML as recommended by the FDA. This will help you to maintain your own set of records so that you can verify the accuracy of them in case there are any inaccuracies or errors in your records; or there is a federal audit.
The most important thing is that the predicate rule requirements are followed. These are designed to restrict access and to maintain integrity of electronic records so that there are no issues in that regard. Thankfully, all of these objectives can be accomplished with the right CFR Part 11 compliance software from ValuTrack. You can therefore have certainty in knowing that your records are accurate.
You also want to keep your records accurate enough to comply with the FDA requirements, but you do not want to spend too much money on complying with these regulations. Thus, the right CFR Part 11 compliance software is necessary so that you can strike the right balance between complying with regulations and running a profitable business.
Maintaining accurate records and complying with federal regulations should not be too involved with the right software; in fact it can be quite simple as you have all of your records stored on your computer, right in front of you.
ValuTrack’s CFR Part 11 Compliance Software can help ensure integrity of electronic records. You do not want to have the FDA make a visit and determine that you have inaccurate records. You want to make sure that all necessary timestamps are up to date and that only the people whom are allowed to access your records can access them.
For more information and benefits of 21 CFR part 11 compliance software visit www.ValuTrack.com
KJ Steinhoff – firstname.lastname@example.org
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