Database Reference
In-Depth Information
In this topic, our focus is on audit and compliance activities, so we will not expand
the manufacturing pieces. The main compliance issue is that if you are manufacturing
food, pharmaceuticals, or medical devices, you must keep records according to the
standards in CFR 21 Part 11. Electronic record keeping is available on critical business
events including:
• Approval of speciications
• Creation and approval of manufacturing samples
• Entry and evaluation of results
• Approval of stability study stages
The penalties under CFR 21 are substantial, such as $1,000,000 for any 30-day period,
where the amount doubles for every 30-day period of continued violation after the
first 30-day period. The respondent must prove any affirmative defenses and any
mitigating factors by a preponderance of the evidence.
The requirements of electronic records
We need to point out that CFR 21 Part 11 is a pretty broad set of requirements, and
many of its requirements are also part of the overall ERP system itself. For example,
Sec. 11.300 Controls for identification codes/passwords quotes, " Maintaining the
uniqueness of each combined identification code and password, such that no two
individuals have the same combination of identification code and password."
You can review the entire document at
http://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
.
As such, we are going to concentrate on the requirements that are uniquely met by
the E-records management solution. These requirements are as follows:
• Electronic records, electronic signatures, and handwritten signatures executed
to electronic records must be trustworthy, reliable, and generally equivalent to
paper records and handwritten signatures executed on paper.
• Electronic records shall contain information associated with the signing that
clearly indicates all of the following:
° The printed name of the signer
° The date and time when the signature was executed
° The meaning (such as review, approval, responsibility, or authorship)
associated with the signature
° In a human readable form of the electronic record
• This last point is more complex than it might at irst seem, because the
electronic record has to be readable at some arbitrary point in the future
when the application that created it may no longer be available.
Search WWH ::
Custom Search