Memmert AtmoCONTROL FDA Version 2.X.X - Manual (Page 9)

D30396 | Date 09/2014 9
AtmoCONTROL FDA Version
2.3 Advanced functions of the AtmoCONTROL FDA version
Within a closed system, this specially developed software meets the requirements of the Food
and Drug Administration (FDA). The FDA is the US agency responsible for monitoring produc-
tion processes in the food, chemical and pharmaceutical industry:
►
User management by the administrator
►
Storage of profile and protocol data in a file format that cannot be manipulated
►
Monitoring of login and logout processes and of alterations of the raw data using an audit
trail
►
Possibility of data export to generally readable HTML format
21 CFR Part 11
The regulation 21 CFR (Code of Federal Regulation) part 11 came into force in 1997. It
describes the American Food and Drug Administration’s (FDA) requirements for electronic
records and electronic signatures for their use instead of elaborate paper documentation and
handwritten signatures. The stimulus for its creation came from the pharmaceutical industry.
It applies to all companies in pharmaceutics, biotechnology and medical technology produc-
ing in the US or shipping to the US.
Manufacturers of FDA-regulated products, in particular of pharmaceutical and chemical prod-
ucts, are under a strict validation obligation. The US agency stipulates continuous documenta-
tion and long-term archiving of the process variables.
The regulation applies to all production and quality assurance documents that had to be pro-
vided signed in paper form before. These documents may as of now be created, stored and
signed electronically.
They are stored in:
►
Electronic records
►
Audit trails
►
Electronic signatures
The FDA compliant software AtmoCONTROL FDA edition fulfils the requirements for the use of
electronically stored datasets and electronic signatures defined in regulation 21 CFR part 11 by
the US Food and Drug Administration (FDA):
►
Authenticity: The users and administrators of electronic records must be uniquely identifi-
able and authentic.
►
Integrity: The data of electronic records have to allow unique inferences about the process-
es documented by them. Any modifications must be continuously documented through-
out the archiving period.
►
Non-repudiation: The electronic signature, inseparably connected to the electronic record,
must uniquely identify the author responsible
•
Unique identification of the user
•
User-related access protection for individual system functions
• Safety of data against manipulation
• Automatic audit-trailing with timestamp, signature and type of modification to the
electronic records
• Human readability and machine readability of electronic records
• Access option to data for the inspectors of regulatory authorities