Memmert CELSIUS 10 FDA - Manual (Page 10)

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CELSIUS 10 FDA-Edition
2.1.2 Advanced FDA Edition functions
Within a closed system this specially developed software meets the FDA requirements. The
Food and Drug Administration as the USA regulatory authority is responsible for monitoring
manufacturing processes in the food, chemical and pharmaceutical industries.
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User management in user groups by the administrator
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Storage of profile and protocol data in file format secure against falsification
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Monitoring of log on/off procedures, alteration of the raw data with the aid of an audit
trail
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Complete integration into the Windows NT, 2000, or XP Professional security system (au-
thority management, user and password management, user authentification)
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Facility for data export in generally readable HTML
21 CFR Part 11
The regulation 21 CFR (Code of Federal Regulation) Part 11 came into force in 1997. It
describes the requirements of the American health authority FDA (Food and Drug Administra-
tion) in respect of electronic data sets and signatures so that they can be used as replacement
for extensive paper documents and manual signatures. The initiative for their development
came from the pharmaceutical industry. It applies to all enterprises in pharmacy, biotechnol-
ogy and medical technology which manufacture in the USA or supply to the USA.
Manufacturers of FDA-regulated products, especially of pharmaceutical and chemical prod-
ucts, are subject to strict validation duty. The USA regulatory authority prescribes a continuous
documentation and long-term archivation of the process variables.
The regulation applies to all production and quality assurance documents which previously
had to be presented on paper and signed. These documents can in future be generated,
stored and signed electronically.
They are filed in:
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Electronic Records
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Audit Trails
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electronic signatures (Definitions see page 3 )
The FDA conform software “CELSIUS FDA-Edition“ meets the requirements for the use of elec-
tronically stored data sets and electronic signatures as laid down in the directive 21 CFR Part
11 of the US Food and Drug Administration (FDA) :
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Authenticity: user and administrator of Electronic Records must be uniquely identifiable
and authentic.
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Integrity: the data of Electronic Records must permit unique inference to the processes
documented. All alterations must be documented long-term over the course of the archi-
vation period.
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Undeniability: the Electronic Signature inseparably linked to the data set must uniquely
identify the responsible originator
• Unique identification of the user
• User-related access protection for individual system functions
• Security of data against falsification
• Automatically operating audit trail with time stamp, signature, and type of alteration
on the Electronic Records
• Facility for human and electronic reading and copying of the Electronic Records
• Facility for access to the data by inspectors of the regulatory authorities