Wednesday, September 18, 2019
 
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Work in compliance to GLP / GMP / FDA 21 CFR Part 11

Statutory duties easily fulfilled

With WinControl you can work in compliance with GLP/GMP and FDA 21 CFR Part 11.
We provide:

  • Assistance in getting suitable software.
  • Statements for vendor qualification.
  • Comprehensive IQ/OQ Example-documents for validation.
  • E-mail support on any other question.

 

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Example: CFR 21 Part 11 of the Food and Drug Administration (FDA)
Example: Validation for CFR 21 Part 11 of the FDA

Companies, particularly in the pharmaceutical or medical sector, often have to abide by many regulations and guidelines. One of the most important rules - the CFR 21 - is defined by the "Food and Drug Administration" (FDA).

The "CFR 21 Part 11" determines basic requirements to electronical documents in the pharmaceutical or medical industry, which can be generated by use of ALMEMO measuring devices and the software AMR WinControl.

To facilitate your proof of compliance, we provide a Validation File for AMR WinControl, which contains sample documents to qualify the ALMEMO technology and AMR WinControl.

You simply select the applicable chapter and customize it corresponding to the specific characteristics of your system. This enables you to verify - entirely repeatable - the correct and compliant functioning of your system in accordance to "CFR 21 Part 11".


FDA 21 CFR Part 11
Password Protection & Access Rights
Event Protocol (Audit Trail)
Tamper-resistance
Alarm functions
Automatic Recording (AutoSave)
Proof of system configuration
Automatic Operation

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