Client/server system performs chromatographic instrument control, data acquisition, data processing and reporting
21 CFR Part 11 is the US Food and Drug Administration (FDA) rule relating to the use of electronic records and electronic signatures for all products sold in the United States.
Many computer systems used within the pharmaceutical and other highly regulated industries must comply.
A PerkinElmer publication describes the relevant portions of the 21 CFR Part 11 regulations and explains their implementation using TotalChrom client/server software, as well as meeting more general cGMP requirements.
The TotalChrom client/server system performs chromatographic instrument control, data acquisition, data processing and reporting.
It supports a wide range of built-in features to help FDA regulated organisations comply with requirements detailed in 21 CFR Part 11.
It combines with Microsoft Windows NT and Windows 2000 systems to provide the tools required to implement a technically compliant chromatography data system.
Proper procedures and practices are as much a part of overall compliance with these regulations as the features of the TotalChrom software.
It is the user's responsibility to implement and maintain, in a compliant manner, any data system generating electronic records.
