iGC-SEA supports 21CFR Part 11

Code of Federal Regulations Title 21 – FDA or the 21 CFR Part 11 is a necessary requirement to record or document manufacturing activities, mainly in Pharmaceutical and Food industries.

iGC-SEA now supports 21 CFR Part 11. iGC-SEA is based on Inverse Gas Chromatography (iGC) methodology and is a gas phase technique for characterising surface and bulk properties of solid materials. It is a second generation iGC instrument and the world’s only commercial instrument. (Read here to know more about the system)

21CFR Part 11

With the release of 21 CFR Part 11 in 1997, the FDA specified its requirements for accepting electronic records in lieu of paper records. It is beneficial in future to design a discovery automation system to comply with Part 11 because the FDA may decide in the future to further codify the requirements for drug discovery records. If it does so, it is likely that the requirements will follow the same standards as Part 11. 

Goals behind CFR 21 Part 11

All experimental protocols are clearly documented and identified

Only authorized personnel can access the system

Information can be viewed in either electronic or human-readable format and that records be available “in a timely fashion”

Time of information entry and of any modification is noted

Using CFR 21 Part 11

Compliance with Part 11 will ensure that you have full support for patents. You will be able to supply exact records supporting any filing or later patent dispute. The principal investigator, time of discovery, and methodology will be identified beyond doubt.

It is a codification of good laboratory practice (GLP) – it is also a set of guidelines for improving the security and efficiency of your discovery-stage workflow.

Requirement for QC and QA processes

For more information regarding CFR and iGC-SEA, please email [email protected]

Related links: