NIRSolutions
 | NIR Solutions - An integral conceptNIRSolutions offers you - on the basis of a careful analysis of your individual problems - analytical solutions for your entire production chain, from goods reception and materials qualification to product release. |
21 CFR Part 11
Compliance with FDA 21 CFR Part 11
The actual versions of NIRCal Chemometric Software with NIRFlex Instrument Modules and NIRSearch are fully compliant with FDA 21 CFR Part 11.
It incorporates a protected database for the Audit Trail, which documents the generation, modification and deletion of electronic records. Additionally successful and failed log-ons are also tracked. Reports for qualitative and quantitative analyses can be signed electronically according to the rules. In a properly configured system the security of all electronic records is guaranteed.
Detailed information can be downloaded.
The following software products are compliant with 21 CFR Part 11:
- NIRCal 4.21
- Chemometric Software NIRFlex 4.21
- Instrument Modules NIRFlex 4.30
- Instrument Modules NIRSearch 1.0
21 CFR Part 11 Compliance Version 2.1
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Regulations
Meet strict regulations
With a NIRSolutions System you can be certain that all regulatory conditions have been met and that the results are reliable.
All BUCHI Systems and Software actively and reliably support compliance with GMP regulations and fulfill all the requirements of 21 CFR Part 11.
The latest requirements of the US Pharmacopoeia are tested and documented with help from the USP Performance Verification Kit with certified and traceable standards. The relevant form guides you
through the test as a SOP. BUCHI Specialists will conduct this test at your location and document the results, GMP compliant, as part of our service package.
If you choose NIRSolutions from BUCHI.
You receive a complete package for installation and for operation qualification.
You have the choice of conducting your own tests or instructing BUCHI Specialists to perform them.
Tests
- IQ/OQ for NIRFlex N-400/ NIRCal
- USP Test for NIRFlex N-400/ NIRCal