Compliance with GLP and CFR21 Part 11 Standards
The reliability of Peak-ABC system is evident from the growing number of happy end-users and OEM partners since we first commercially launched the software in year 2000. Peak-ABC system is designed with the GLP and CFR21 Part 11 standards in mind, so it is well fitted to the standards in following aspects:
1. Login on start up is compulsive. Different user may take different role and has different accessibilities after enter in the software.
2. The name of user who does the analysis will be recorded in the chromatogram file as an electrical signature. You can open a chromatogram file and get the name of the analyst who acquired the chromatogram.
3. Two kinds of audit trails are strictly encrypted. One is saved with the chromatogram file to record the steps how the chromatogram is processed, and the other is an independently file recording the whole system information, such as every time and name on login, injection time, run serial number, and the name of chromatogram file saved etc.
4. All-in-one structure is adopted by Peak-ABC for the purpose of thorough tracing back. When a chromatogram file is opened, not only the chromatogram and its results, but also all information about how the chromatogram and its results got are opened together. So you can see the relevant processing parameters, integration methods, calculation parameters and audit trails etc.
