The need for pharmaceutical laboratories to comply with Title 21 of the Code of Federal Regulations Part 11 is an increasingly important issue.
The need for pharmaceutical laboratories to comply with Title 21 of the Code of Federal Regulations Part 11 is an increasingly important issue.
It generates many requests for "21 CFR Part 11 compliant" software, despite the fact it is the laboratory that has to be in compliance with the regulations, rather than the software.
To be compliant the laboratory often requests support from its software supplier.
Radiometer Analytical now offers a special FDA 21 CFR Part 11 compliant version of its titration PC software.
The TitraMaster 85 Data Collector automatically handles and archives data from connected titration workstations performing end-point, potentiometric or pH-Stat titrations into an extensive results storage database. Database security is ensured by the use of encrypted passwords as well as the provision of protected access and authorisation levels including 4 levels of user profile.
Records are accompanied by a full set of data to ensure traceability.
There is no risk of records being falsified or deleted. Operator-friendly features include live display of results including curves and special calculations.
The software includes an "audit trail" which chronologically tracks and records all operations performed within the database with a clear-text description.
Signed records can be exported to Excel in files which are protected from further changes by a randomly generated password.
Along with the many built-in checks and assistance that are within the titration workstation itself, TitraLab in conjunction with TitraMaster 85 makes the handling of electronic records of titration data according to FDA requirements simple, safe and efficient.
