Solution provides 21 CFR Part 11 compliance controls to Excel spreadsheets by adding logical security, a secure audit trail, and the ability to apply electronic signatures
ABB has added the largest selling compliance solution for Excel spreadsheets to its portfolio of consultancy services to the pharmaceutical industry.
The software is suitable for production and laboratory systems in manufacturing, quality assurance, clinical, or R and D environments.
Wimmer Systems Dacs provides 21 CFR Part 11 compliance controls to Excel spreadsheets by adding logical security, a secure audit trail, and the ability to apply electronic signatures.
This enables controlled use and simple validation of spreadsheets, permitting the re-introduction of spreadsheets into areas where there had been pressure to withdraw their use because of regulatory concerns.
ABB was selected by Wimmer Systems to provide worldwide sales and support for Dacs because of its leading position in consultancy services to the pharmaceutical industry around the world.
ABB is already providing the Dacs software and associated consultancy and Part 11 services to some of the worlds leading pharmaceutical companies, instrument companies and third party suppliers.
ABB will supply a tailored range of installation and validation consultancy services around the product.
The full ABB/Wimmer Systems solution offers the client the benefits of a global service for fully validated spreadsheets for regulatory use.