NovaGMP

The NovaGMP module of NovaManage is designed to meet the specific requirements of highly regulated industries for strict control of electronic signatures, renditioning and printing. It enables user organisations to comply with FDA regulation 21 CFR Part 11. 

Renditioning enables Microsoft Word documents to be converted and stored in both native and PDF (Portable Document File) acceptable formats. PDF allows searching of documents for key words and phrases and is readable across many platforms, but prevents change to the content of documents.

Electronic Signature Capture and Manifestation allows tamperproof verification that the right people have reviewed and approved information. As a document goes through an approval process, the workflow stores electronic signatures and other related information about the document and the approval process. When the document is released this signature history is merged into the released document, where it can be read and printed.

Controlled Printing allows the status of all hard copy output to be included in the print as a banner or watermark. Users can clearly see if they have a draft or uncontrolled copy of a document, as well as other document information such as who printed the document and when. Access to print functions is strictly controlled and audited, so users can be notified when new version of documents have been released.