Ofni Systems Inc. helps you automate the collection and distribution of information within your environment to improve your business while achieving compliance with 21 CFR Part 11, Electronic Records and Signatures. We also provide help with evaluations and training on Part 11.

The Part 11 Advisor is a program for helping you implement and manage a Part 11 Remediation Plan.  Every aspect of a Part 11 Remediation Plan is covered, from employee training and gap analysis to the generation, execution and tracking of a corrective action plan. 

The Part 11 Toolkit is a set of utilities that you can add or use in any Access database to help you achieve compliance with 21 CFR Part 11, Electronic Records and Signatures. The Toolkit can be implemented either remotely or on-site by a member of our experienced staff. Training on Part 11 Toolkit implementation is also available for organizations that would like to incorporate large numbers of the toolkit.