Software intended for the management of manufacturing processes and FDA submissions may very well be too complex, expensive, and laden with features unnecessary in your environment. Commonly available spreadsheet programs like MS Excel may really be most appropriate – but how can you create, validate and use off-the-shelf programs in your regulated environment without violating the provisions of Part 11?
FDA is well aware of the wide utility of spreadsheets, but expects the controls to be in place to ensure that spreadsheets used in GxP processes are validated and compliant with 21 CFR Part 11. In today’s environment of renewed FDA enforcement of Part 11, uncontrolled spreadsheets represent an area of increased regulatory concern and scrutiny.
You can learn to confidently harness the versatility and functionality of spreadsheets. You, your colleagues and your organization can take advantages of all of the benefits of the ease-of-use and economy spreadsheets offer – and still remain in compliance with FDA’s regulatory requirements. Key points that will be covered include:
Presented by Ofni Systems, Validation Manager, Ofni Systems
Teleconference, Presented by FOI Services