The Food and Drug Administration (FDA) in the United States and the American Society of Mechanical Engineers both have standards to help ensure that design and manufacturing companies can use electronic records and signatures that are equivalent to those based on paper and ink. However, initiating and maintaining ASME Y14.42 and 21 CFR Part 11 compliance can be complex, time consuming and costly. Visidian Connect simplifies compliance with support for the complete product lifecycle and support documents lifecycle by providing the following:
- A digital approval system protected with a security system that protects both the system and and data from unauthorized access or changes.
- All printouts of digital drawings contain status and approval indicators.
- Dual Password security providing the necessary integrity and ability to authenticate the signature(s) such that the signature(s) cannot be repudiated.
- A system of authentication to ensure the accuracy of the approval indicator.
- Revisions to drawings and associated documents require appropriate approvals.