Barriers to Implementing Electronic Signatures

April, 2004

Software vendors who serve FDA regulated industries like to promote their support for electronic signatures. But I’m starting to think that it will take a lot more than good software to make electronic signatures work. It seems that, even when software supports electronic signatures, many users don’t implement them.

Although I’ve been noticing this problem for some time, it finally became clear to me earlier this week. I gave a presentation on electronic records and signatures at the IFS World conference. After the presentation, I got into a discussion with a user from one company that has implemented IFS Applications in the medical device industry. The company has been quite successful generally with its use of the system. Nevertheless, the firm has still not implemented electronic signatures.

The problem is not IFS functionality. IFS has good support for electronic signatures and is even working on adding an option for biometric signatures to its product offering. The problem, according to this user, is the business processes themselves that involve approvals.

For example, this user pointed to the process of transferring a new product design from engineering to production. This is a key control point in FDA’s quality system regulation, which requires formal sign-offs when design changes are transferred to production. This company does have the required approval steps. But, the paperwork flow from approver to approver is not disciplined. One approver may sign off on the design and forward it to the next individual on the sign off list. The second individual may not have reviewed all the paperwork in advance and now finally takes a good look at it and finds some issue. He marks up the design and sends it back to the initiator for re-routing. Multiply this several times for several approvers and you can see the problem. I suppose it is possible to automate such a process with electronic workflow and electronic signatures, but it would likely bog down with all the re-initiation of signatures and re-routing.

A better approach would be to improve the organizational disciplines around the approval process itself. The company should strengthen its practice of design reviews so that all approvers review the design and raise any issues or questions prior to the design transfer process being initiated. Then, when the design transfer process is initiated, there should be few if any surprises.

The problem therefore, is not whether the software has electronic signature and workflow routing capabilities. Many of the major vendors now have this functionality. The problem is that the business process to be automated need to be formalized to the extent that they can use the functionality.

April 2004