Re: Digital Signature Solutions
If you Google - Digital Signature Solution regulated environment - a list of companies comes up. The only one I've had recent experience with is Documentum, which was so highly customized for the company using it that it was ridiculous, and was a pain to validate, especially when updates were made to the core Documentum software. In this company, many projects spanned several facilities across several countries and/or states, so there were numerous signatories, and they were faxed/emailed to the main project site.
The biggest issue with any software used for documents in a regulated environment is that you have to ensure it meets the regulations for document control and you have to validate it. That can sometimes be more of a headache than scanning pdfs for signatures. Lots of companies don't have the time, budget or people to put together a project team and do all the documents and work required for a validation, or they don't see the need to do it, yet the FDA states:
"Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR ?820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system."
http://www.fda.gov/medicaldevices/d...guidancedocuments/ucm085281.htm#_Toc517237933