Signature Authentication

Transcription

1 Signature Authentication aka: How to stop chasing after your clinical staff for signatures Elizabeth Nista, CQIA

2 The Written Signature as a Validation Tool Signature is a requirement of multiple accrediting bodies Needed for internal and external written agreements, audits, validations, SOPs, orders, and consents

3 The Written Signature as a Validation Tool Difficult to get in an efficient manner Must wait for the document to be reviewed and approved Have to keep checking back to determine if signed If multiple signatures are required you must pick up, verify signature and date, and deliver multiple times Difficult to verify Is the signature and/or date authentic? Easy to forge or back -date

4 The Written Signature as a Validation Tool An Adobe digital signature was implemented. This is an easily accessible program through Adobe. The change, with instructions, was communicated to staff through a mass . Our accrediting and overseeing bodies (FACT/AABB/CIBMTR/IRB/FDA etc) were consulted and it was determined this was not only an acceptable, but a preferable format

5 Creating a Digital ID A digital ID can be easily verified. Not all electronic signatures are digital signatures. A digital signature ensures that the document is authentic and was not altered. It contains encrypted information unique to the signer. You can determine almost all aspects of your digital signature s appearance Any document can be signed more than once and by more than one person Non-repudiation, or more specifically, anyone that has signed using a digital ID cannot at a later time deny having signed it.

6 The signature consists of 3 components, each of which are optional and can be customized The signature Signature details (e.g. address, business location, reason for signature) A watermark

7 You can set the appearance of your digital signature by selecting options in security preferences By using this option you can include an image of your actual handwritten signature, a company logo or a photograph simply by uploading from your desktop

8 Implementation After a final review, the document to be signed must be converted to a PDF format This format ensures that the information contained has not been altered. The document is then ed to the parties for final review If acceptable the signator then applies their electronic signature and electronically returns the document Each signer creates an electronic signature, also called a Digital ID, in Acrobat Each signature includes the real time and date that the signature was applied This makes back dating documents nearly impossible The electronic signature uses encryption technology to verify the signer s digital identity

9 BE AWARE! You cannot recover a lost password An entirely new Digital ID must be created if the password is lost.

10 Conclusion Workflow was dramatically improved Signatures were now as easy as answering an . Papers were never lost, misplaced or moved to the bottom of the pile! Staff appreciated the increased flexibility. Additional staff were included in the signature page due to the ease of use Signatures, and consequently all internal documents, benefited from increased integrity and authenticity Inspectors, staff, and auditors could be assured of viewing the most current, authentic, version of any document

11 Conclusion Additional documents are now signed due to ease of use and additional staff are included in the review process: Meeting minutes Audits and validations SOPs All Quality documents, including Quality Plans

12 Conclusion At our last FACT inspection we were given high marks for this process The date stamp makes an obvious trail that cannot be modified or altered All parties are now included and asked to verify agreement by signature

13 QUESTIONS? Feel free to me with any questions at You can easily upload all directions at the Adobe website.