Printable Version of Policy
Adopted: October 13, 2009
The purpose of this policy is to confirm Washington University’s commitment to conducting business in compliance with all applicable laws, regulations and University Policies. This policy outlines the technical measures required to insure appropriate signatures are assigned to electronic information and related material and to protect from unauthorized use.
In addition, the FDA requires that electronic records and signatures be maintained in accordance with the FDA regulations relevant to the safety and integrity of study data under regulation, 21 CRF Part 11. This regulation has an increasing impact on Washington University School of Medicine since the majority of our patient records are maintained electronically.
1. The term electronic signature means a signature in electronic format, attached to or logically associated with an electronic record.
2. The University considers electronic signatures to be legally binding and the equivalent to a handwritten signature. University employees will only utilize electronic signatures for appropriate business purposes. In addition, employees are accountable for all actions initiated under their electronic signature. Falsification of records or signatures may be subject to disciplinary action. Employees are required to report any suspected or fraudulent use of signatures immediately.
Several legislative requirements impact the use of electronic signatures. Additional information can be found at http://www.edfoundation.org/ElectronicSignaturePolicy.htm. The following legislation impacts the use of electronic signatures.