eSignature usage

[carlamadigan]

Hello everyone, We are curious if any validated customers, preferably working in Pharma or other FDA-regulated industry, has turned off e-Signatures. And, would you be willing to speak to us about their decision-making, experience, repercussions, etc.

[MarikaSchuck]

Hi 

I work in the Pharma Industry and we have turned off e-Signatures. Our users just quote R&U by acknowlegement of a currently custom wrapper which is in place for our Standard Operating Procedures and or the SAP Standard Wrapper for all other trainings. As the decision was taken before I took over this role. I would need to come back to on the ration of the decision- making process. But from an end user experience it is a very positive one and we did not face any issues in audits and or inspections up to now. 

[Robert_Guglielm]

We are at Eli Lilly and did not implement e-signatures from the beginning. I was not there when the decision was made but I believe the rationale was that GMP regulations do not explicitly require e-signatures for training records. We use an electronic acknowledgment via an AICC Wrapper where the learner acknowledges they have read and understood the material, but it is not followed by an e-signature. We have had many audits and inspections over 10 years and have never had any issue with not having electronic signatures.

[carlamadigan]

Thank you, Robert for the information.  We really appreciate it.

[carlamadigan]

Hi Marika, Would you be willing to let me know what your company is?  Thanks so much.

[MarikaSchuck]

Hi, sure I work for Boehringer Ingelheim GmbH & Co. KG.