Part 11 Compliance Documentation

Hi there,
I work for a pharmacy automation company and we are in the process of implementing Epicor 10, public cloud based. A big part of our decision to select Epicor as our next ERP was that we were told they had the documentation we’d need to become 21 CFR Part 11 compliant. We specifically asked if they had documentation for IQ/OQ/PQ and it was affirmative. Now we’re a couple months into implementation, and our implementation partner has said no documentation like that exists. Today we had a call with an implementation person from Epicor who also basically said nothing like that exists for Epicor. They’re saying they don’t even have documented design requirements for the sofware… how is that possible? Now the Epicor implementation guy wasn’t the expert in 21 CFR Part 11 compliance, so I’m not sure if he really knows what he’s talking about or not. Can you guys help me understand what kind of documentation you were provided by Epicor on IQ/OQ/PQ and validation, security, accountability, nonrepudiation and Part 11? I would so appreciate the help!
Thank you so much,

Jackie I have worked with multiple medical companies developing Validation Master Plans and IQ/PQ/OQ protocols for Epicor implementations and I have never seen any Epicor provided documentation in terms of validation regarding electronic documentation or electronic signatures. Usually the requirement is to document how your company is using certain functionality in Epicor, based on your QMS procedures, and then write the protocols to match your use of Epicor, especially in the areas of traceability, manufacturing, and quality. For example you may use the authorized suppliers functionality in Epicor. It would then be up to your company to write a PQ documenting that Epicor will not allow someone to purchase a part on a PO for a vendor not authorized for that part and then execute the protocol. Other companies may use a paper based list of authorized suppliers that buyers are supposed to follow. In that case since they do not use that functionality in Epicor they do not to have it as one of their documented test cases.

Hi Mark,
Thank you for your response. Can you shoot me an email and maybe we can have a call about this and future efforts?