Dear RA Community,
I am seeking reputable resources/examples that I can access to help guide the development of global policies and procedures related to electronic batch records (for example, lifecycle management including creation, approval, issuance, use, review, and archival). The documents will align with CFRs, but I would be thrilled to review additional information to supplement the authoring of these documents.
Might someone from the community be able to point me in the right direction for helpful information or resources in this area?
With appreciation,
Kristen Picard, PhD
Consultant
Boston, Massachusetts
United States