Adobe Sign can automate the signing process for life science companies to alleviate current business compliance challenges and bottlenecks. With built-in controls and processes, electronic and digital signatures can be deployed while complying with GxP requirements, including FDA 21 CFR Part 11.
By moving away from manual paper-and-pen signatures, life science organizations benefit from the optimization of GxP processes, a convenient signing experience anywhere and on any device, a boost in efficiency, shorter project timelines, reduced cost of clinical development, and minimized risk by enabling a GxP regulated process.
In Montrium’s April 2020 webinar “How to Leverage Adobe Sign for Remote 21 CFR Part 11 e-Signatures”, over 46% of attendees said they were looking to implement the solution, while 16% said they were already using the solution for both GxP and non-GxP purposes.
Adobe Sign is a cloud-based system that is delivered to customers via a SaaS delivery model, and while Adobe is responsible for ensuring the quality of the application, customers must ensure the application is configured accordingly for GxP purposes. This infographic provides the fundamental guidance that Adobe Sign life science customers will need to implement Adobe Sign and benefit from compliant e-signatures as quickly as possible.
About Montrium’s Adobe Validation Services
Montrium’s Professional Services division provides expert consulting services related to cloud compliance and computer system validation. Montrium has produced a series of Validation Document Templates for Adobe to accelerate the validation of Adobe Sign and establish compliance with 21 CFR Part 11.
Our services make it possible to adapt each template to your organization’s unique requirements (e.g. Standard Operating Procedures, protocols) and prepare validation deliverables as part of a built-in framework for producing GxP signatures and records with Adobe Sign. Together with internal process owners and system managers, our validation experts work to ensure Adobe Sign is properly configured and maintained in a controlled state by executing the Adobe Sign Validation Pack.
