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This document describes the approach, roles and responsibilities, and deliverables that comprise the customer’s Adobe Acrobat Sign validation effort.
This document is used to assess the regulatory impact of using Adobe Acrobat Sign for the application of electronic signatures to electronic records. Technical and procedural controls required for system conformance with 21 CFR Part 11 regulations are identified.
This document combines different levels of specifications. Requirement Specifications outline business (end user), functional, security, and regulatory requirements. Functional Specifications describe the system functions and features needed to meet the specified requirements. Configuration Specifications describe how the system must be configured to meet the specified requirements.
This document provides a framework that governs the verification and testing that will produce documented and objective evidence that Adobe Acrobat Sign has been configured correctly and operates as intended (in accordance with specified requirements). The protocol oversees the execution of test scripts, which include instructions for verification of the configuration of the system and for functional testing.
As part of the quarterly Adobe Acrobat Sign release process, test scripts from the validation package are executed by Montrium. For testing purposes, Montrium configured an Adobe Acrobat Sign account in a manner that is consistent with the recommended configuration as defined in the Configuration Specifications. The test results are provided as-is and customers may choose to leverage them as part of their validation strategy, as appropriate.
This work instruction describes Adobe Acrobat Sign (Adobe Sign) account administration activities and establishes a process for the application of electronic signatures.
All standard Adobe Acrobat Sign documentation packs are available for free to Adobe Acrobat Sign customers.
The document templates contained within the complimentary validation pack are designed to help GxP-regulated customers accelerate the validation of Adobe Acrobat Sign in the context of 21 CFR Part 11 regulations. The templates are provided as-is and are designed to be adapted, as necessary, by GxP-regulated customers. Templates are updated periodically in conjunction with the Adobe Acrobat Sign release schedule.
More and more, life science organizations are looking to leverage cloud-based e-signature solutions in order to remove their dependence on traditional paper-and-ink signatures.
As a leading application that facilitates a GxP regulated process, Adobe Acrobat Sign helps teams deliver verified and trusted electronic and digital signatures anywhere, on any device. Most importantly, Adobe Acrobat Sign has been built with the necessary technical features and the procedural controls to allow life science organizations to comply with the FDA’s 21 CFR Part 11.
Montrium provides an accelerator toolkit that is designed to streamline the validation of Adobe Acrobat Sign to days, not months. Implement compliant electronic signatures as well as the technical and procedural controls you require to comply with the regulatory requirements.
We’ve co-authored a white paper with Adobe to help life science customers map out their validation requirements for electronic signatures and the Adobe Acrobat Sign product. If you're looking to apply compliant electronic signatures and you're working in a GxP environment, this is a must-read.