The document templates contained within the complimentary validation pack are designed to help GxP-regulated customers accelerate the validation of Adobe 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.
Contents of the validation package include:
This document describes the approach, roles and responsibilities, and deliverables that comprise the customer’s Adobe Sign validation effort.
2.Regulatory Impact Assessment
This document is used to assess the regulatory impact of using Adobe 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.
3.System Requirements Specification
This document combines different levels of specifications:
- Requirement Specifications, outlining business (end user), functional, security, and regulatory requirements
- Functional Specifications, describing the system functions and features needed to meet the specified requirements
- Configuration Specifications, describing how the system must be configured to meet the specified requirements
4.Validation Test Protocol (including Test Scripts)
This document provides a framework that governs the verification and testing that will produce documented and objective evidence that Adobe 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.
5.Executed Test Scripts and Summary Report
As part of the quarterly Adobe Sign release process, test scripts from the validation package are executed by Montrium. For testing purposes, Montrium configured an Adobe 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 Sign account administration activities and establishes a process for the application of electronic signatures.
7.Requirements Traceability Matrix
This document captures the relationship between specified requirements and the testing activities and/or procedures that demonstrate and ensure the requirement is satisfied.
8.Validation Summary Report
This document provides a summary of the overall validation exercise, capturing the list of deliverables produced and reporting on the test results, and concludes with a statement of fitness for the intended use.