Adobe Acrobat Sign Validation
Accelerate the Validation of Adobe Acrobat Sign
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.
An Experienced In-House Validation Team
Montrium’s Professional Services division provides expert consulting services related to cloud compliance and computer system validation. We have assisted numerous life science organizations by developing and executing a comprehensive validation strategy of several GxP cloud-based platforms and applications including Adobe Acrobat Sign. Together with internal process owners and system managers, our validation experts work to ensure Adobe Acrobat Sign is properly configured and maintained in a controlled state by executing the Validation Template Pack.
Efficiency without compromise on Compliance
Montrium has produced a series of Validation Document Templates for Adobe to accelerate the validation of Adobe Acrobat 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 Acrobat Sign.
Our Approach to Adobe Acrobat Sign Validation
Building the Foundation for GxP e-Signatures
PHASE 1
Business Analysis
PHASE 2
Configuration
PHASE 3
Validation Execution and Reporting
Business Analysis
Validation Planning – In accordance with ISPE’s GAMP®5 risk-based framework, we begin by producing a plan to define the validation approach, activities, responsibilities, and deliverables for the validation of Adobe Acrobat Sign.
Regulatory Impact Assessment – We assess the regulatory impact of using Adobe Acrobat Sign for electronic and digital signatures in the context of GxP regulated activities. The technical features and procedural controls required for the system to comply with 21 CFR Part 11 are also identified.
System Requirements – Within the context of your business processes, we make sure that requirements for electronic signatures management are defined and risk mitigation activities are accounted for. We couple this with a description of the built-in Adobe Acrobat Sign functionality that satisfies the requirements
Configuration
Configuration of Controls & Settings – The organization’s Adobe Acrobat Sign Account is configured so that the system can be used in a way that complies with 21 CFR Part 11 requirements. Montrium and Adobe experts closely collaborate to onboard customer specialists and technical SMEs, providing the quickest time to value with Adobe Acrobat Sign meanwhile ensuring compliance.
Validation Execution and Reporting
System Setup Verification – We define the test strategy, procedures, documentation, and acceptance criteria that will be used in the verification of Adobe Acrobat Sign. Executed test scripts provide documented evidence that Adobe Acrobat Sign is configured correctly and operates as intended.
Establish Traceability – We demonstrate the relationship between the requirements and any relevant controls that have been implemented by the customer and Adobe (e.g. qualification testing, procedural controls, audits/assessments, and contractual agreements).
Validation Summary Report – This report summarizes the entire validation exercise for Adobe Acrobat Sign, including the outcome of validation activities and a statement of fitness for intended use.
Speak to an expert today
Find out how Montrium’s Adobe Acrobat Sign Validation Pack can help you on your journey to validating Adobe Acrobat Sign