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Last update: March 12, 2026
As organizations move away from wet‑ink signatures, many life science teams are adopting electronic signature solutions to improve efficiency while maintaining compliance. Adobe Acrobat Sign is a leading option, offering configurable controls, robust security features, and strong collaboration capabilities.
However, before Adobe Acrobat Sign can be used within a GxP regulated environment, there’s one big step you’ll need to complete to ensure you are 21 CFR Part 11 compliant - Validation.
To support this effort, we have developed a clear, step by step roadmap to help organizations validate Adobe Acrobat Sign quickly and effectively for 21 CFR Part 11 compliance.
Why you need to validate
You may wonder why you need to validate Adobe Acrobat Sign at all. It may seem like an unnecessary compliance burden with Adobe being a reputable and trusted software provider. But the truth is, validation isn’t just a “nice to have”- it’s a regulatory obligation.
Under 21 CFR Part 11, any system used for electronic records or signatures must be validated to demonstrate that it functions as intended and meet the applicable regulatory requirements.
The responsibility for validation lies with the organization using the system, not the software service provider. Validation provides documented evidence that the system is fit for its intended use within your specific regulated context.
Choosing a risk-based validation approach
Traditional validation methodologies often involve comprehensive and exhaustive testing of system functionality. While thorough, this approach is often resource-intensive and inefficient, without necessarily improving the level of assurance that the system is fit for intended use.
As a result, many organizations are adopting a risk-based validation approach, in which the scope, rigor, and extent of validation activities are scaled proportionately to the level of risk that the system’s use poses to patient safety and rights, product quality, or data integrity.
A risk-based validation framework enables a more focused and efficient allocation of resources by prioritizing functionality that has direct or significant impact on regulated processes.
Under a risk-based validation framework, organizations can:
- Avoid over-testing aesthetic or non-critical features.
- Leverage vendor-supplied documentation and materials, when suitable, to reduce unnecessary duplication of testing.
- Use less formal testing techniques (such as unscripted or exploratory testing) for lower-risk functionality.
This approach is consistent with current industry best practices, including ISPE’s GAMP® 5, and is particularly well suited for systems such as Adobe Acrobat Sign, which typically presents a relatively lower risk profile compared to some clinical or medical device systems.
The foundational pillars of validation
To meet the standards set by regulators, we recommend structuring your Adobe Acrobat Sign validation process around three foundational pillars.
1. Vendor qualification
Vendor qualification is more than just “choosing a supplier”. It’s a compliance-driven process of evaluating and approving a supplier to ensure they are capable of meeting your organization’s quality, security, and regulatory requirements.
You should evaluate Adobe’s competence and reliability as a cloud service provider, ideally before you begin working with them. This involves understanding which regulatory responsibilities remain with Adobe and how they fulfill their obligations.
Get started by reviewing this Adobe Acrobat Sign Validation paper outlining the shared responsibility model between your organization and Adobe.
2. System setup and validation
After onboarding with Adobe, you will need to configure your instance of Adobe Acrobat Sign with the appropriate settings to support 21 CFR Part 11 compliant signatures. Once configured, you will need to demonstrate - and document - that Acrobat Sign operates as intended within your specific context of use.
If you want to get a jump start on this, we recommend looking at the templates provided in the Adobe Acrobat Sign validation template package (it’s free!). The package was designed to align with the risk-based validation approach for a configured software as described in ISPE’s GAMP® 5.
3. Procedural controls
Setting up your Adobe Acrobat Sign environment alone is not enough to be 21 CFR Part 11 compliant. Organizations must also establish procedural controls (such as SOPs and policies) that govern system use, administration, user access management and ongoing compliance.
Project roles
A successful validation effort typically involves collaboration across several roles:
- Process Owner – This role is the voice of the end-user. They ensure the system meets their business process needs.
- System Owner – Often part of IT, this role represents the administrative users. They manage system configuration, administration, and user access.
- Quality – This role has oversight over the entire validation process. They ensure that vendor assessments, validation deliverables, and SOPs comply with your organization’s quality standards and regulatory expectations.
Active participation across these roles is essential to maintaining a defensible validation state.
Support from Adobe
To strengthen their service offering for life science organizations and make the validation effort as effective and efficient as possible, Adobe collaborates with Montrium to offer the Adobe Acrobat Sign validation template package for enterprise customers.
This package includes templates for the following validation deliverables:
- Validation Plan
- Regulatory Impact Assessment
- System Requirements Specification
- Validation Test Protocol and Test Scripts
- Work Instructions
- Requirements Traceability Matrix
- Validation Summary Report
These templates can be tailored to your organization’s needs and are designed to significantly accelerate your validation activities.
In addition, Executed Test Records are provided, documenting the results of testing for standard and exception use cases for 21 CFR Part 11 compliant electronic signatures. After assessing the suitability of the test results (including confirmation of appropriate use case coverage), you may choose to leverage some or all of the Executed Test Records as objective evidence that Acrobat Sign performs as intended.
8 steps to achieving 21 CFR Part 11 compliance
Step 1: Qualify the vendor (Adobe)
Following your standard vendor management procedures, conduct you own assessment of Adobe to confirm Adobe’s controls and overall compliance posture.
You could try to qualify Adobe as a vendor through one of the three common approaches - a basic assessment, an assessment questionnaire, or an on-site audit - but each of these methods present different challenges and complexities.
If you want to avoid the hassle and burden of conducting the assessment yourself, we recommend taking a look at Montrium's Continuous Validation Service. It includes a boilerplate Vendor Assessment designed to streamline vendor qualification efforts.
The assessment is based on a review of Adobe’s SOC 2 Type 2 report and ISO certifications, which are available from Adobe’s Trust Center.
Step 2: Onboard with Adobe
To meet 21 CFR Part 11 requirements, you’ll need to ensure that you are using the correct Adobe product. Specifically, Adobe Acrobat Sign Solutions should be used. This is a distinct software product from the standard Adobe Acrobat Reader.
When speaking to your Adobe representative, let them know that you require a subscription tier that allows administrators to enable and configure Bio‑Pharma Settings.
Step 3: Plan your validation strategy
Begin by gathering detailed knowledge about the business processes that will rely on the system and use this understanding as a basis for defining your user requirements. With your context of use in mind, identify the significant risks and determine your organization’s risk tolerance. Within the framework of your organization’s internal validation policies, establish an appropriate risk-based validation strategy and test plan.
If you intend on following a conservative validation approach and plan on allocating resources to test your instance of Acrobat Sign, consider using the Adobe Acrobat Sign validation template package as your starting point.
If you prefer a streamlined validation approach that leverages vendor-supplied test documentation, consider using Montrium's Continuous Validation Service. Our approach supports the use of Executed Test Records, helping you avoid unnecessary duplication of testing efforts.
Step 4: Configure your instance of Adobe Acrobat Sign
While the Bio‑Pharma Settings alone are insufficient to satisfy all 21 CFR Part 11 requirements, they are necessary for enforcing identity authentication at the time of signing and for ensuring that the signature manifestation consistently prints the name of the signer, the date and time of signature, and the reason for signature.
It's important to understand the full range of features available in Acrobat Sign so that you can make informed decisions about your system configuration. This paper provides a helpful overview of how to implement Acrobat Sign functionality to support 21 CFR Part 11 compliance.
Be sure to align your system configuration with your specific context of use. Enable the functionality needed for your intended use and disable any features that are not required for your business processes.
Step 5: Validate your instance of Adobe Acrobat Sign
Follow your test plan and execute testing on your configured instance of Acrobat Sign. You may choose to perform several types of testing. Configuration verification allows you to inspect your environment and ensure that system settings have been applied correctly. Functional testing allows you to verify different key functionality and use cases, and in many cases, this may overlap with user acceptance testing.
There is no “right amount” of testing - as long as your activities provide you with adequate assurance that your configured environment is fit for its intended use.
Regardless of the approach you take, the outcome of your testing activities should be documented. If you choose to leverage vendor-supplied test documentation, your rationale and decision to do so should be clearly documented.
Step 6: Establish SOPs
Validating the system is only one step in achieving 21 CFR Part 11 compliance. Full compliance requires more than just implementing technical controls or system functionality.
Your organization must also establish procedural controls (such as Policies, Standard Operating Procedures (SOPs), or Work Instructions) that ensure the system is used and maintained in a controlled, consistent, and compliant manner.
Procedural controls should cover a range of topics, including:
- System use
- System administration
- User access management
- Change and configuration management
- Supporting processes, such as training management, record retention, vendor management
If you need support for developing SOPs, consider using Montrium's Continuous Validation Service, which provides templates for procedures that govern the consistent, authorized and 21 CFR Part 11 compliant use of electronic signatures.
Step 7: System acceptance and release
Give yourself credit for all the work you’ve completed! Within the framework of your organization’s internal validation policies, you should produce a validation report summarizing the activities you performed and any material you leveraged from the vendor.
This report should include a statement attesting that the system is fit for its intended use, and this should be approved by the relevant stakeholders (at a minimum, the Process Owner and Quality roles).
This documentation serves as your formal record of system validation – which should be retained and readily retrievable for inspection.
Once released, users can be trained and onboarded in the system.
Step 8: Maintain the validated state and ongoing compliance
Once your system is validated and released, maintaining the validated state becomes an ongoing lifecycle responsibility that comes with unique challenges.
System changes may arise from user requests or from updates released periodically by the cloud service provider. Your organization should implement and follow a formal process to assess the impact of these changes and to determine whether they require any regression testing or revalidation.
Ongoing vendor oversight is important to ensure that the quality and reliability of Adobe’s service do not deteriorate over time.
Compliance also depends heavily on proper control of user access and permissions. Your organization should implement and follow a formal process to ensure system access is granted only to authorized individuals and that user permissions are reviewed on a periodic basis.
New users should be trained before being granted access, and training records should be maintained as evidence of competency.
Continuous validation support from Montrium
Montrium’s Continuous Validation Service provides life science organizations with the essential deliverables and experience needed to execute a streamlined, risk‑based validation for Adobe Acrobat Sign. Our proven and efficient approach is designed to leverage Executed Test Records to the greatest possible extent – so you spend less time testing.
The service includes a comprehensive set of document templates designed to help you prepare your initial validation package for Adobe Acrobat Sign.
What you get:
- A framework for Vendor Qualification
- A Compliance Assessment Report, where we break down 21 CFR Part 11 requirements, assign responsibilities for compliance, and use Adobe’s SOC 2 Type 2 report to confirm Adobe’s controls effectively meet their obligations.
- A Vendor Assessment Form, to capture the outcome of the assessment and to approve Adobe as a vendor.
- A framework for an accelerated Validation project
- A combined System Requirements Specification document, detailing requirements, functional specifications, and configuration specifications.
- A combined Validation Protocol and Report, describing the risk-based validation approach, configuration verification and UAT test scripts, a traceability matrix (mapping to vendor-executed testing and any testing you performed), and a summary of results.
- An SOP for the acceptable and compliant use of electronic signatures, including a sample employee identification and non-repudiation form and a sample letter of certification to the U.S. FDA.
The service includes a block of hours with Montrium’s subject matter experts, who will work with you to help you complete the initial implementation and validation as efficiently as possible - often in under 30 days.
Once you have completed the initial validation, the support continues. Montrium’s subject matter experts will monitor the changes introduced by Adobe in each major release of Acrobat Sign and assess the impact the validated state of your system.
As needed, impact remediation activities will be recommended and implemented to help you maintain continuous compliance.
The takeaway
The validation of Adobe Acrobat Sign is not a one-time activity. It is a structured, ongoing process that spans vendor qualification, thoughtful planning, careful system configuration, testing, rigorous procedural controls, and continuous oversight.
By following this roadmap, you create a defensible validation framework – with documented evidence - that supports both compliance and operational excellence.
Montrium’s validation materials and Continuous Validation Service are purposefully designed to reduce effort, accelerate timelines, and help your organization implement a fully compliant 21 CFR Part 11 electronic signature solution.
Not ready to take our word for it? Have a look at how we helped Pharmascience save two months of work while validating Adobe Acrobat Sign.
If you have any questions about the Montrium's Continuous Validation Service, you can reach out the Montrium team directly and we'll be more than happy to help!
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