--- title: How Academic Institutions Achieve 21 CFR Part 11 Compliance with Montrium description: See how Montrium helped an academic research institution achieve sustainable 21 CFR Part 11 compliance with governance, SOPs, validation, and training. image: https://blog.montrium.com/hubfs/Adobe%20Acrobat%20Sign_Univeristy_21%20CFR%20PART%2011.png --- [![Montrium\_Logo\_smaller](https://blog.montrium.com/hs-fs/hubfs/montrium-2023/images/logo/Montrium_Logo_smaller.png?width=130&height=32&name=Montrium_Logo_smaller.png "Montrium_Logo_smaller")](https://www.montrium.com/) ← - Products Close ## Book a live demo Schedule a demo with a representative. - ## Products Our pre-configured applications enable our clients to work better and smarter. ![63f778fbb0527c09d8b57985\_Group](https://blog.montrium.com/hubfs/montrium-2023/images/header/63f778fbb0527c09d8b57985_Group.svg) ## Book on our demo today! 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Details have been combined and anonymized to protect client confidentiality. Many universities run FDA-regulated research, from investigator-initiated studies to trials conducted with industry sponsors. When that research relies on electronic signatures, 21 CFR Part 11 applies, and the institution, not the software vendor, is accountable for compliance. A large academic research institution set out to implement an electronic signatures solution to support its regulated research. The team understood the system would need to be validated, but had concerns about the broader operational requirements of Part 11: governance, process ownership, documentation, training, and ongoing oversight. Montrium partnered with the institution to build an implementation roadmap covering both the technical and procedural sides of compliance. The result was clear ownership across departments, documented procedures, a validation approach that built on vendor test documentation, and research teams who understand their responsibilities at the moment of signature. The institution is now better prepared for inspection, with a framework it can sustain on its own.   ## **Background** ### Montrium’s Profile Montrium was founded in 2005 and has provided technological solutions for Records and Quality document management exclusively to the Life Sciences industry since its inception. Montrium also provides GxP regulatory expertise, templates, and professional services in relation to computerized system validation, compliance, auditing, and other services relevant to the Life Sciences industry. Montrium supports customers not only with validation activities, but also with establishing the governance framework (who is responsible) and the operational processes (what must be done) necessary to achieve and sustain Part 11 compliance. **Since 2024, Montrium has worked with 9 universities and academic research institutions.** ### Organization’s Profile Academic institutions face their own version of the Part 11 challenge. Research is spread across faculties, labs, and departments, each with its own way of working. Central IT may own the platform while research teams own the records. And unlike a pharmaceutical company, most universities do not have a dedicated quality function responsible for keeping regulated systems compliant. The subject of this case study is the following organization: - **Type of organization:** Academic research institution - **Regulatory environment:** FDA-regulated research activities requiring compliance with 21 CFR Part 11 - **Users:** Research teams, study coordinators, principal investigators - **Trigger:** Affiliated research and hospital groups preparing for a regulated study, or partners asking for evidence of Part 11 compliance [![CTA\_Adobe Validation free package\_L](https://no-cache.hubspot.com/cta/default/334618/interactive-222843522369.png)](https://blog.montrium.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKi5t0N7vtcoUENOJsoQ7vznvNqVjFq0k6K8WIT2S4jRwjXVq6AVwHV13Rhqt5C0ZivMYQlt65%2B9pRQIWDsDykk7kthcWAAEYf43gJpTeyt5tqZB1i3G1j7KjMxA7SyVEuEMXtBi5WS2NbpcK3MrtU0w2H2uEV8Q0s4EnDgq%2F4SPsza8l%2BnSWIaTr%2FT%2BQtpOSbns8ArUf3OVLpa7ibutKbyiiMhxpCQdA%3D%3D&webInteractiveContentId=222843522369&portalId=334618)   ## Initial Challenges Selecting the right tool is only the starting point. The regulated organization carries final responsibility for Part 11 compliance, which meant the institution had to define who owns the system, how it is used, and how it stays compliant over time. ### Governance and Accountability Lack of clarity in the oversight structure, ownership, and decision-making framework: - No formal governance structure for regulated electronic records - Multiple departments managing records independently Without a defined owner, no one was accountable for approving changes, granting access, or answering an inspector’s questions about the system. ### Process and Documentation Lack of process definition describing the activities, workflows, and procedures that people follow: - Lack of documented procedures supporting electronic signatures - Limited experience with change management in regulated cloud-based systems Cloud platforms update on the vendor’s schedule, not the institution’s. Without change control, each new release could affect the validated state of the system without anyone noticing. ### Regulatory Readiness Lack of expertise surrounding 21 CFR Part 11: - Uncertainty regarding 21 CFR Part 11 expectations - Questions surrounding validation practices Teams were unsure what “validated” meant in practice, how much testing was enough, and whether every document in a validation package was really required. ## Montrium's Approach Montrium employed a phased methodology focused on technology, processes, people, and governance. Each phase built on the one before it, so the institution was never writing procedures for roles that had not been defined, or training users on processes that did not yet exist. ### Phase 1: Governance and Responsibility Framework Why it mattered: Every later deliverable depends on knowing who is responsible. Starting here gave each department a clear owner and the institution a single line of accountability. **Activities** - **Stakeholder interviews** - Development of a responsibility model defining: System Owner, System Administrator, Business Process Owner, End User Deliverables - Compliance oversight structure ### Phase 2: Development of Procedures Why it mattered: Procedures turn good intentions into repeatable, inspectable practice. Working from templates meant the institution adapted proven SOPs to its context instead of writing them from a blank page. **Activities** - Work with stakeholders to define operational procedures supporting compliance, including the following topics: - Acceptable use and management of electronic signatures - System use - System administration - User access management - Change control and configuration management **Deliverables:** - SOP templates ### Phase 3: Validation Support Why it mattered: Validation does not mean retesting everything the vendor has already tested. Building on vendor documentation let the institution focus its effort on its own configuration and intended use. **Activities** - Develop a streamlined validation strategy that leverages vendor-supplied test documentation **Deliverables:** - Validation document templates ### Phase 4: Training Support Why it mattered: A compliant configuration only works if people use it correctly. Role-based training made sure end users knew what was expected of them at the moment of signature, and administrators knew how to keep the system in a validated state. **Activities** - Role-based compliance awareness and system training workshops (for End Users and System Administrators) **Deliverables:** - Training materials [![CTA\_Adobe Validation free package\_L](https://no-cache.hubspot.com/cta/default/334618/interactive-222843522369.png)](https://blog.montrium.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKi5t0N7vtcoUENOJsoQ7vznvNqVjFq0k6K8WIT2S4jRwjXVq6AVwHV13Rhqt5C0ZivMYQlt65%2B9pRQIWDsDykk7kthcWAAEYf43gJpTeyt5tqZB1i3G1j7KjMxA7SyVEuEMXtBi5WS2NbpcK3MrtU0w2H2uEV8Q0s4EnDgq%2F4SPsza8l%2BnSWIaTr%2FT%2BQtpOSbns8ArUf3OVLpa7ibutKbyiiMhxpCQdA%3D%3D&webInteractiveContentId=222843522369&portalId=334618) ## Key Outcomes and Lessons Learned Montrium’s phased approach led to the following key outcomes: - **Clear Accountability.**Ownership and accountability were formally documented and communicated across departments. - **Consistent practice.** The institution established standardized practices for using and managing electronic signatures. - **Inspection readiness.** The institution maintained documented evidence supporting the system’s intended use and compliance requirements. - **Confident users.** Users understood both how to use the system and their responsibilities under 21 CFR Part 11. Montrium’s phased approach led to the following key lessons learned: - Clearly defining responsibilities early in the project helps avoid gaps in ownership and accountability. - Technology alone does not lead to compliance. Validation is only one component of 21 CFR Part 11 compliance. Long-term success depends on governance, procedures, training, and ongoing oversight. - Starting from proven templates saves time. Teams still need to adapt them to their context, but they are not starting from zero. ## What This Means for Your Institution If your institution is preparing to use electronic signatures in FDA-regulated research, you may face the same questions this team did. Who owns the system? Which procedures do you need? How much validation is enough? How will users be trained? Montrium helps academic institutions answer them, whether you want templates to work through on your own or a team to guide you from start to finish. 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