Short answer: A Regulatory Information Management (RIM) platform for medical device and IVD teams can support 21 CFR Part 11-controlled work. No software product makes your organization compliant on its own.
Start with intended use: Which FDA-regulated electronic records and signatures will the system create, modify, maintain, archive, retrieve, or transmit? Once you answer that question, you can evaluate the product’s technical controls, the evidence it provides, and the procedures and validation work that remain your responsibility.
For medical device and IVD teams, a RIM system and an electronic quality management system (eQMS) typically play different roles. A RIM manages submissions, registrations, renewal dates, regulatory intelligence, and jurisdiction-specific records. An eQMS manages quality processes such as CAPA, design controls, training, and controlled procedures. Either system can hold Part 11-relevant records. What determines the applicable requirements is the specific product, configuration, interfaces, records, and procedures, not the software category alone.
What does 21 CFR Part 11 cover?
21 CFR Part 11 establishes criteria under which the FDA considers certain electronic records, electronic signatures, and handwritten signatures executed to electronic records to be equivalent to paper records and handwritten signatures. FDA guidance indicates that Part 11 applies to electronic records required by predicate rules and to certain electronic records submitted to the agency, with the scope interpreted according to the applicable requirements.
That scope matters when evaluating RIM software for Part 11. A document being electronic does not automatically bring every system that stores or processes it into Part 11. Organizations need to identify the applicable predicate rule, the regulated record, how they rely on the electronic version, and which system functions affect record integrity. That assessment should be documented as part of the organization’s compliance process.
Which Part 11 controls should you evaluate?
When evaluating RIM software for medical device and IVD workflows, map the system’s controls to your intended use and applicable predicate rules. Key areas to evaluate include:
- System access: §11.10(d) limits system access to authorized individuals.
- Audit trails: §11.10(e) addresses secure, computer-generated, time-stamped audit trails and requires that changes do not obscure previously recorded information.
- Signature manifestation: §11.50 requires a signed electronic record to show the signer’s printed name, the date and time, and the meaning of the signature.
- Signature-to-record linking: §11.70 requires signatures executed to electronic records to be linked to those records so they cannot be removed or transferred to falsify another record.
- Signature uniqueness: §11.100(a) requires each electronic signature to be unique to one individual and not reused or reassigned.
- Operational and authority checks: Evaluate whether the system enforces permitted sequencing, role authority, and the actions each user is authorized to perform.
- Record availability: Confirm how records and associated metadata are retrieved, copied, retained, and made available for inspection throughout the required retention period.
A useful way to evaluate these controls is to look beyond the feature list. Ask what happens when a record is changed twice, approved, and then superseded. Request the audit trail and review how the system preserves the history of those actions. That demonstration can reveal more about practical record integrity than a list of features.
Why is Part 11 a shared-responsibility question?
Technical controls are necessary, but they are only one part of a Part 11 assessment. Your organization remains responsible for determining intended use, identifying predicate-rule obligations, approving configuration, assigning access, training users, controlling procedures, reviewing audit trails where appropriate, managing electronic signatures, retaining records, and validating the system and its interfaces to the extent required by your risk assessment.
FDA guidance points to a justified, documented risk assessment covering the system’s effect on product quality, safety, and the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. A RIM platform can provide documentation, testing evidence, release information, and qualification support. Your organization must demonstrate that its configured use is fit for purpose.
The same division of responsibility applies to cloud systems. Vendor hosting can take server provisioning and certain infrastructure responsibilities off your plate. It does not eliminate your security review, privacy review, vendor qualification, interface testing, change control, business-continuity planning, or validation of your intended use.
How does RegDesk support Part 11 and security requirements?
RegDesk is a RIM platform purpose-built for medical device and IVD regulatory teams with security and compliance standards in place. The platform includes role-based access control, SSO/SAML 2.0, multi-factor authentication, AES-256 encryption at rest, TLS 1.3 in transit, and isolated single-tenant AWS customer environments. RegDesk maintains a current SOC 2 Type II report and holds ISO/IEC 27001 certification. The platform provides controls designed to support FDA 21 CFR Part 11 and GxP use cases, and its privacy and security program is designed to support GDPR requirements.
RegDesk provides the SOC 2 report, ISO/IEC 27001 certificate, validation package, DPA, and other diligence materials to support customer evaluation. These materials should be assessed against your intended use and configured workflows because that is the assessment your organization needs to be able to demonstrate. Security attestations and platform controls do not, by themselves, make an implementation Part 11 compliant.
That distinction is important: the platform supplies capabilities and evidence; your organization owns the intended use, configuration, procedures, validation, and compliance.
Is SOC 2 Type II the same as Part 11?
No. SOC 2 Type II and 21 CFR Part 11 address different requirements and serve different purposes.
A SOC 2 Type II report is an attestation examination of controls against selected Trust Services Criteria over a defined period. It can be useful for security and vendor-risk review, but it does not establish that a particular RIM implementation complies with Part 11.
Part 11 is an FDA regulation governing specified electronic records and electronic signatures. Whether it applies depends on factors including predicate rules, intended use, configuration, procedural controls, and validation.
| Criterion | SOC 2 Type II report | 21 CFR Part 11 |
|---|---|---|
| What it is | An attestation examination against selected Trust Services Criteria | An FDA regulation on electronic records and signatures |
| Who produces it | A third-party CPA firm, over a defined observation window | The FDA issues the regulation; your organization produces compliance evidence through assessment, configuration, procedures, and validation |
| What it covers | The vendor’s control environment | Your regulated records, your signatures, your intended use |
| What it proves about your system | That controls in scope operated as described | Nothing on its own about a specific implementation |
| When you use it | Security diligence and vendor qualification | Scoping, validation, and inspection readiness |
| Who’s accountable | The vendor, for controls in scope | The organization for its regulated use |
RegDesk also holds ISO/IEC 27001 certification, which is a separate information security management standard. Like SOC 2, it can support security and vendor-risk review, but it does not replace a Part 11 assessment.
Two documents answering different questions. Neither substitutes for the other, and only one of them is yours to own.
Does a RIM replace an eQMS?
Usually not. A RIM and an eQMS typically manage different types of regulated information and workflows.
Define ownership record by record and workflow by workflow rather than expecting one system category to replace another:
- A RIM is often the system of record for market registrations, submission plans, health-authority correspondence, renewal dates, regulatory intelligence, and country-specific submission artifacts.
- An eQMS is often the system of record for CAPA, nonconformance, design controls, training, audits, quality procedures, and controlled quality documents.
- A PLM or product-data system usually owns design structures, part numbers, configurations, and engineering changes. Learn more in our RIM vs PLM document.
When these systems exchange regulated data, the interface needs governance of its own. Document record ownership, field mapping, approval authority, error handling, audit history, signature context, reconciliation, and change control.
A compliance claim about either endpoint validates nothing about the pipe between them, and the pipe is where record integrity usually breaks.
How do EU MDR and EUDAMED fit into this?
EU MDR is separate from FDA 21 CFR Part 11. Medical device companies may manage both sets of work in the same RIM system, but the legal requirements should remain distinct.
Under the EU MDR, manufacturers maintain technical documentation, address the General Safety and Performance Requirements (GSPRs), prepare an EU Declaration of Conformity where applicable, and meet device and economic-operator registration obligations. EUDAMED is the European database for specified electronic systems and data. It is not a repository for an entire GSPR checklist or technical dossier.
As of May 28, 2026, the first four EUDAMED modules are mandatory: Actor Registration, UDI/Devices Registration, Notified Bodies & Certificates, and Market Surveillance. A RIM can organize the related data, requirements, and deadlines, but it does not replace regulatory judgment or the underlying submissions.
What evidence should you ask for?
Ask for these materials before the security review closes, and ask for them in writing:
- A current SOC 2 Type II report and ISO/IEC 27001 certificate, with the exact services and environments in scope.
- A Part 11 and GxP assessment or qualification package, including a requirements-to-controls mapping.
- Documentation for audit trails, signature manifestation, signature linking, identity controls, access review, record export, and retention.
- Validation support, including test evidence, release notes, known limitations, change-notification practices, and the responsibility split between platform and customer.
- Data-flow and interface specifications for every connected eQMS, PLM, ERP, identity, and document system.
- Backup, disaster-recovery, incident-response, subprocessor, and business-continuity evidence.
- A demonstration using your actual record types, roles, approval steps, and exception scenarios.
The goal is to evaluate evidence against the way your organization will actually use the system, rather than relying on a generic claim that a product “supports Part 11.”
Who is RegDesk built for?
RegDesk is a RIM platform purpose-built for medical device and IVD regulatory teams rather than general pharmaceutical submissions. If your organization is centered on drug submissions, confirm that the product scope, data model, and supported workflows fit your requirements before proceeding.
Product capabilities are only one part of a defensible Part 11 assessment. Review the documentation, test representative workflows, complete security and privacy diligence, and document who owns configuration, validation, procedures, and change control.
RegDesk supports that evaluation. Your organization owns the intended use, and with it the compliance.
When might you not need a RIM for your Part 11 requirements?
A narrower system scope may be appropriate in situations such as these:
- None of your regulated records live outside your eQMS. If your Part 11 scope is fully covered by a validated system you already operate, adding a second system may add interfaces and validation requirements without addressing an existing control gap.
- You have not completed your scoping assessment. Until you identify the applicable predicate rules and records in scope, you cannot determine which controls you need to evaluate.
- You are pre-first-submission with a single market. If there are no registration records or other in-scope regulatory records to manage, the immediate need for a RIM may be limited.
- Your immediate gap is procedural rather than technical. If the problem is that nobody reviews audit trails, additional software will not solve the underlying issue. A procedure and an accountable owner will.
The evaluation becomes more important as regulated records span multiple systems, because record ownership and system interfaces become part of the compliance assessment.
Frequently asked questions
Does a platform’s Part 11 claim make my organization compliant?
No. A vendor claim may indicate that the platform includes relevant controls, but your organization must still assess scope, configure the system, establish procedures, train users, control access and signatures, and validate its intended use based on risk.
Is a SOC 2 Type II report evidence of Part 11 compliance?
Not by itself. SOC 2 supports security diligence and vendor-risk review. A Part 11 assessment is a separate evaluation of regulated records, electronic signatures, controls, procedures, configuration, and validation.
Must every electronic record in a RIM follow Part 11?
Not automatically. Determine whether the record is required by an FDA predicate rule or is an electronic record submitted to FDA within Part 11’s scope, and document how the organization reached that determination.
Can a RIM and an eQMS both hold Part 11-relevant records?
Yes. What matters is intended use and record ownership in each system. Where regulated data moves between systems, interfaces, duplicated records, approvals, and related controls require documented governance and appropriate validation.
Does RegDesk support Part 11 for eQMS workflows?
RegDesk is a RIM platform, not an eQMS. It manages regulatory submissions, registrations, renewal deadlines, regulatory intelligence, and jurisdiction-specific regulatory records. If your Part 11 scope is centered on CAPA, design controls, training records, or controlled quality procedures, those workflows typically sit in an eQMS. Where both systems hold regulated records, each requires its own intended-use assessment, validation, and documented record ownership.
Is RegDesk a consultancy?
No. RegDesk is a software platform for medical device and IVD regulatory teams. It provides regulatory information, workflow capabilities, controls, and supporting evidence. Regulatory judgment, procedures, validation, and compliance remain with your organization.
Can compliant software guarantee regulatory approval?
No. Record-integrity controls and effective regulatory workflows can support audit readiness and more controlled operations, but regulatory approval decisions remain with the applicable regulatory authority or notified body.
