FDA 21 CFR Part 11

FDA 21 CFR Part 11 compliance software that turns documentation into proof

Q: What is FDA 21 CFR Part 11 compliance software?

It’s software that helps regulated companies meet the FDA’s requirements for electronic records and electronic signatures.

Q: How does Process Street support Part 11 compliance?

We automate task tracking, enforce sign-offs, control access, and generate audit-ready logs — all within structured workflows.

Q: Does it support electronic signatures?

Yes. Process Street collects and logs digital signatures with user identity, date, and time — ready for FDA inspection.

Q: Is it secure and audit-ready?

Yes. We support SOC 2, ISO 27001, and provide encrypted audit logs, access control, and version history.

Q: Can we validate Process Street for use in a regulated environment?

Yes. We support customer-led validation and provide tools to help document and execute validation protocols.

Q: How quickly can we go live?

Most teams are live in days using compliance-ready templates and guided onboarding.

Enforce electronic record controls, automate sign-offs, and maintain audit readiness with Process Street. The FDA 21 CFR Part 11 compliance software built for regulated teams.

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Trusted by more than 3000 companies

What’s your biggest 21 CFR Part 11 compliance challenge?

Use automated workflows to manage electronic records, route approvals, and collect digital signatures.

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21 CFR Part 11 compliance is more than documentation. It’s execution.
If your systems rely on paper trails or disconnected tools, proving control over your electronic records becomes a risk.

Process Street is FDA 21 CFR Part 11 compliance software that automates documentation, enforces process controls, and generates proof — every step of the way.

Enforce electronic record workflows

Capture data, assign tasks, and collect approvals using structured workflows that meet regulatory expectations.

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Use verified electronic signatures

Collect time-stamped, identity-verified digital sign-offs for every controlled step.

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Track execution with full audit trails

Log every step in the workflow automatically with date, time, and user identity attached.

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Control access and permissions

Assign role-based access to workflows and documents to enforce internal controls.

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Meet Cora,
your AI compliance partner

Cora is your digital compliance monitor. Built into Process Street, Cora helps you enforce Part 11 controls, flag risks, and stay inspection-ready without the manual overhead.

Builds and updates controlled workflows Use AI to help create and validate processes that follow FDA guidelines
Tracks sign-offs in real time Monitor approval status and overdue signatures at a glance
Flags missing steps or violations Catch skipped controls or invalid entries before they become inspection issues
Recommends process improvements Use workflow data to close gaps and improve audit outcomes

With Cora, 21 CFR Part 11 compliance becomes active, not reactive.

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Version control for SOPs and controlled docs

Manage updates and maintain historical records with full version tracking and change logs.

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Version control for SOPs and controlled docs

Centralize controlled documents

Store SOPs, validation protocols, test records, and approval forms inside workflows.

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Support system validation efforts

Tie validation steps and protocols directly into executable workflows for repeatable control.

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Automate regulatory review and approval

Route procedures and compliance tasks to QA, RA, or legal with built-in routing and approvals.

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Regulated teams use Process Street’s FDA 21 CFR Part 11 compliance software to enforce process control and meet FDA expectations:

Electronic record management

Track inputs, changes, and approvals across all controlled forms and processes.

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Electronic signature enforcement

Collect and log sign-offs from authorized users with full timestamp and ID tracking.

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SOP execution and sign-off

Run procedures step by step and capture evidence of compliance for each run.

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Validation protocol execution

Manage test scripts, deviations, and approvals with automated workflows.

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Audit preparation and documentation

Generate complete audit trails for any SOP, signature, or workflow in seconds.

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Cross-functional compliance workflows

Coordinate work across QA, RA, IT, and legal with structured approval flows.

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Frequently asked questions

Can't find the answer you need? Contact our support team.

What is FDA 21 CFR Part 11 compliance software?

How does Process Street support Part 11 compliance?

Does it support electronic signatures?

Is it secure and audit-ready?

Can we validate Process Street for use in a regulated environment?

How quickly can we go live?

Trusted by 3000+ companies

From biotech to pharma and medical device companies, Process Street powers FDA 21 CFR Part 11 compliance software trusted in regulated industries.

Data protection & security

ISO27001 compliance

Process Street is ISO 27001 certified, confirming compliance with global standards and a strong commitment to protecting customer data through audited, continuously monitored security controls.

Data protection & security

SOC 2 Type II compliance

Process Street has passed a SOC 2 Type II audit, confirming that it meets various criteria for safeguarding customer data. An independent external auditor has verified the effectiveness of the controls implemented by Process Street.

Healthcare information privacy

HIPAA compliance

HIPAA, a federal law, safeguards patient health information. Process Street's robust security measures include the option for a Business Associate Agreement upon request, ensuring HIPAA compliance.

Data protection & security

AWS CIS compliance

The CIS AWS Foundations Benchmark provides security best practices for AWS environments. Process Street's compliance ensures a secure cloud infrastructure by following established guidelines for configuration and monitoring.

EU Data protection & privacy

GDPR compliance

The General Data Protection Regulation (GDPR) is an EU law designed to protect the privacy of individuals and businesses in the EU economic area. It establishes rules for how personal data is collected and handled. Read our GDPR statement

Data protection & privacy

CCPA compliance

The California Consumer Privacy Act (CCPA) gives California residents more control over their personal data, including rights to access, delete, and opt out of data sales. Process Street ensures compliance through transparent practices.

Security & privacy

Artificial intelligence

Your data is never used to train AI models. Any data read or created by a workflow is exclusive to that particular workflow instance and cannot be accessed otherwise, even from within the same organization.

Data sovereignty & infrastructure

Data residency & private cloud

Choose where your data is stored with support for US, UK, Canada, EU, and UAE regions. Customers can also opt for private cloud deployment in their own VPC for maximum control and security.

Backed by happy clients

With Process Street we've been able to bring documentation to life… allowing us to adapt processes quickly, improve governance and achieve consistent results