SOP Software for Regulated Teams

Q: What makes SOP software for regulated teams different from general SOP tools?

Regulated SOP software enforces procedures instead of just documenting them. It includes approval workflows with segregation of duties, version control with full audit trails, role-based access controls, and automatic evidence collection. General SOP tools store documents. Regulated SOP software proves they were followed.

Q: Which regulatory frameworks does Process Street support?

Process Street supports any regulatory framework that requires documented, enforced procedures. Teams actively use it for FDA 21 CFR Part 11, HIPAA, SOX, ISO 9001, ISO 14001, GMP, OSHA, and internal compliance standards. The platform is flexible enough to map workflows to any control framework your organization follows.

Q: How does Process Street help during regulatory audits?

Every workflow execution creates a timestamped, tamper-evident record of who did what, when, and whether it was approved. Export complete audit trails for any procedure or time period. Farmers Insurance runs 43,000+ checklists through Process Street with full auditability across 447 seats.

Q: Can Process Street enforce approval workflows for regulated SOPs?

Yes. SOPs in Process Street move through configurable approval cycles before going live. You define who reviews, who approves, and in what order. The system enforces the sequence. Nothing publishes or executes until every required approval clears.

Q: Is Process Street secure enough for regulated industries?

Process Street is SOC 2 Type II certified, HIPAA compliant, and supports SSO/SCIM, role-based access controls, and enterprise-grade encryption. Data residency options and single-tenant deployment are available for organizations with strict data sovereignty requirements.

Q: How does Cora help regulated teams stay compliant?

Cora is an AI compliance agent that monitors workflow execution in real time. It flags missed steps, identifies procedural drift, and suggests SOP updates when internal or external regulations change. Cora acts on compliance data, not just chat about it.

Turn regulatory procedures into enforced, auditable workflows. Process Street gives regulated teams the approval gates, version control, and audit trails that compliance frameworks demand.

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Pharmaceutical operations director walking along a pathway of documented SOP steps with regulatory framework markers for ISO 9001, FDA 21 CFR Part 11, and EU GMP

Trusted by more than 3000 companies

WHY REGULATED TEAMS CHOOSE PROCESS STREET

SOPs That Prove Compliance, Not Just Document It

Regulated teams in financial services, healthcare, life sciences, and manufacturing face a specific problem: SOPs that exist as documents but cannot prove they were followed. Process Street closes that gap. Every procedure runs as an enforced workflow with built-in approval gates, version-controlled documentation, and automatic audit trails. When auditors ask for proof, you have it. Farmers Insurance uses Process Street to run 43,000+ compliance checklists across 447 seats. Hartford Healthcare enforces SOC 2 and HIPAA workflows through standardized task assignments. NC State University caught $200,000 in missed fees because a team member spotted billing discrepancies during a regulated workflow run.

Regulated SOP workflow showing approval gates and audit trail enforcement

Three Products, One Compliance Operating System

Ops

Turn approved SOPs into automated workflows that enforce every step. Tasks trigger automatically, approvals route to the right reviewers, and nothing moves forward until compliance gates clear.

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Docs

Author, version, and approve SOPs inside a governed document system. Every regulatory procedure is tracked, reviewed, and released through configurable approval cycles that satisfy FDA, HIPAA, SOX, and ISO requirements.

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Cora

AI compliance agent that monitors regulated workflows in real time. Cora flags missed steps, surfaces procedural drift, and suggests SOP updates when regulations change. Not a chatbot. An enforcement layer.

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Built for Teams Where Compliance Carries Consequences

Audit-Ready Trails by Default

Every task completion, approval, and document change is logged automatically. When auditors need evidence, export the full execution history for any procedure, any time period.

Version Control with Approval Gates

SOPs move through review, approval, and release cycles before going live. No unauthorized edits. No undocumented changes. Every version is traceable to the person who approved it.

Regulatory Framework Enforcement

Map procedures to FDA 21 CFR Part 11, HIPAA, SOX, ISO 9001, GMP, or any internal standard. Workflows enforce the specific controls each framework requires at the point of execution.

Role-Based Access and Segregation

Control who can view, edit, approve, and execute each SOP. Role-based permissions and SSO/SCIM integration ensure only authorized personnel touch regulated procedures.

Escalation and Deadline Enforcement

Stalled tasks escalate automatically. Overdue approvals trigger notifications to supervisors. Regulatory deadlines are enforced by the system, not by someone remembering to check.

Compliance Monitoring and Reporting

Track procedure adherence rates, approval cycle times, and exception frequency across teams. Identify compliance gaps before they become findings during your next audit.

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