Manufacturing

Manufacturing compliance software that automates QMS, enforces ISO and proves every step

Q: How does Process Street help with manufacturing compliance

We turn your procedures into structured workflows that track every step so you meet standards and prove execution without extra manual work.

Q: Can I manage SOPs, CAPA, and training in one system

Yes. Teams use Process Street to centralize and automate SOPs, quality processes, and compliance activities.

Q: Is Process Street secure for regulated manufacturing data

Yes. We are SOC 2 Type II and ISO 27001 certified. All workflows and records are encrypted, access-controlled, and audit-ready.

Q: Does this support ISO 9001 and QMS frameworks

Yes. You can align workflows to your QMS and automate documentation, review, and compliance steps.

Q: Can I assign workflows by site, line, or role

Yes. Workflows are flexible and permission-based so you can deploy by facility, product line, or team.

Q: Do I need IT to maintain workflows

No. Process Street is fully no-code. Ops, quality, or compliance teams can build, launch, and update workflows without technical support.

Process Street helps manufacturing teams build and run compliant, audit-ready processes, from SOPs and inspections to ISO 9001 execution and CAPA tracking.

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Trusted by more than 3000 companies

Compliant teamwork, one platform

From SOP execution and CAPA to audits and training, Process Street turns quality systems into structured, repeatable workflows that are enforced by default and logged automatically.

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SOP execution and production checklists

Standardize procedures with trackable workflows. Assign tasks, capture data, and log completions in real time.

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Quality control and nonconformance tracking

Automate in-line and final inspections. Flag issues, assign corrective actions, and close the loop with traceability.

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CAPA and deviation management

Log deviations, route investigations, and enforce corrective and preventive actions with audit-ready records.

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ISO and QMS compliance workflows

Build structured workflows aligned to ISO 9001, 13485, or your internal QMS with built-in documentation and approvals.

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Meet Cora,
your AI compliance agent

AI-powered compliance, policy, and workflow automation, always up-to-date, always audit-ready.

Creates policies Instantly generate ISO, SOC 2, and HIPAA-compliant policies.
Builds workflows Transform static documents into actionable, trackable workflows.
Monitors regulations Stay ahead of regulatory changes with real-time updates.
Audits automatically Cora flags compliance gaps and keeps your documents aligned.

Compliance isn’t static anymore.

With Cora, your policies, procedures, and workflows stay living, dynamic, and audit-ready automatically.

Discover how Cora works

Training and skills certification

Assign and track role-specific training. Automate recertifications and enforce completion before SOP access.

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Change control and document approvals

Route changes for impact analysis, validation, and sign-off. Maintain version control and audit history.

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Equipment maintenance and calibration workflows

Schedule preventive maintenance, assign service tasks, and document every step to stay compliant and operational.

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Equipment maintenance and calibration workflows

Internal audits and regulatory inspections

Prepare for ISO, FDA, or customer audits with structured audit workflows and built-in evidence tracking.

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Frequently asked questions

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

How does Process Street help with manufacturing compliance

Can I manage SOPs, CAPA, and training in one system

Is Process Street secure for regulated manufacturing data

Does this support ISO 9001 and QMS frameworks

Can I assign workflows by site, line, or role

Do I need IT to maintain workflows

Unwavering security & compliance

Your data's security and privacy are our top priorities. We adhere to the strictest data protection and compliance standards, allowing you to concentrate on delivering unmatched client value.

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