Pharmaceutical compliance software that enforces execution and protects quality

Q: How does Process Street help pharmaceutical companies stay compliant?

We turn SOPs, GMP requirements, and documentation workflows into trackable, enforced processes that generate audit-ready proof by default.

Q: Can I manage batch records, deviations, and validation in one system?

Yes. You can standardize and automate all critical workflows, from production to QA to compliance oversight.

Q: Is Process Street secure for regulated pharma data?

Absolutely. We're SOC 2 Type II and ISO 27001 certified. Data is encrypted, access-controlled, and fully auditable.

Q: Does this support FDA, EMA, and global GxP regulations?

Yes. You can build workflows that align with 21 CFR Part 11, EU Annex 11, and other regulatory requirements.

Q: Can I manage training, SOPs, and change controls without IT?

Yes. Process Street is no-code, quality and compliance teams can build and update workflows without developers.

Q: Can it scale across labs, manufacturing sites, and global teams?

Yes. Our platform supports multi-site deployments, localized processes, and global oversight from a single system.

Process Street helps pharmaceutical teams automate GMP workflows, manage documentation, and stay compliant with FDA, EMA, ISO, and GxP requirements, without the complexity of legacy systems.

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Trusted by more than 3000 companies

Compliant collaboration on a single platform

From batch records and CAPA to validation and training, Process Street transforms compliance-critical processes into structured workflows that are executed consistently and logged automatically.

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GMP & GxP workflow automation

Turn procedures into enforceable step-by-step workflows aligned with GMP, GLP, and GCP standards.

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SOP execution & batch record tracking

Assign tasks, log actions, and link records with full traceability for batch manufacturing and quality assurance.

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CAPA & deviation management

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

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Change control & validation workflows

Manage equipment, product, and procedural changes with approval routing, validation steps, and documentation control.

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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 & certification management

Assign GxP-specific training, automate renewals, and track completions across departments and roles.

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Document control & versioning

Create, review, approve, and distribute controlled documents with full audit history and role-based access.

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Audit prep & inspection readiness

Assign tasks, gather evidence, and maintain audit logs for FDA, MHRA, EMA, and internal quality audits.

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Vendor qualification & supplier oversight

Collect documentation, assign approval workflows, and manage risk reviews for third-party suppliers and manufacturers.

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Frequently asked questions

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

How does Process Street help pharmaceutical companies stay compliant?

Can I manage batch records, deviations, and validation in one system?

Is Process Street secure for regulated pharma data?

Does this support FDA, EMA, and global GxP regulations?

Can I manage training, SOPs, and change controls without IT?

Can it scale across labs, manufacturing sites, and global teams?

Unwavering security & compliance focus

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