Life sciences compliance software for GxP, FDA, and ISO readiness

Q: How does Process Street help life sciences companies stay compliant?

We enforce GxP-aligned workflows and automate documentation, so every step is tracked, verified, and audit-ready.

Q: Can I manage SOPs, CAPAs, and audits in one platform?

Yes. You can centralize and automate all core quality, regulatory, and clinical operations workflows.

Q: Is Process Street secure enough for regulated environments?

Absolutely. We're SOC 2 Type II and ISO 27001 certified. All data is encrypted, access-controlled, and never used to train AI.

Q: Does this support ISO 13485, FDA, and EMA frameworks?

Yes. You can configure workflows aligned with global regulatory standards and generate documentation to match.

Q: Can I manage training, acknowledgments, and re-certifications?

Yes. Assign training based on SOP versions, track completion, and automate retraining cycles.

Q: Do I need engineering to manage workflows?

No. Process Street is fully no-code, quality and regulatory teams can build, launch, and adapt workflows independently.

Process Street helps life sciences teams automate validation, track documentation, and stay inspection-ready for FDA, EMA, ISO 13485, and global GxP frameworks.

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Trusted by more than 3000 companies

Compliant collaboration on a single platform

From lab operations and manufacturing to regulatory prep and CAPA management, Process Street gives quality, clinical, and regulatory teams one system to enforce standards, prove execution, and adapt fast, without adding complexity.

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GxP-aligned workflow automation

Enforce SOPs across GLP, GCP, GMP, and GDP requirements, assigned, tracked, and logged by default.

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SOP execution & training workflows

Assign SOP tasks, enforce version control, track acknowledgment, and ensure only trained users perform regulated tasks.

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CAPA, deviation & nonconformance management

Capture deviations, trigger corrective action workflows, and track full resolution, automated and audit-ready.

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CAPA, deviation & nonconformance management

Change control & validation workflows

Manage change requests, impact assessments, and validation steps with structured approval routing.

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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

Document control & regulatory evidence tracking

Route documents for approval, version key records, and automatically log every action for inspection prep.

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Document control & regulatory evidence tracking

Audit readiness & inspection prep

Run internal audit workflows, assign evidence collection tasks, and track completion across all functions.

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Clinical site setup & trial management

Standardize site onboarding, document collection, and protocol compliance workflows across research phases.

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Supplier qualification & vendor management

Automate supplier risk reviews, collect required documentation, and track performance across your supply chain.

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Frequently asked questions

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

How does Process Street help life sciences companies stay compliant?

Can I manage SOPs, CAPAs, and audits in one platform?

Is Process Street secure enough for regulated environments?

Does this support ISO 13485, FDA, and EMA frameworks?

Can I manage training, acknowledgments, and re-certifications?

Do I need engineering to manage workflows?

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