Biotechnology compliance software that enforces execution and accelerates breakthroughs

Q: How does Process Street support biotech compliance?

We turn regulatory and quality requirements into trackable workflows, ensuring consistency, audit-readiness, and execution at scale.

Q: Can I use Process Street for GxP workflows and inspections?

Yes. We support GLP, GCP, GMP-aligned workflows with built-in task enforcement, audit trails, and documentation control.

Q: Is Process Street secure for clinical and experimental data?

Yes. We're SOC 2 Type II and ISO 27001 certified. Your data is encrypted, access-controlled, and protected end-to-end.

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

Absolutely. All workflows can be customized to manage documentation, training, compliance, and audit prep in one place.

Q: Does Process Street support multi-site R&D and manufacturing operations?

Yes. The platform scales across teams, labs, and sites with role-based access, flexible workflows, and reporting dashboards.

Q: Do I need IT to update or maintain workflows?

No. Process Street is fully no-code, so quality, compliance, and operations teams can own and update processes without developers.

Process Street helps biotech teams automate SOPs, track validations, and stay audit-ready across R&D, clinical, and manufacturing operations.

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Trusted by more than 3000 companies

Compliant collaboration
on a single platform

From GLP and GCP to FDA and ISO 13485, Process Street gives biotechnology teams a single system to run compliant, consistent, and scalable processes, backed by audit-ready proof.

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SOP execution & version control

Turn procedures into actionable workflows. Assign tasks, enforce sign-offs, and track every revision.

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CAPA & deviation management

Capture deviations, automate root cause analysis, and enforce corrective actions with built-in traceability.

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Regulatory & inspection readiness

Prepare for FDA, EMA, ISO, and internal audits with workflows that build your audit trail in real time.

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GxP workflows (GLP, GCP, GMP)

Standardize and enforce Good Practice guidelines across labs, clinical trials, and production.

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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 tracking

Assign, complete, and log required training with workflows that support GxP compliance and inspection prep.

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R&D documentation & process logging

Standardize experiment logging, data capture, and review workflows to streamline discovery-to-validation.

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Supplier onboarding & qualification

Track qualification steps, documentation collection, and approvals with customizable vendor workflows.

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Change control & validation workflows

Manage process and product changes with structured reviews, impact assessments, and validations.

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Frequently asked questions

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

How does Process Street support biotech compliance?

Can I use Process Street for GxP workflows and inspections?

Is Process Street secure for clinical and experimental data?

Can I manage training, SOPs, and audits in one system?

Does Process Street support multi-site R&D and manufacturing operations?

Do I need IT to update or maintain 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