TGA compliance that tracks every control and proves every process

Q: What is TGA compliance software?

It's a platform that helps organizations align with Therapeutic Goods Administration requirements by automating documentation, task execution, and audit tracking.

Q: How does Process Street support TGA compliance?

We provide structured workflows, role-based task routing, and audit-ready logs, all tracked and enforced by Cora.

Q: Does this support GMP and ARTG requirements?

Yes. Templates and workflows are customizable for GMP, ARTG registration, post-market obligations, and more.

Q: Can this integrate with our existing QMS or ERP systems?

Absolutely. Use our API or integrations to sync data, trigger tasks, and centralize reporting.

Q: How quickly can we get started?

Most teams launch in under a week using no-code templates, guided onboarding, and best-practice workflows.

Automate therapeutic goods workflows, enforce ARTG policies, and maintain audit-ready logs with Cora, your AI compliance partner.

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TGA compliance that tracks every control and proves every process

Trusted by more than 3000 companies

What's your biggest TGA compliance challenge?

Use structured workflows to align development, labeling, and post-market surveillance with TGA requirements.

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TGA compliance is more than meeting a checklist, it's about proving control.
From ARTG registration to GMP compliance, manufacturers must show every step was followed and documented.

Process Street's TGA compliance platform gives you a structured system to manage every regulatory task. With Cora tracking execution, enforcing SOPs, and preparing logs, you're always ready for inspection.

Automate compliance workflows

Build workflows for ARTG registration, GMP audits, labeling, and product release.

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Assign tasks across regulatory, QA, and manufacturing

Route responsibilities and approvals based on product type or stage in the lifecycle.

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Capture and store supporting evidence

Attach registration files, supplier docs, batch records, and test results to each workflow run.

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Maintain full audit trails

Time-stamped logs show who did what, when, and how, ready for TGA or internal review.

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Meet Cora,
your TGA oversight engine

Cora is your always-on regulatory assistant. Integrated into Process Street, Cora enforces processes, flags gaps, and prepares reports for compliance audits.

Launches compliance tasks automatically By schedule or trigger
Flags missing documents, overdue reviews, or gaps In execution
Enforces approval chains and regulatory SOPs Ensuring compliance at every step
Prepares logs for TGA inspections And certifications

Cora brings structure, speed, and proof
to your regulatory operations.

Discover how Cora works

Customize by product class or risk level

Tailor workflows for prescription medicines, medical devices, or listed goods.

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Customize by product class or risk level

Control access and approvals

Limit visibility and editing based on team, role, or product category.

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Schedule recurring reviews and updates

Automate labeling updates, ARTG renewals, and GMP checks with due dates and alerts.

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Integrate with QMS or regulatory tools

Sync your data across systems like TrackWise, Veeva, or internal quality platforms.

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Regulatory, quality, and operations teams use Process Street's TGA compliance platform to:

Track ARTG registration workflows

Manage timelines, documentation, and submission steps for listed or registered goods.

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Run GMP compliance checklists

Assign daily, weekly, and batch-based tasks with signoffs and log history.

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Monitor product quality and CAPAs

Route complaints, deviations, and recalls through structured resolution workflows.

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Prepare for regulatory audits

Maintain time-stamped records of every SOP, product release, and compliance review.

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Manage supplier and manufacturing approvals

Track qualification, documentation, and risk for third-party manufacturers.

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Enforce ongoing compliance obligations

Ensure continuous alignment with TGA updates and legislation.

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Frequently asked questions

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

What is TGA compliance software?

How does Process Street support TGA compliance?

Does this support GMP and ARTG requirements?

Can this integrate with our existing QMS or ERP systems?

How quickly can we get started?

Trusted by 3000+ companies

From manufacturers to regulatory consultants, Process Street powers
TGA compliance that is clear, controlled, and continuous.

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