GRC Software for Pharma and Medical Devices Logistics

Precise compliance management for every batch, every shipment, every record

Manage batch tracking, temperature logs and QA/QC controls in one fully configurable platform without manual re-entry between systems.

Trusted by the world's most compliance-intensive organisations

Managing compliance in pharma and medical device logistics demands precision

Pharma and medical devices logistics organisations have extensive regulatory requirements related to data accuracy, batch and serial number tracking, plus a myriad of testing and QC inspection demands. Without a single source of truth, gaps in visibility across these activities are inevitable.

ISOPro supports a range of industry-specific pharma and medical device standards

• TGA Guidelines
• ISO 13485
• ISO 22000
• ISO 80002-2

How ISOPro gives pharma and medical device logistics organisations complete compliance visibility

Batch and expiry date tracking with full traceability
Temperature and cold chain monitoring history
Read & Sign document control for SOPs and work instructions
Third-party software validation under ISO 80002-2

Every control point, from inbound receiving to recall

From the moment goods are received, ISOPro gives your QA/QC and warehouse teams one system to capture and manage every control point, giving you complete visibility across your quality framework.

  • Record batch and expiry dates during inbound goods receiving.
  • Manage manufacturer recalls.
  • Complete packaging and tampering checks.
  • Record temperature and hold external temperature history logs for storage facilities.
  • Track change management activities.
  • Manage non-conformances.
  • Record Read & Sign evidence for new manuals, procedures, work instructions and SOPs, including recipient acknowledgement.

One system for QA/QC and ERP/WMS an nothing else

If your QA/QC activities live in one system, your ERP/WMS activities in another, and you’re patching everything manuallly, every re-entry point is a chance for errors. ISOPro lets you build your own specific controls and process workflows eliminating the manual handoff between systems entirely.

  • Run QA/QC controls and workflows natively alongside your ERP/WMS data.
  • Eliminate manual re-entry between quality and warehouse systems.
  • Configure controls specific to your own processes, not a generic template.
Person sitting at the centre of a cluttered office desk, viewed from above, surrounded by documents, folders, books and office supplies.

How much time is manual admin in compliance costing you?

Find out in 5 minutes how much time and money you’re spending on manual compliance admin and what you’d gain back with ISOPro.

Documented validation, without the medical device software burden

While ISOPro isn’t regulated as medical device software under TGA guidelines, it can provide independent, third-party validation of the processes your team runs in ISOPro.

  • Client-specific process configuration, validated to your requirements.
  • Third-party software validation under ISO 80002-2.
  • Documented evidence to support your own TGA compliance obligations.

Why pharma and medical device logistics organisations love ISOPro

The system is easy to use and is great for generating monthly reports. The support network is next to none, and all enquiries answered promptly.

Craig P., District Security Compliance Coordinator, Hospital & Health Care

Trusted by organisations with the world's most complex compliance workflows

Join 10,000 users who have replaced fragmented compliance tools and manual admin with one integrated platform. Book a demo and we’ll show you how ISOPro can be fully configured around the specific compliance workflows of your Pharma and Medical Devices Logistics organisation.