Industry Support

Pharma & Medical Devices Logistics

Pharma and medical device logistics have extensive regulatory requirements related to data accuracy, batch and serial number tracking and a myriad testing and QC inspection demands. Organisations involved in the distribution and warehousing of medical devices as well as TGA controlled pharmaceutical goods and products, can roll out their own controls and process workflows in ISOPro eliminating manual re-entry of information between the QA/QC activities and ERP/WMS activities.

ISOPro can support client-specific controls for these typical processes:

  • Batch and Expiry Date recording during inbound goods receiving
  • Manufacturer recalls
  • Packaging and tampering checks
  • Temperature recording or storage facilities and holding of external temperature history logs
  • Change management tracking
  • Non-conformance management
  • Document ‘Read & Sign’ recording evidence of the correct distribution of new manuals, procedures, work instructions/SOPs etc. and acknowledgement of understanding by the intended recipients

While ISOPro software does not fall under the requirements of software for medical devices (see TGA guidelines), ISOPro can provide 3rd party software validation (under ISO 80002-2) of the client's processes running in ISOPro.