Products
PharmOut offers the following software products designed specifically for regulated industries.
Quality Management Systems
PharmOut offers an integrated suite of Microsoft® Word templates suitable for creating a Quality Management System for ISO, GMP or other regulatory compliance. Simple to use, they will save you hours of development time.
We do not believe that external consultants can write your Quality Management System for you. It has to be written by internal staff, however we can assist you and greatly reduce your development time.
They include nuances and information you will think of only if you are very familiar with implementing such systems.
ISO 9001:2000 Quality Management Systems
PharmOut offers a simplified ISO 9001:2000 Quality Management System for Medical Device Manufacturers who do not manufacture Medical Devices in Australia and need a simple system.
ISO 13485:2003 Quality Management Systems
PharmOut also offers a simplified ISO 13485:2003 Quality Management System for Medical Device Manufacturers who manufacture Medical Devices in Australia and need the slightly more advanced system.
FDA's QSR 820 Quality Management Systems
Finally PharmOut offers a FDA QSR 820 Quality Management System for Medical Device Manufacturers who manufacture Medical Devices for the USA and FDA regulated markets.
These generic systems which have not been modified to suit your requirements are usually less than AUD 3000. Regretfully they are only available for sale in Australia.
MasterControl Website
PharmOut is the Australian distributor for the MASTERControl suite of integrated Quality and Compliance management software tools for FDA and ISO regulated companies.
The suite includes:
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