Quality Management System (QMS) Template Packs

PharmOut offers the following downloadable products designed for organisations needing to comply with PIC/S or FDA regulations or ISO 13485 standards.

Do It Yourself Quality Management System Template Packs

PharmOut offers an integrated suite of Microsoft® Word templates for the quick and cost effective creation of a Quality Management System (QMS) that complies to international regulations and will ensure compliance. Simple to use, they will save you hours of development time.

Pharmaceutical Quality Management System Template Pack

Our in-the-trenches experience has proven that the ISO 9001 framework is an excellent, practical model on which to build a QMS. This, together with the ICH Q10, provides a harmonised model for a pharmaceutical QMS that supports an entire product lifecycle. We've added content to the templates to suit various regional GMP requirements.

The content of the templates supports the requirements of the:

• PIC/S Code of Good Manufacturing Practice, and/or
• ICH Pharmaceutical Quality System Q10, and/or
• ISO 9001:2008 Quality Management Systems (for Pharmaceuticals)

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Medical Device Quality Management System Template Pack

This template pack is for developing a Quality Management System compliant with  ISO 13485:2003 or FDA QSR 820. It's ideal for Medical Device Manufacturers who plan to sell into countries covered by the global harmonisation taskforce (including the US FDA) and are preparing to manufacture.

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