Downloadable QMS templates

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

Mike

The sample on the website really helped sell the templates to me. Me and a couple of other fellows run a consultancy here on medical devices, mostly musculoskeletal. I liked the emphasis on 13485 since most of the small companies we deal with will likely hit the world stage before the US stage. Looking forward to working with the tools.

USA
ISO 13485 Template

Simona

I used your QMS pack to first “modernize” our QMS and then this year to update to 2016 standards. I found your QMS pack for 2016 to be very helpful and easy to use.

USA
ISO 13485 Template

Chris

We are very satisfied with the template pack and used them for setting up our quality management system.

The documents are very good, readable and understandable and the structure is clear. Overall our impression is that the documentation pack is of a high quality and it was necessary for us to make fast progression. 100% value for money.

Netherlands
ISO 13485 Template

Computer System Validation Templates / Protocols
Computer System Validation Templates / Protocols
$900.00 US
Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build a your computer system validation protocols.   The templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time. Ideal for startup pharmaceutical or life science companies who must comply with PIC/S (TGA) or FDA GMP guidelines.   We offer a simple series of templates that can be scaled to suit your validation needs.
ISO 13485 Templates – Medical Device Quality Management System
ISO 13485 Templates – Medical Device Quality Management System
$900.00 US
Do it yourself ISO 13485 or QSR 820 compliance   Built in Microsoft® Word for easy editing, these medical device QMS templates are the quick and easy way to build a Quality Management System (QMS) compliant with the ISO 13485 standard or QSR 820 regulations.   The medical device QMS templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time. Ideal for medical device companies who are preparing to commence manufacture of devices controlled by the FDA, TGA or any other regulatory authority.
Pharmaceutical Quality Management System Templates
Pharmaceutical Quality Management System Templates
$900.00 US
Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build a Quality Management System (QMS) for ISO, GMP or other regulatory compliance.   The templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.   deal for startup pharmaceutical or life science companies who must comply with TGA or FDA GMP guidelines.
Pharmacovigilance Template Pack
Pharmacovigilance Template Pack
$1,000.00 US
This Pharmacovigilance Template pack is designed to be a simpler version of full-scale Pharmacovigilance systems for high-risk products. It is a good base for starting up a Pharmacovigilance system before adding further layers of complexity (as per your organisation’s requirements).