Built in Microsoft® Word for easy editing, these templates are the quick and easy way to build 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.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
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.
Built in Microsoft® Word for easy editing, the Validation Template pack includes the templates for developing Validation Plans, Specifications, Protocols and Reports in accordance with FDA and PIC/S requirements for qualification and validation.
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.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
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.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
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. Ideal for startup pharmaceutical or life science companies who must comply with TGA or FDA GMP guidelines.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
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).
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
