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.
Pharmaceutical Quality Management System Templates
What’s included in the QMS template pack?
Pack includes the core pharmaceutical quality management system templates for developing policies, standard operating procedures (SOPs) and work instructions for the following areas of your business:
> product information, quotations and orders
> product development
> production and quality planning
> purchasing and receiving
> labelling, packaging, shipping and distribution
> monitoring and measurement of products
> monitoring and measurement of the Quality Management System
> monitoring customer feedback and satisfaction
> management policies, planning and commitments
> management review
> human resourcesplant, facility and equipment
> information resources
> measuring and monitoring devices
> continual improvement
> risk management
> corrective and preventative actions (CAPA)
These areas are specified as being essential components of a pharmaceutical quality management system by the various regulatory bodies e.g. TGA, FDA.
Take a preview – here’s an extract from the template pack
Get a head start with 40 pre-written standard operating procedures
The ideal resource for a quick and easy do-it-yourself QMS implementation, the template pack includes 40 procedure templates (refer to the list on page 3 of the extract above), 19 form templates, 1 manual, 12 master templates & 1 register.
Get help from our regulatory compliance experts
Included in the price is two hours of support via telephone or email. Feel confident in the knowledge that if you have questions or get stuck then you can speak to a GMP compliance specialist to set you on the right path.
Our consultants have many years of experience working in the pharma and medical device industries. You can benefit from their knowledge of what works and what doesn’t when creating and maintaining a pharmaceutical quality management system.