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.
Pharmaceutical Quality Management System Templates
USD $900.00
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.
Description
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
production
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 resources, facility and equipment
information resources
measuring and monitoring devices
continual improvement
validation
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.
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.
Related products
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.
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.