Quality Management Systems

PharmOut's experienced quality assurance and technical document writers can quickly write a quality management systems for virtually any industry sector and have written documents for the following industries - pharmaceutical, medical device, laboratories, research, pesticide testing and (oncology) compounding pharmacies to ensure TGA GMP compliance.

Do it yourself Templates

For smaller companies PharmOut offers a starter set of Quality Management System templates for both Pharmaceutical and Medical Device manufacturers; these documents include policies, procedures and forms commonly used within a manufacturing company.

These can be purchased and downloaded from this website by following the link to the right. In addition, there are sets of validation templates, mainly aimed at equipment qualification and computer system validation (GAMP 5) to be used in a pharmaceutical manufacturing application.

Occasional Expert Guidance

Using the templates above, or modifying exiting documents, our GMP Consultants and / or Technical Document Writers will redraft or only perform a final review.

It is critical to lay a solid foundation, before commencing a Quality Management System The development of templates, style guide, ensuring the appropriate review dates and control of the electronic versions of the documents should be determined before the QMS project is started. .

Often, PharmOut's consultants and / or Technical Document Writers provide assistance to multinational companies in enhancing systems and providing essential relief to busy line staff.

Turn-key solution

We strongly recommend that the company staff write their own Quality System Documentation, however often busy Quality Assurance professionals simply do not have the time to dedicate to "SOP writing". Our experience is that the project timelines slip as the line staff deal with other important and urgent priorities. Dedicated resources without this distraction, ensure that project remains on target and within budget.

Our writers are professionally trained with great interviewing skills to ensure that the information is clearly, sequentially and logically laid out; and facilitating both training and operator. Their training includes looking for business process improvements ensuring that obvious productivity gains are included to the systems.

As our writers engage and work with site staff, we can discuss options and ensure that the alternatives are evaluated and the best operating practice is adopted; our writers can often draw on the depth of past projects in the office to get the best solution.