Quality Management System development
Your Quality Management System (QMS) is the first place a GMP auditor will ask to see upon inspection. The key with QMS is to “say what you do and then do what you say”. This means that your QMS must document the processes used in your facility and additionally demonstrate that staff are following those documented procedures (by ensuring that there’s relevant documentation proving that they are).
If you do not have a Quality Management System in place
If you need to implement a QMS there are several options:
- Do it yourself
- Do it yourself with expert guidance
- Outsource it completely
Do it yourself
For smaller companies PharmOut offers a 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. 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.
DIY with expert guidance
Using the purchased PharmOut templates (as described above) or modifying exiting documents, our GMP Consultants and / or Technical Document Writers will redraft or perform a final review of the documents your staff have prepared.
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.
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.
To learn more
Contact us for more information or to request a quote for Quality Management System development or remediation.