Your Quality Management System (QMS) is usually the first place a GMP auditor will ask to see upon inspection. The key with a 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 also demonstrate that staff are following those documented procedures (often by ensuring there’s relevant documentation available that proves that they are).
Options for Implementing a QMS:
- Do it yourself
- Do it yourself with expert guidance
- Outsource it completely
1. Do It Yourself (DIY)
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.
2. 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.
3. Outsourced Solution
We strongly recommend that the company staff to learn how to write a Quality Management System, 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 and communication skills to ensure that the information is clearly, sequentially and logically laid out; facilitating both the training and the operator. Our consultants look for business process improvements while ensuring that obvious productivity gains are included in 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. In addition, our writers can often draw on the depth of past projects in the office to get the best solution.
contact us at one of our offices around the world for more information or to request a quote for Quality Management System development or remediation.
If you want to read more about Quality Management Systems or data integrity, click on the relevant links.