Your Quality Management System (QMS) is usually the first place a GMP auditor will ask to inspect upon arrival. The key with a QMS is to “say what you do and then do what you say”. This means that not only does your QMS need to document and specify the processes in your facility but you’ll also needs to provide evidence that that staff are following those documented procedures as they are written (usually by ensuring there’s relevant documentation available that proves that they are, e.g. logbooks, batch records, training records, etc.).
PharmOut offers services in the form of templates as well as in the form of consultants to support the development and maintenance of a Quality Management System compliant with ICH Q10 – this QMS guideline is the most suitable starting point for blood and tissue banks.
Our GMP technical writing team is carefully recruited to not only provide you with an experienced technical writer but a writer who also brings GMP consulting strength to your project. Our writers are professionally trained to industry standards and have great interviewing and communication skills to glean crucial information from processes in order to clearly, sequentially and logically document them which facilitates both the training and the operator. Our consultants also look for continuous business process improvements while ensuring that obvious productivity gains are included in the systems.
PharmOut offers the following services for QMS development and maintenance:
- Gap assessments to determine if an existing Quality Management System meets the current regulatory framework.
- Mock audits to determine the health of a Quality Management System and to see if appropriate records are being kept.
- Technical writing services to create or improve an existing Quality Management System.
- Templates for creating a complete QMS from scratch or a single standard operating practice (SOP).
If you would like a quote or to ask questions, please contact us.