Quality Management System remediation or development

Your Quality Management System (QMS) is the first place a GMP auditor will ask to see when they visit. The key is to "say what you do and then do what you say" - meaning that your QMS must document the processes used in your facility and then you have to make sure that your staff are following those documented procedures (and there's a documentation to prove 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:

Purchase our downloadable QMS templates that include all the core procedures needed for GMP compliance and then write the QMS yourself.

Contract PharmOut to supply the resources to implement the QMS for you. We'll research and write it all for you, train your staff and hand it over to your internal resources to maintain.

If your Quality Management System is inadequate

If you are preparing for a GMP audit or an auditor has indicated that your QMS is inadequate, we can offer the following:

A gap assessment to determine where you should focus your resources to ensure compliance

Help with preparing a response to the audit findings and a remediation plan that will deliver a successful subsequent audit

Resources to improve your existing QMS to meet compliance requirements.

To learn more

Contact us for more information or to request a quote.