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Experienced Personal Consulting
Helping you design success into your Quality Management System!
About us
QMS guru
QMS guru provides Quality Management System development, audit readiness, Standard Operating Procedure development, training, and consulting services to the pharmaceutical, medical device, and biotechnology industries.
In addition, we have an existing library of procedures that can be purchased as bundles or individually. Consulting service hours can be added to customize those procedures for your specific needs.
Our services include auditing, we have experience personnel to perform audits of Good Manufacturing Practices, 21CFR820, ISO 13485, MDR, IVDR, GLP, GCP and CAP/CLIA.
Out of the Box QMS
When purchasing our out-of-the-box documents, we provide pre-written policies, standard operating procedures, forms, templates and manuals in the area of GMP (Good Manufacturing Practice), Manufacturing and Product Realization, Quality Management, Quality Control, Validation, and Regulatory processes.
QMS Development Project
When purchasing a QMS customization project, we are focused on bringing the right solution to your company. Our approach identifies your company size and resources and incorporates it into the development of your Quality Management System while maintaining compliance and being nimble. Our experience and expertise will allow you to make sound decisions faster.