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Virtually in Charge: Quality Management System (QMS) for a Virtual Company Christopher Rush, President, FDAQRC
Risk Evaluation
Major Risk: Inspection by a Health Authority reveals no QMS when one is required resulting in regulatory action
Major Risk: Audit by client reveals no QMS resulting in loss of business
Major Risk: Quality issues detected through compliant investigation demonstrates noncompliance to the regulations
Minimum Elements of QMS
The following are a list of minimum elements to a QMS for a virtual company:
1. Documentation Controls which includes the appropriate guidance on which documents and records need to be maintained and the retention period for those documents.
2. Change Controls to establish a uniform process for controlling the creation and issuance of new documentation (including SOPs), and changes to existing documentation and labeling. This process also incorporates the approval and distribution methods in order to comply with the Quality Manual, the Quality System Regulation, and/or any applicable International Standards.
3. Personnel training is to ensure that all employees obtain the necessary training in order to correctly perform the duties of their job position. These procedures shall be prepared in accordance with the regulatory requirements, International Standards, and Quality Manual.
4. Material and Vendor management to define the process for the selection, approval, and continued evaluation of suppliers of products.
5. Non-conformances and Out Of Specifications to define the oversight requirements and processes to be followed for the control of product or materials that do not meet specified requirements.
6. Deviation and Corrective and Preventative Action (CAPA) to describe the process for oversight, identification and handling of product and material deviations that may occur.
7. Clinical Trial Material (CTM) / Investigational Product(IP) lot release to describe the expectations for and circumstances under which IP may be released for shipment to approved clinical research sites.
The Road Map
What process are we performing?
How could this be viewed by a Regulator?
What oversight are we performing?
Do we need a Quality Management System?
What risks are involved if we do not implement a QMS?
