Quality is Everyone's Responsibility... Setting up your QMS is ours!

JMG3 Tissue and Biologics Consulting, LLC is a company specializing in providing quality needs to human tissue banks and eye banks, as well as biologics establishments.  Quality, compliance, regulatory licensure/registration/certification, and auditing are our forte, but we can help with any aspect of setting up your QMS or your tissue and eye bank establishment.

PROGRAM SETUP

JMG3 CAN help with the initial setup of the entire Quality Management System or with only the areas that are needed by your establishment.

GAP ASSESSMENTS

JMG3 CAN perform Gap Assessments of your QMS to see if you have areas of non-compliance with applicable Regulations and Standards. 

ONGOING SUPPORT

JMG3 CAN be available to your establishment to serve as your Quality Lead to oversee your Quality Mangement System as a consultant on limited hour weekly/monthly plans to ensure your organization has Quality coverage.  This can be for a short amount of time until you find a full time Quality Lead or for a longer amount of time if it better suits your needs.

JMG3 CAN assemble all of the necessary documentation, complete all of the required paperwork, create the submission packet, and submit them to all of the federal and state agencies required for your establishment.  

The current list of agencies that JMG3 will complete the licensure, registration, and/or accreditation work and submission for are the following:

• FDA Tissue Bank Establishment
• Tissue Bank Association
• Eye Bank Association
• State of California
• State of Delaware
• State of Florida
• State of Illinois
• State of Maryland
• State of New York
• State of Oregon
• Health Canada

Other international agencies may be possible, but will need to be determined on a case-by-case basis.

We will create the Regulatory Licensure and Registration Schedule and if JMG3 is providing Ongoing Quality Support for you, then we will perform all required registration/licensure related renewal tasks and submit the documentation, packets, etc. prior to their due date to ensure licensures, registrations, and accreditations do not lapse.

INTERNAL AUDITING

JMG3 CAN implement internal auditing SOPs, forms, etc. to properly conduct an internal audit.  JMG3 will ensure you have your Internal Audit Schedule completed in cooperation with management to show when it will occur during the year.  

JMG3 CAN perform the internal audit for your establishment to ensure your quality system is fully functional and compliant with all required regulations and standards.

REGULATORY AUDITING

JMG3 CAN implement regulatory auditing SOPs, forms, etc. to properly host and participate in regulatory audits.

If needed, JMG3 CAN be onsite for the regulatory audit to serve as your quality liaison throughout the inspection.  NOTE: May not be possible to be physically present during all audits due to some audits being unannounced.  It may be possible to be present via phone/online meeting platform.

JMG3 CAN handle your response needs to the regulatory agencies.

EXTERNAL AUDITING

JMG3 CAN implement external auditing SOPs, forms, etc. to properly host and participate in external audits.

JMG3 CAN handle your response needs to the suppliers / external agencies.

JMG3 will implement Supplier Qualification SOPs, forms, etc. to properly vet Suppliers and conduct Supplier audits.  We will ensure you have your all of the completed documentation for each Supplier and an Approved Supplier List.

JMG3 CAN perform all of your Supplier Qualifications to ensure you have approved suppliers that you do business with as this is an FDA requirement.

JMG3 CAN perform desktop audits of these suppliers or go onsite to perform the audits.

JMG3 will create the Approved Supplier Audit Schedule and if JMG3 is providing Ongoing Quality Support for you, then we will perform the audits prior to their due date.

See Event Handling section for SCARs.

JMG3 CAN perform most validations and qualifications required by the FDA for Eye and Tissue Banking Establishments.  JMG3 will design and perform the protocol and complete the final report.  Some testing will need to be sent to laboratories or other companies qualified to perform the testing.  All information will be gathered, reviewed, and added to the overall validation package for you.

• Tissue Shipper Validations
• Tissue Product Packaging Validations
• Processing Validations
• Temperature Monitoring System Validations
• Cleanroom Validations
• Printer Validations
• Refrigerator Qualifications
• Freezer Qualifications
• Sterilizer Qualifications
• Product Sterilization Validation
• Etc.

EVENT HANDLING

JMG3 CAN implement all of the needed SOPs, forms, and logs needed to establish and maintain a strong event handling system.  The event handling system includes Non-Conformance Reporting, Corrective and Preventive Actions (CAPAs), Deviations, Supplier Corrective Action Reporting (SCARs), Complaints, Adverse Reactions, HCTP Deviation Reporting, Reportable Event Notifications, Failure Modes Effects Analysis (FMEAs), Health Hazard Evaluations (HHEs),  etc.

JMG3 CAN manage the Event Handling System for your establishment.

REPORTING

JMG3 CAN provide you with procedures on all applicable reporting needs to all of the agencies that pertain to your establishment.  

JMG3 CAN help with your reporting needs, whether changes to your company, annual registrations, Adverse Reaction Reporting, HCTP Deviation Reporting, etc., JMG3 is here to help.

JMG3 will provide a comprehensive suite of SOPs, forms, logs, templates, etc. that will be needed to start and manage your tissue bank's quality department and operations.  The documents will be separated into several modules that are tailored to your establishment.  

The Document Control System can be paper based or designed to work with a Document Control Software System.

A comprehensive training program will be set up with SOPs, training matrices, training plans for positions, verification of effectiveness documents, etc.

Training folders will be set up for each current staff member or reviewed if already set up to ensure that they contain all required documentation and are current.

Training for quality related procedures and documents will be provided to quality staff.  Operations procedures can be provided depending on the agreement.

JMG3 CAN set up your establishment to ensure you are compliant with the applicable federal, state, and accreditation agency regulations and standards.

Your establishment will take it from there  to keep you in compliance or retain JMG3 and we CAN help manage your quality management system to keep you in compliance.