Quality Systems & Compliance Consulting

MBC & Associates provides innovative quality system and regulatory compliance solutions that improve performance, eliminate inefficiencies, and increase compliance.

Customized, Practical Solutions

Quality and compliance do not come sold in a box. Companies need real world guidance, not textbook answers. Advice must be practical for the specific situation. MBC & Associates provides real world answers that come from our breadth and depth of experience.

Our extensive list of Quality System and Regulatory Compliance services provides just the start for designing a custom solution for your business needs.


Our Services
Quality Assessments & Auditing

We provide complete assessment and audit reports including detailed recommendations for system improvement, ways to reduce regulatory risk, and increase business efficiency based on industry best practices.

Some of the services we offer are:
  • Quality System & compliance assessments
  • Development and management of Internal Quality Audit programs
  • Development and management of Supplier Quality Audit programs
  • FDA QSIT, ISO 13485, ISO 14971, and ISO 9001 assessments & audit preparation
  • MDD, IVDD, CMDR, and  FDA Part 11 assessments & audit preparation
  • Mock FDA Inspections
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Quality System Design & Implementation

We offer comprehensive quality system and regulatory compliance leadership for the creation or re-design of quality systems.  We work closely with your team to develop and author individualized quality system policies and procedures to enhance your compliance efforts and support your specific business needs.

Some of the services we offer are:
  • Quality System design & deployment
  • Quality System gap analysis & re-engineering
  • Document and Change Control business systems
  • Data & Records Management business systems
  • Design Control strategies & process development
  • Development and implementation of CAPA programs
  • Development and implementation of Complaint Handling systems
  • Nonconforming Material programs & management
  • Process Validation programs & assistance
  • FDA Facility Registration assistance
  • Recall & Field Correction assistance
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Software Configuration, Validation & Implementation

We support clients throughout the process of automating business processes through Off-the-Shelf software applications.

Some of the services we offer are:
  • Defining system requirements and assisting in the preparation of Requests forProposals & Quotes (RFP & RFQ)
  • Assistance in selecting appropriate software applications to meet individual compliance needs and business goals
  • Development of functional and technical specifications for software applications
  • Configuration of software applications to meet individual business processes
  • Software Validation (IQ, OQ, PQ)
  • Assistance with document and data migration
  • Technical IT support
  • Software application integration
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Project Management

Effective project management is critical to the success of any quality system implementation or re-engineering effort.  We offer comprehensive project management services for the complete life-cycle of the implementation or re-engineering effort, including PM support for any software application configuration, validation, and implementation efforts.  We work closely with your implementation team to ensure the project is completed with the highest quality, on time, and within budget.

Project management professional services include:
  • The Project Manager assigned to the project will work closely with the client’s implementation team to define and document major tasks, milestones, deliverables, timelines, and resources needed to successfully complete the project.
  • S/he will act as liaison between implementation personnel, management, and vendors by conducting meetings to review project details and obtain necessary reviews and approvals.
  • S/he will monitor all phases of the project, review status reports, and modify schedules or plans as required.  The Project Manager will also prepare regular project reports for the client and other defined stakeholders.
  • The Project Manager will confer with project personnel to provide technical advice and to resolve issues.
Project Management >>


Regulatory Compliance Training

We will assist you in developing an efficient and compliant training system that works for your business.  Additionally, we can create customized training courses designed specifically for audiences ranging from the executive board room to manufacturing operators/technicians to field service personnel.

Some of the customized training services include:
  • Instructional design
  • Content development
  • Expert delivery in a variety of class formats
  • Testing and/or evaluation of effectiveness
  • Certificates of completion or training records, as appropriate
Regulatory Compliance Training >>


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