Quality System Management
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BRC Clients: Drug Companies, Device Companies Analytical Laboratories & Clinical Research Organizations
Quality Management System...
...an expectation of Sponsors and Regulators

Commonalities: Core management principles that pertain directly to business policies, procedures and efficient operations and that therefore yield high quality products and services are common across biomedical organizations. These principles integrate as a system of quality management (e.g., ISO 13485: 2016), and include at a high level:​​ 
  • Regulatory Compliance
  • Accountability
  • Standard Operating Procedures
  • Training
  • Documentation
  • Record Control
  • Traceability
  • Investigations and Corrective Actions
  • Application of Customer Feedback
    (among other stipulations in ISO 13485)
Quality Management System (QMS): A QMS is formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management. (ASQ)

Sector Differences: Different sectors of the biomedical community will have discipline specific differences. For example, an analytical research lab will generally rely on Sponsors and CROs to be responsible for Informed Consent, just as Sponsors and CROs rely on the lab for method validation. Nonetheless, the core QA principles of a QMS are common to all.  
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BRC Services: The BRC team understands all sectors of the biomedical community by our training and experience, and as evidenced by our ongoing QA services for drug, device, CROs and analytical labs. 
Contact BRC: Bill Soller at 713-447-2004
[email protected]​
​A Readiness Mindset- The BRC Value

Training and Experience: Our value to each of our clients is the application of our training and experience across the different types of biomedical organizations, so each client adopts and sustains an audit readiness mindset.

Successful Application to Meet Regulatory Expectations: We understand and have successfully applied our knowledge of regulatory expectation that every regulated company is to have a robust Quality Management System. 
  • ​Current Repeat-Client Feedback, relating to our work on renovating QM Systems for our clients: 
    • "Thank you, Bill. Thanks for being predictably there for us. I value your contributions highly." From: CEO of a Clinical Research Organization. 
    •  "Bill, I really appreciate you. I value your advice." From CEO of a Medical Device Company.
Audit Readiness as a Mindset
  • Readiness:  State of preparedness of persons, systems, or organizations to meet a situation and carry out a planned sequence of actions. Readiness is based on thoroughness of the planning, adequacy and training of the personnel, and supply and reserve of support services or systems.*
Client Services to Achieve a Readiness Mindset: 
  • ​Internal Audits for Gaps Analysis to identify QMS vulnerabilities, using proven approaches that model FDA inspections and/or Sponsor audits.
  • Renovation of client QMS to ensure efficient, uncomplicated approaches to streamline QMS responsibilities and associated activities.
  • Training personnel - QMS, Part 11 compliance, Good Documentation Practices, preparing an Annual QA Strategic Plan, mentoring QA personnel, among other training. 
  • Preparation for FDA Inspections.
  • Preparation for Sponsor audits.
  • Engagement at the QA Oversight Entity to build the QMS, and create Master File system applicable to the type of company.
Success Story: Three current clients approached BRC to undertake a QMS Gaps Analysis, that yielded recommendations on new SOPs, revisions to current SOPs, adoption of a Quality Management Committee, a Master File system, document control, record retention, and an Internal Audit Schedule. Each of these companies, which have QA personnel, moved forward with the BRC recommendations, and further retained BRC to oversee the successful adoption of a readiness mindset by their QA and Operations people.

Two of the three companies continues to retain their relationship with BRC, which now fulfills their needs for Director-level QA for QA and Regulatory Compliance. 

*http://www.businessdictionary.com/definition/readiness.html (accessed: February 15, 2019).
Contact BRC: Bill Soller at 713-447-2004
[email protected]

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