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Quality Management System (QMS) Development and Deployment

1. Service Description

We develop and deploy customized robust Quality Management System (QMS) adhering to any of the regulatory standards of your choice with minimal time and cost.

There will be productivity increase and cost savings of more than 60% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

We will

  1. Implement QMS based on ISO 9001:2000, ISO 13485:2003, FDA Quality System Regulation Title 21 CFR Part 820, 210, 211 etc.

  2. Identify general compliance expectations of the FDA, EU and local authorities for medical device and drug manufacturers

  3. Identify the key points of the Quality System Regulation

  4. Complete an initial "gap analysis" of what's new/different in a regulated industry

  5. Identify the technical and non-technical requirements for organizational readiness for effective QMS implementation

  6. Identify a problem in standard interpretation; be able to resolve it to meet compliance

  7. Identify factors to consider when planning a QMS implementation: organizational environment, human elements, business objectives, and costs

  8. Identify cost saving and business value of registration to a QMS standard for the organization

  9. Identify role of important quality and productivity methods such as Six Sigma, Lean, Baldridge, and Balanced Scorecard in a QMS

  10. Identify tools that can assist and improve QMS implementation

  11. Identify metrics to assess implementation success

  12. Identify ISO/EU/FDA audit process, including QSIT, QSR "satellites" and Part 11 compliance issues

The service also provides correlation between different standards, applicable clauses and gap analysis. The quality management system service will establishes policies and requirements that apply to organizations employees, facilities, products and services involved in the design, manufacture, test, distribution, installation and servicing of products intended for use. The quality management system designed will ensure that products are safe and effective and to prevent nonconformance's at all product stages from design through servicing.

Enterprise Quality Management System

Figure 1 - Enterprise Quality Management System

Process Based Quality Management System Model

Figure 2 - Process Based Quality Management System Model

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings ≥  20% ≥  40% ≥  60%
Annual Sales ≤ $100 million $100 million < Sales ≤ $500 million > $500 million
Number of Submissions ≤ 2 per year 2 < Sub ≤ 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach

  1. Your customized organization quality management system will define the:
  2. Quality Manual
  3. Corporate Standard Operating Procedure (CSOP), Site Specific Procedures, Work Instructions, Forms etc.
  4. Processes needed and their application throughout the organization
  5. Sequence and interaction of these processes
  6. Criteria and methods needed to ensure that both the operation and control of these processes are effective
  7. Availability of resources and information necessary to support the operation and monitoring of these processes
  8. Methods for monitoring, measuring, and analyzing these processes and
  9. Methods for implementing actions necessary to achieve planned results and maintain the effectiveness of these processes.

Quality Management System Documentation

Figure 3 - Quality Management System Documentation

Quality Management System with coordinated activities

Figure 4 - Quality Management System with coordinated activities

4. Definitions

Quality Policy: Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

Quality System: Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

What is Title 21 CFR Part 820?

In 1997, the FDA revised its current Good Manufacturing Practices (cGMP) to harmonize the requirements and terminology with the international standards (ISO 9001:1994 and ISO 13485:1996) and renamed it the Quality System Regulation. The QSR includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing medical devices intended for human use.

Will the FDA certify the Affymetrix Quality System for compliance to the 21CFR Part 820?

The FDA does not certify a company's quality system. However, they do inspect companies that design and manufacture medical diagnostic devices. The inspection could include a review and evaluation of a company's quality system processes and procedures and quality system records related to the diagnostic products. If the FDA Inspectors observe any areas of non-compliance to the applicable regulations they will issue an FDA Form 483, which the company will be required to address.

5. Applicable Laws, Regulations and Standards

Some of the regulatory standards for which we have developed quality management systems are as below:

  1. ISO 9001 – Quality Management Standard
  2. ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  3. Global Harmonization Task Force (GHTF). (2008). Principles of Conformity Assessment for Medical Devices
  4. Title 21 CFR Part 820 – Quality System Regulations
  5. Title 21 CFR Part 803 – Medical Device Reporting
  6. ISO 14971– Medical Devices – Application of Risk Management to Medical Devices
  7. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In-Vitro Diagnostic Medical Devices (The IVDD)
  8. Title 21 CFR Parts 210 and 211 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs.
  9. ICH Q7A - Good Manufacturing Practice for Active Pharmaceutical Ingredients http://www.emea.eu.int/pdfs/human/ich/410600en.pdf  
  10. Title 21 CFR Part 11 – Electronic Records and Electronic Signatures
  11. ICH E6 – Guideline for Good Clinical Practice - http://www.emea.eu.int/pdfs/human/ich/013595en.pdf 
  12. ICH E8 – General Considerations for Clinical Trials - http://www.emea.eu.int/pdfs/human/ich/029195en.pdf
  13. ICH E9 – Statistical Principles for Clinical Trials - http://www.emea.eu.int/pdfs/human/ich/036396en.pdf 
  14. Clinical trials with medicines in Europe -  http://www.efpia.org/6_publ/document/clinical.pdf
  15. EU Clinical Trial Directive on medicinal products for human use - http://eudract.emea.eu.int/docs/Dir2001-20_en.pdf
  16. Title 21 CFR Part 58 – Good Laboratory Practice for Nonclinical Laboratory Studies
  17. ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary
  18. ISO/TR 14969 – Medical Devices – Quality Management Systems – Guidance on the Application of ISO 13485
  19. PCAOB - Accounting Regulator created by SOX: http://www.pcaobus.org/Standards/index.aspx
  20. Financial risk management standards - http://www.coso.org/  
  21. AICPA - Industry group for CPA's, formerly self-regulating. PCAOB took over some of the standards formerly set by AICPA: http://www.aicpa.org/  
  22. ISACA - IT Audit & Risk management to support AICPA, issues COBIT - http://www.isaca.org/
  23. PCI Credit card processing - https://www.pcisecuritystandards.org/