Quality

Our experienced Quality consultants can help ensure that your Quality Management System is helping your business and not hindering it. We will review your existing Quality Manual and Procedures for conformance to the regulations and standards you require, or help you to create a Quality Management System to meet your requirements. In particular using ComplianceControl Centre can help to automate your processes including:

  • Documentation
  • Change Control
  • CAPA/Deviations
  • Customer Complaints
  • Auditing
  • Training Records

Definitions of Quality

In manufacturing, a measure of excellence or a state of being free from defects, deficiencies, and significant variations, brought about by the strict and consistent adherence to measureable and verifiable standards to achieve uniformity of output that satisfies specific customer or user requirements.

Manufacturing-based definitions are concerned primarily with engineering and manufacturing practices and use the universal definition of “conformance to requirements.” Requirements, or specifications, are established design, and any deviation implies a reduction in quality. The concept applies to services as well as products. Excellence in quality is not necessarily in the eye of the beholder but rather in the standards set by the organization.

Put simply…. Quality is the level of adherence to good procedures. If a simple set of procedures can be put in place, and staff trained accordingly, then the defined processes should produce quality products and/or services.

Failure to create appropriate procedures, lack of initial, and on going training, and poor internal auditing processes will eventually lead to poor quality products and services.

Where an organisation produces products or services that must comply with regulations, the level of quality of the organisation is defined by the level of procedures in place to ensure conformance to the set of regulations that must be followed. Adequate staff training regarding the operational procedures, combined with good internal auditing, and a simple and effective CAPA (Corrective Action, Preventive Action) system, will ensure compliance.

A simple Deviation Management System process, including investigations from customer complaints should drive root cause analysis investigations, thus improving overall quality.

Key Performance Indicators to provide visibility and to demonstrate the level of Quality of an organisation is difficult using a paper based system. Electronic Quality Management Software and Regulatory Compliance software, such as Electronic Quality Management Systems and Electronic Document Management Systems, provide visible KPI’s to management. Staff using Information Management systems to help follow Quality Processes and Procedures can help to improve visibility and levels of quality.



     
     

Customer References

  • I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project. CFO, Major Pharma Company
  • Compliance Controls Consultants brought immediate expertise to our team as part of our drive into the European market. Vice President, Research & Development, Pharma Company
  • We wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements. Business Development Manager, Phama Company
  • I would like to personally express my great appreciation for all your excellent work and great support with the validation of our IT infrastructure and software. Managing Director, Compounding Centre, UK
  • ComplianceControl Centre was selected because it is easy to use, quick to set up, and was a validated, cost effective solution for an organization of our size. We wanted a system that we could rapidly implement. Vice President, Research & Development, Pharma Company
  • Working with Compliance Control Consultants and their software products ComplianceControl Centre and cGARD helped us to understand the regulatory requirements of IT and business systems more clearly. IT Director, Pharma company
  • Using ComplianceControl Centre will help us to ensure that we are always inspection ready, by tracking our critical Quality and Compliance activities. Vice President, Research & Development, Pharma Company
  • It has been a pleasure working with you and your team and I am looking forward to co-operating with your company on similar projects in the future. Managing Director Compounding Centre UK
  • Based on your achievements and delivered results, we have started the process of building up our internal team for continuation of the work started by you. Managing Director, Pharma Company
  • cGARD has become the new rage here ! Sr. Manager, Documentation and Training, Major Pharma Company

 

 

    

 




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