Quality Metric KPI: Assessment, Monitoring & Continuous Improvemeent

Assessment of Current Capture Points, Recording and Reporting Models - Each aspect of on site metrics are assessed to determine the effectiveness of current definitions used by your organisation in terms of identifying trends for improvement / mitigations as well as complying with quality standards as per ISO & ICH:

  • CAPA and Deviation Analysis
  • Failure Investigation Breakdown
  • Complaints Trend Review
  • Quality Control Out of Specification / Trend Analysis
  • Operations Excellence Monitoring Effectiveness
  • Audit Data Drill Down Analysis
  • Assessment Reporting with Mitigation Action Plan - Full reporting on the state of the current metric system including reporting compared to the success rate of determining root cause of chronic / acute issues within the organisation:

  • Quality System Improvements
  • Corporate Metric Definition Review and Findings
  • CAPA & Deviation Root Cause Analysis Review and Findings
  • Complaints Trends, Reporting & Analysis
  • Quality Assurance, Control and Operation Excellence Efficiency Findings
  • Drill Down Findings for Operations / Productions
  • Final Summary and Recommendations to change, improve on site systems and mitigate regulatory risks
  • Review and / or Design of Metric Excel & Custom Tools - Solutions to meet the defined mitigations and recommendations for improvement of onsite metric program so that it is truly fit for purpose in identifying true issues as well as ensuring quality management systems compliance as per ISO and ICH:

  • Streamlined entry and visual review of quality and operations trends
  • Automation of reporting from metric reporting sources
  • Projection automation based on corporate and quality system targets / compliance goals
  • Customisation of current implemented tools for metric monitoring and reporting including tool validation
  • Custom Project Development Services

    We welcome custom queries to help anyone regarding any potential project and related issues. We will work with you and put our expertise forward with you to help you achieve your goals. MCP is engaged in multiple sectors within and outside the GxP sciences sector so we will do our best to help

    Patrner Consulting

  • Working as a team is the major basis of success. As such it is our policy to develop partnerships with other consultants and corporations in order to bring forward better changes and developments for clients and patients
  • Medical Device Design

  • Using Solidworks, design conepts and testing are coducted to test out novel solutions to current restraints and demands of medical device design
  • Inhouse Research for Novel Project Creation

  • Our team are constantly research current and new fields of research and development looking for market gaps and demands. Using this as a starting point - we focus on the development of feasable deliverable solutions that are novel in design and implementation
  • Project Development & Management

    We provide project management & development support from start to finish. Our projects range from fresh GMP implementation for the pharmaceutical & electronic cigarette industry, regulatory compliance and novel product / process development. We also do project intervention support. The following below is some of the current projects we are working on with clients:

    Clinical Trial Intergration

  • Automated Clinical Trials & Tele Medicine - Automated data aquisition at every stage to ensure accuricy and efficiency in a trial setting that required the best of safety and efficacy. The aim of this project is to offer a long term efficient change ready solution for clinical trials at any stage. Taking the above into account - this solution based system for fully automated data recording and entry coupled with EDMS connecting trial sites and trial management centres is fully scaled to the particular trial stage and size. The following aspects are the basis points for intergration
  • Mobile Diagnostic Application Development

  • The development of fully approved diagnostic mobile applications coupled with patient feedback capability where needed will allow for real time data aquisition of patient health data and patient feedback. The low cost deployment of a mobile app allows for widespread use without the additional costing of a medical device.
  • Web Frontend / EDMS Backend Development

  • A centralised web portal facility for front end access to the EDMS backend will allow companies full management and access to realtime and visit data with fully complient document control and management while also ensuring alert systems for AE and SAE (adverse and serious adverse events) beyond the patient visit.
  • Test Laboratory Proposal - Regulatory Testing for E-CIG Industry

  • Mythen Coprorate Projects is currently working with consultants and a leading e-cigarette producer to develop a regulatory implementation plan coupled with a finalised test laboratory proposal. This roadmap and proposal is vital to ensure that regulatory production and testing standards are in place ahead of the anticipated regulatory and legislative implementaion by the US FDA and the various EU Regulatory Agencies and/or EU Legislative Bodies.
  • 21

    Continious Improvements Completed

    20

    KPI: Assessed/Updated Per Project

    53

    KPI: SOPs Assessed/Updated Per Project

    109

    Deadlines Achieved