Maetrics Lean Compliance System E Version
- 1. Lean CompLianCe SyStem™ Lean Compliance is an innovative Maetrics™ program focused on improving quality and reducing costs for businesses subject to FDA or other global regulatory entities. The foundation of Lean Compliance is a robust set of tools called the Lean Compliance System (LCS™). These tools are based upon Lean Six Sigma principles, embedded industry best practices, and robust program management techniques that can be rapidly deployed and implemented. www.maetrics.com
- 2. WhEN LEaN CompLiaNCE CaN hELp YoU aBoUT LCS Lean Compliance can help if you are undertaking nearly any compliance and/ The Lean Compliance System™ (LCS™) tools are the result of over 25 years or quality initiative such as: of witnessing significant waste in the way quality and compliance initiatives • Implementing, improving, or centralizing a Quality System are traditionally addressed. The common practice of hiring outside • Addressing compliance issues like CAPA, Complaints, Risk Management, consultants and contractors is grossly inefficient and costly due to inadequate or Supply Chain management controls for scope, risks, decision • Preparing for or remediating after regulatory inspections making, resource allocation, resource costs, • Validating processes, equipment, test methods, or software schedule, and expenses. The LCS utilizes • Developing a new product or process embedded Lean Six Sigma principles, industry • Commissioning and qualifying new facilities best practices, and proven program management • Addressing CE Mark Technical File/Design Dossier recertifications, techniques to deliver a right-sized solution that submissions, or updates will stand up to stringent regulatory scrutiny. • Reducing the cost of quality KEY ELEmENTS oF LEaN CompLiaNCE MAnAgEMEnT ConTRoLS & CoMMunICATIon TEChnICAL oRgAnIzATIonAL & buSInESS goALS SuSTAInAbILITy • Learn improvement Roadmap • timeline, resource, and risk • tools to manage future outcomes • Detailed program plan and budget management • identification of cultural changes • Stated compliance goals • Harmonization of project tasks that sustain progress • Stated revenue goals & activities • effective 360° communication • identification, development, and delivery of effective training www.maetrics.com
- 3. $ 30 pERCENT LoWER CoSTS outside consultants can be expensive and are often utilized inefficiently. The LCS leverages embedded industry best practices and proven techniques for managing diverse resources at multiple sites to quickly accomplish a wide variety of initiatives. ultimately, the LCS ensures that your quality and compliance environments and business needs are integrated into one harmonized solution that ensures high quality and lower long-term operating costs. BENEFiTS oF LCS pRoGRam maNaGEmENT Effectively managing quality or compliance initiatives is critical to achieving your desired business goals. LCS program management techniques are designed to protect you from cost and schedule overruns while ensuring that results are sustainable. Proven LCS program management techniques provide this value and confidence through: • Rapid start-up, shorter duration, reduced costs • Effective risk management • Rigid control of scope • Contingency plans for unexpected visits from regulatory agencies • Management of decision making processes • Effective management of the team and team dynamics • Visibility of post project costs for maintenance and control • Ability to track and report daily, weekly, and monthly Key Performance Indicators (KPIs) via an electronic dashboard configured to your needs Contact Maetrics today for a no obligation discussion of how Maetrics can help you achieve Lean Compliance. Maetrics, LLC | 8888 Keystone Crossing, Suite 1550 | Indianapolis, In 46240 | 877.MAETRICS (623.8742) | 317.706.1493 www.maetrics.com © 2011 Maetrics, LLC. All Rights Reserved.