When Lean Compliance can help you
Lean Compliance can help if you are undertaking nearly any compliance and/or quality initiative such as:
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Implementing, improving, or centralizing a quality system
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Addressing compliance issues like CAPA, complaints, risk management, or supply chain
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Preparing for or remediating after regulatory inspections
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Validating processes, equipment, test methods, or software
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Developing a new product or process
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Commissioning and qualifying new facilities
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Addressing CE Mark technical file/design dossier recertifications, submissions, or updates
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Reducing the cost of quality
About LCS
The Lean Compliance System™ (LCS) tools are the result of over 25 years of witnessing significant waste in the way quality and compliance initiatives are traditionally addressed. The common practice of hiring outside consultants and contractors is grossly inefficient and costly due to inadequate management controls for scope, risks, decision making, resource allocation, resource costs, schedule, and expenses. The LCS utilizes embedded Lean Six Sigma principles, industry best practices, and proven program management techniques to deliver a right-sized solution that will stand up to stringent regulatory scrutiny.
Key Elements of Lean Compliance
Typical LCS Project Solutions
- Cost of Quality
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Warning Letter Remediation
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Risk Management Practices
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CAPA/Complaints
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Supplier Quality
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Validation (all forms)
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New products/Facilities
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QMS/QSIP
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Cost of Quality
To learn more about Lean Compliance, download an overview or contact Maetrics today for a no obligation discussion of how we can help you achieve Lean Compliance.
