Our quality systems consulting experts will work within your organization to create, develop, and/or improve your processes.
• Is your system inadequate?
• Is it too complex to be effective?
• Are you overwhelmed with CAPA problems that are overdue for corrective actions?
• Do your CAPA teams have trouble finding the true root causes of problems?
These issues result in more FDA Warning Letters’ findings than any others. We will develop, improve, and simplify the CAPA process to make it the effective, value-added process you believe it should be.
Problem Solving
We can dramatically improve your Root Cause Analysis (RCA) process with our proprietary tools. If you need help providing RCA training to your employees or identifying the source of your problems and developing appropriate corrective actions, we can do that as well.
Manufacturing QA/QC
Multiple services are available from EMMA International regarding implementation of statistical process controls, inspection plans, and valid acceptance criteria. We help you develop and maintain adequate Device History Records (DHR). We have extensive experience addressing manufacturing quality issues, from receiving inspection to functional testing requirements.
Validation
We have the expertise to provide effective design and process validations. Notably, we provide a complete validation process implementation including a unique, customized Validation Master Plan and develop individual validation plans, conduct validations, and write the final validation reports and supporting documentation.
Quality Audits
Is your Internal Audit process inadequate in identifying significant quality and regulatory issues? Is your internal audit function chronically behind schedule? We can fix your audit process, train your auditors, and help you adhere to your audit schedule. Additionally, we provide complete independent audits for all functions and requirements. We can provide an effective audit to all ISO, EU, QSR, CMDR, GMP, GLP, and/or GCP standards and requirements. A final report will be provided that not only meets your regulatory requirements, but identifies your systemic quality problems.
Customer Complaint Handling
The effectiveness of a complaint system is not only a major focus of FDA scrutiny; it is a sometimes-neglected or under-utilized source of potential revenue. Addressing customer complaints, fixing design or production issues, and identifying trends to prevent small customer problems from becoming major sources of dissatisfaction all contribute to your bottom line. We can help you make your complaint handling system more effective and thereby increase your profits.
Design Controls
We will work with your R&D staff to develop practical and effective design requirements, validations, and Device Master Records (DMR) as required by FDA. We will help you produce adequately safe and reliable products through implementation of valuable Failure Mode and Effects Analyses (FMEA) and Fault Tree Analyses (FTA).
Supplier Quality
This is a relatively new focus of FDA, and an area that has been neglected by many Life Sciences companies. We have the expertise to implement supplier qualification and approval/disapproval processes, including a supplier assessment process. Let us conduct your supplier audits for you. For a very reasonable cost, we can fulfill this regulatory requirement and provide valuable information concerning the quality and reliability of your suppliers and their products.