Quality system consulting is our main niche! We specialize in designing, building and implementing quality systems for organizations of all sizes across the Life Sciences industry. We are very flexible in the types of services we provide, from smaller limited assignments to long-term complex projects. We have expertise with U.S. & international regulatory requirements, as well as a multitude of ISO standards. As such, one of our primary specialties is designing, building and implementing “Integrated QMSs”. An integrated QMS is one that satisfies the requirements of multiple ISO standards and/or regulatory requirements.
We will work within your organization to create, develop, and/or improve your quality system 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.
We can dramatically improve your Root Cause Analysis (RCA) process through the utilization of our proprietary tools. However, if you require our assistance in providing RCA training to your employees or actually identifying the source of your problems and developing appropriate corrective actions, we can do that as well.
Multiple services are available from EMMA International regarding implementation of statistical process controls, inspection plans, and valid acceptance criteria. We can help you develop and maintain adequate Device History Records (DHR). We have extensive experience in addressing manufacturing quality issues, from receiving inspection to functional testing requirements.
We have the expertise to provide you with effective design and process validations, from a complete validation process implementation including a unique, customized Validation Master Plan to actually developing individual validation plans, conducting the validations, and writing the final validation reports and supporting documentation.
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 will identify your systemic quality problems.
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.
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).
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.