Compliance Management Systems Creation & Maintenance
The services and solutions you need to oversee your manufacturing business is more important than ever with changing regulations and increased competition. Our services include sharing our in depth industry knowledge and experience to deliver project-wide, plant-wide or company-wide compliance management and quality management that are cost effective and distinct to your company’s operations, values, business focus and culture. We provide professional guidance for meeting FDA requirements and international standards. EXL Laboratories, Inc. believes that this approach to system regulatory compliance consulting produces the highest level of quality and service for our clients.
EXL Laboratories, Inc. offers Compliance Services for FDA and international regulations including:
* 21 CFR Parts 111 Compliance for Dietary Supplements
* 21 CFR Parts 210 and 211 Compliance for Finished Pharmaceuticals
* 21 CFR Parts 11 Compliance for Electronic Records and Electronic
Signatures
* 21 CFR Part 820 Quality System Regulation for Medical Device
* EU Annex 11 Computerized Systems
* ISO 13485 Medical Device Standard & ISO 14871 Medical Device Risk
Management
* sFDA Good Manufacturing Practices for Drugs
* Audit Services
* Compliance Assessment and Gap Analysis
* Mock Inspections and Pre-Approval Inspection Readiness Reviews
* Product Corrective Actions Preventative Actions
* Regulatory Inspection Assistance
Pharmaceutical companies are required to develop and use effective monitoring and control systems to ensure product quality and capability of the process through the product development life cycle. ExL Laboratories Inc. provides experienced staff to ease the process of building a quality system. Our experts have in-depth understanding of ICH Q1A to ICH Q10, GMP, ISO 9000:2005 and have extensive experience building and implementing Quality Systems. We can help you with all aspects of building or improving your Quality System from writing your Quality Manual through providing resources to implement and maintain your systems to assisting with the structure of Management
Reviews to ensure that your senior management team is appraised of your system in a concise and expeditious manner. A correctly designed and implemented Quality System will facilitate continuous improvement and ensure effort and resources are focused appropriately proportionate to
risk.
We offer a full range of Quality Systems services, including the following:
* Corrective Action and Preventive Action (CAPA) System
* Process Performance and Product Quality Monitoring System
* Change Management System
* Management Review of Process Performance and Product Quality
* Standard Operating Procedures
