QUALITY SYSTEM SOLUTIONS
Accurate FDA Consultants will immediately supplement your organization to provide various quality system solutions, which will comply with FDA and the appropriate International Regulatory Authorities regulations and standards.
Accurate FDA Consultants can engineer and supply you with the appropriate FDA compliant documentation and training. Our Quality System solutions can be customized and implemented correctly into your organization for sustainability.
Medical Devices/IVDs:Accurate FDA Consultants can prepare and implement the entire system or advise on a specific subsystem to meet the FDA QSR compliance (21 CFR 820: Quality System Regulation).
Our quality system program for medical device and IVD manufacturers focus on the proper implementation and sustainability of the following seven major subsystems:
1) Management Controls
2) Design Control
3) Corrective and Preventive Action (CAPA)
4) Production and Process Controls
5) Document Controls
6) Purchasing and Material Controls
7) Facility and Equipment Controls
*Medical Device Reporting- 21CFR Part 803
Pharmaceuticals/Biologics: Our approach to cGMP quality system implementation for biologic and pharmaceutical manufacturers (21 CFR Part 210 and 211) complies with FDA’s Compliance Program 7356.02.-A System Based Inspection of Drugs and focuses on the proper implementation and sustainability between the following six systems:
1) Quality Systems
2) Facility and Equipment Systems
3) Material Systems
4) Production Systems
5) Packaging and Labeling System
6) Laboratory Control System
Cell and Tissue Therapy: Accurate FDA Consultants can assess, prepare and implement a system compliant Good Tissue Practices (GTP) Quality System (21 CFR Part 1271) or reengineer your current system for improvement and sustainability.
Contact us today for a non-obligatory consultation and quote. Let’s discuss your needs and scope of any quality system implementation or improvement project.
- Enterprise Risk Strategy and Emerging Technologies to address critical needs
- 3D Printing Medical Device Manufacturing= Additive Manufacturing
- FDA Issues New Import Data Requirements
- Compliance Dates for UDI Regulatory Requirements
- Strategic and Effective FDA Pre-Submissions
- Addressing FDA Import Alert and “Notice of FDA Action”