Friday, May 09, 2008
FDA COMPLIANCE SOLUTIONS SERVICES
OUR HIGHEST QUALITY, COST EFFECTIVE SERVICES
FDA Compliance Solutions, Inc. offers a unique combination of significant and creative solutions to provide for your regulatory compliance needs. We offer services that provide both turn key solutions and the tools to make you independent and self-sufficient.
Our solutions and services include:
- Computer System Validation
- Master Validation Planning
- Process Validation
- Methods Validation
- Risk/Hazard Assessment
- Gap Analysis
- Medical Device Registration-510(k)s/PMA’s
- Blood/Plasma Software Validation and Registration
- Computer System and Process Validation Training
- GMP, GLP, QSR, PDMA Training and Certification
- Validation Process-SOPs, Polices, Checklists, Protocols,
- System Qualifications: IQ, OQ, PQ, and DQ
- Trace Matrix
- System Testing and Test Planning
- Requirements Planning
- Compliance Auditing and Planning
- FDA Representation
- Commissioning
- Software Analysis and review
- VendorAuditing
- Training Qualification and Management
- Project Management
- Compliance Outsourcing
- FDA Citation and Consent Decree Support
- Customized services and support
ASK ABOUT OUR INDUSTRY UNIQUE WARRANTY
Call Phil Sax at 856-216-1516 to discuss how we can help.
PhilSax@FDAComplianceSolutions.Com