Providing the following services
21CFR Part 11 Compliance and Validations (computer/software/V&V) - ISO 9000, 9001, 9002 cert. preparation - QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC compliance - Industrial Hygiene, fed. & Cal. OSHA - Design Controls, DHF, and Engineering Documentation - Product Transfer from R&D to Manufacturing - FMEA, FTA, Design Dev. and Hazard Analysis - Document / Design History File development - MRP / ERP system development & implementation - SPC / SQC and statistics (clinical, manuf., R&D) - Metrology and other Calibration services - Preventive and Emergency Maintenance Plan - Validations (equipment, process, PLC, sftwr., etc.) - Professional Speaking, Seminars and Training
I will help you:
1. Increased inter and intra-departmental performance. 2. Reduced wasted capital, time and effort. 3. Increased Customer Satisfaction. 4. Increased Profit. |