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OC11Systems - One Solution One Validation
eQMS - QUALITY MANAGEMENT SYSTEM
SOPs, Training, Change Control, Deviation, CAPA, Investigations, Complaints, OOS, etc.
MANUFACTURING
Batch Records, Annual Product Review, Log Books, Forms, etc.
PACKAGING & LABELING
Packaging Record, Label Control, Forms, etc.
LABORATORY CONTROL
Log books, Lab Note Book, Monographs, Forms, etc.
MATERIAL
Log Books, Certificate of Analysis, Product Specifications, Forms, etc.
FACILITIES & EQUIPMENT
Calibration, Maintenance, Validation, Log Books, Forms, etc.
One Computer System Validation
Word Processing - OC11Systems
- Data Integrity ALCOA+ Controls
- 21 CFR Part 11 Compliance
- Cloud-Based
- Proven Innovative One Validation System Concept - Inspected by Regulators
- Any regulated data created in the word processing system