If you need help with determining what to validate, when and how to do it, or a review of your current validation, we use a risk based approach to validate your systems. We do that any new computer system validation effort with the below requirements.
- GAMP5 risk-based software life cycle development model.
- FDA 21 CFR Part11 on electronic records, electronic signatures.
- PIC/S Annex 11 on validated computer systems.
ICCON Consulting provides a variety of consulting services to help your needs. We have experienced and high qualified computer system validation consultants who can assess your computer systems compliance assessment or validation against regulatory and industry standards.
ICCON Consulting possesses a strong knowledgeable experts for the qualification of various computer control systems. We are proud of our expertise in this area and our experience covers numerous systems, such as:
- Laboratory Information Management Systems (LIMS)
- Chromatography Data System (CDS)
- Scientific Data Management System (SDMS)
- Supervisory Control and Data Acquisition Systems (SCADA)
- Building Management Systems (BMS)
- Inventory, Troubleshooting, and Calibration Management System
- Quality Management System
- Programmable Logic Controller (PLC)
- Particul Measurement System (PMS)
- Temperature&Humidy Monitoring System
- Commercial Off The Shelf Systems (COTS)
- Excel Spreadsheets