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Computer System Validation
For Life Science Industries, your systems may be subject to regulations and limitations set out by GAMP5, ICH, TGA, MEDSAFE, EMEA regulations, and 21 CFR Part 11 regulations to make sure electronic records and electronic signature are controlled. We have a risk-based approach to computer system validation ensuring the right amount of testing and documentation is undertaken. It reduces considerable time and money while performing Computer System Validation. Our extensive experience in the Life Science Industries can be leveraged to make your next implementation in line with compliance requirements.
Qforce’s Computer System Validation Services include but are not limited to:
- Manufacturing Execution Systems (MES)
- Laboratory Instrumentation and Software like HPLC, GC, Spectrophotometer
- Laboratory Information Management System (LIMS)
- Electronic Document Management Systems (EDMS) – Documentum
- Manufacturing Equipment’s( PLC/SCADA based) like Bio-reactors, Fermenter, Autoclaves, RMG
- Enterprise Applications like SAP, Trackwise, Learning Management System, etc.