2. Custom Software Development.
Develop application software as per need basis for manufacturing companies .
3. Multivariate solutions for PAT
Validation of Computer and software Systems for pharmaceutical ,biotechnology
and medical Devices
- Develop Validation Master Plan
- Provide on-site consulting for computerized system validation for : prospective , retrospective and concurrent.
- Evaluate and develop compliance strategies with 21 CFR Part 11
- Develop System Development Lifecycles (SDLC)
- Qualification of CS. IQ , OQ , PQ
- Develop Validation strategies for : Custom Developed Systems
Configurable Systems (ERP)
OTS Systems (Oracle Clinical)
Widely Used Applications (Excel Templates)
Shop floor Equipment (PLCs)
Building/ Facility Automation and Management Systems (BAS, BMS, FMS)
Electronic Document Management Systems (EDMS)
Laboratory Information Management System (LIMS)
Warehouse and Quality Control Monitoring Systems
Computerized Maintenance Management System (CMMS)
- Training courses : Complete training including :
- Modern computer system and software validation
- Advanced computer system and software validation
- Corporate Network Validation
- LIMS Validation
- Gap Analysis
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