We provide Computer System Validation, Equipment Validation, Laboratory Validation Services

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Computer System Validation
21 CFR part 11


Project Planning
Computer System and Software Validation
Risk Assessment and Analysis for 21 CFR part 11 compliance
Computer System Remediation
Software Development
User Acceptance Testing
Factory Acceptance Testing
Developing URS, FRS, and SRS
Installation Qualification (IQ)Plan
Operational Qualification (OQ) Plan
Performance Qualification (PQ) Plan
Validation Protocols IQ, OQ, PQ
Validation Protocol Execution
Validation Reports
Traceability Matrix
Writing SOPs
System Audit and Review Software Development Services

Site Validation,
Laboratory and Manufacturing Equipment Validation

Master Validation Plan
Risk Analysis
Risk Assessment
Installation Qualification, IQ
Operational Qualification, OQ
Performance Qualification, PQ
Design Qualification, DQ

Laboratory Instrument Maintenance Service:

Laboratory Equipment Maintenance
HPLC Maintenance Service
GC Maintenance Service
Mass Spectrometer Maintenance Service
Incubators Maintenance Service
Refrigerator Temperature Mapping
Incubators Temperature Mapping
Incubators Humidity Mapping
Refrigerator Maintenance Service
UV Spectrometers Maintenance Service
Manufacturing Equipment Maintenance Service

Laboratory Instrument and Manufacturing Equipment Validation and Qualification Service:

Installation Qualification
Operational Qualification
Performance Qualification
Design Qualification
Temperature Mapping for Refrigerators and Incubators

Please contact us so we can discuss with you our capabilities and our cost effective prices.