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Specialized services
are offered in the following key areas:
Computer
System Validation (including DCS systems)
Process Equipment Qualification (IQ/OQ/PQ)
Process and Cleaning Validation
Batch Record Design and Preparation
Process Capability Analysis
Risk Assessment
Design and Implementation of:
Change Control Systems
Deviation Systems
Computer System Validation strategies
21 CFR Part 11 compliance strategies including Gap Analysis
Technology Transfer strategies
Investigations associated with process deviations
Facilities and Utilities Qualification
Process Support
Project Management
We also provide specialized training in key areas such as ICH Q7A
GMP Guidelines, GAMP
Guidelines, 21 CFR Part 11 (Electronic Records & Electronic
Signatures), Computer
Validation, and others. |