Computerized System Validation

• IT compliance assessment

• Validation master plan

• IT inventory

• Impact & risk assessment

• Clinical and factory data integrity and authenticity assessment

• User requirement specifications

• Validation protocals (IQ/OQ/PQ)

• Infrastructure qualification

• IT project management

• Process Mapping

• Suppliers auditing & selection

• 21 CFR part 11 & EU Annex 11 compliance