Comprehensive CSV
Services

◆Validation strategies that comply with requirements

◆Develop validation master plan (VPM, URS)

◆Design configuration and writing of plans
(FS, CS, DQ, FRA...)

◆Execute validation tests and documentation
(IQ, OQ, PQ, RTM)

Standard CSV File
Template

◆Confirm validation plans

◆Provide standard CSV file template

◆Flexible combination of standard validation
extension services

Verification implementation
Guidance

◆Validation Master Plan Guidance

◆Training of Validation Implementation Process

◆Support of Documentation and report

On-site Support During
GMP Inspection

◆Traceability related Q&A prior to GMP Inspection

◆GMP Compliance Support Document
(DSCSA、EU-FMD)

◆On-site support during GMP inspection