Our Projects
Computerized Systems Assessment
(21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5)
INDEPTH REVIEW
Computer System ValidationData Protection and Security ControlsSoftware ConfigurationsAudit TrailsData Backup, Archival and RestorationREMEDIATION PLAN
Action plan for each findingProcedural ControlsInterim Control to ensure Data securityLong-Term and Short-term actionsData Accuracy and Completeness Assessment
Lifecycle Management
Design a companywide Computerized system policies and proceduresQualification and Operational Requirements (Deviations, Changes and Updates etc.)REMEDIATION PLAN
Support in achieving sustainable compliance in area of GxP IT (network system and stand alone systems)Advise on automation systems like MES,DAS etcMentorship in forensic internal auditing of computerized systems