Are your systems compliant and audit ready?
We are here to help.
We provide holistic computer system validation, gap analysis, remediation and training services
We provide holistic computer system validation, gap analysis, remediation and training services
Computer Systems Validation for Manufacturing and Laboratory Instruments – PLC, SCADA, BMS, MES, LIMS, ERP, EBMR-EBPR, DMS-LMS-QMS.
Data Integrity Audit and GAP Analysis for 21 CFR Part 11 Compliance and Annex 11 Compliance, Third Party Vendor Audit, FAT/SAT for Equipment and GxP Audit.
Remediation for CSV - DATA Integrity related issues. Closing of GAPS and reply to FDA for 483 – Warning letter and handholding till we clear the audit.
Compliance Training on Why Validation? Role of FDA, 21 CFR part 11 Compliance, Annex- 11, ALCOA+, GAMP5, Risk Assessment, CSV Deliverables, Data Integrity, Learning from recent and old 483 Warning letters.