Computer System Validation (CSV)
Ensure your systems comply with regulatory standards with our Computer System Validation (CSV) services. CSV is essential for data integrity, patient safety, and product quality in regulated environments. Our CSV services include:
➤ Regulatory Compliance :
Adhering to regulations and guidelines such as US FDA 21 CFR Part 11, EU GMP Annexure 11, GAMP5, MHRA, TGA, and WHO.
➤ Validation Deliverables :
Preparation of critical documentation including Project/Validation Plans, Risk Assessments, Test Case Preparation, Execution of IQ (Installation Qualification), OQ (Operational Qualification), UAT (User Acceptance Testing), PQ (Performance Qualification), Traceability Matrices, and Validation Summary Reports.
➤ System Validation :
Validating Laboratory Systems, Production & Packaging Systems, Engineering Utilities, Client-Server Architectures, and Spreadsheets.
➤ Gap Analysis & Risk Mitigation :
Conducting gap analysis to identify risks and providing effective mitigation strategies.
➤ Enterprise Application Validation :
Implementation and validation of enterprise applications like eDMS (electronic Document Management Systems), eQMS (electronic Quality Management Systems), LMS (Learning Management Systems), VLMS (Vendor Learning Management Systems), LIMS (Laboratory Information Management Systems), and CMMS (Calibration Maintenance Management Systems).
Thermal Validation
Validate your temperature-controlled environments and equipment with our Thermal Validation services. This is vital for ensuring that your equipment maintains the required temperature range during use. Our services include:
➤ Temperature Mapping :
Assessing equipment and storage facilities such as warehouses, refrigerators, freezers, incubators, autoclaves, and lyophilizers to ensure they maintain the specified temperature ranges.
➤ Critical Equipment Validation :
Validating critical equipment including Autoclaves, Lyophilizers, Fermenters, Vacuum Ovens, Cryogenic Freezers, and Stability Chambers.
➤ Documentation & Reporting :
Providing comprehensive documentation including Temperature Mapping Studies and Thermal Validation Reports.
➤ Regulatory Compliance :
Compliance with GMP, GLP, and other relevant industry standards for thermal validation.