Experienced support for regulatory compliance

Our Computer System Validation Service can help you to meet your regulatory requirements. We work closely with our clients and help them to get into production faster, at the same time allowing them to control validation costs and manage their compliance risk.

Our Services

Computer System Validation

• Analytical Instruments – HPLC, GC…
• Enterprise Applications like SAP, LIMS …
• PLC/SCADA …
• Other Software’s, Patient Care Application, ARGUS…

Audits & Assessments

• cGMP Audits and Assessment as per USFDA/EU/MHRA/Geneva WHO
• Third Party IT Vendor Audits
• Regulatory Assessments (21 CFR Part 11…)
• GAMP5 Assessments
• IT Maturity Assessment
• Virtual Vendor Audits

Trainings

• Computer System Validation & GAMP5
• Data Integrity / Data Privacy / Data Security
• cGMP / GLP / GCP / GDP
• GDPR
• Qualification and Validation Concepts in Life Science Sector

Compliance during IT Application Support

• Managing compliance of Incident/Problem/Service/Change Request Tickets
• FDA /Internal IT Audit Support
• CSV Document Review and Support
• Compliance Dashboard

Documentation

• IT Documentation providing support on preparing policy , procedures and formats for IT QMS
• SOPs
• Checklist and Templates

cGMP Services

• Plant Design and Project Execution
• QC Laboratory – Design and Consultation
• Equipment Qualification Services including virtual FAT