Tech Qualitas is a provider of cost-effective compliance services in the area of regulatory compliance, Computer System Validation and QA Services to Pharmaceuticals, CROs, Biotech’s, Medical Device Companies, Academic Institutions and Government Institutions. We are targeting global customers to benefit our services and solution. Unmatched Quality with Absolute Ease is the primary goal of Tech Qualitas. SERVICES With decades of industrial experience, our experts specialize in Data Integrity Compliance (US FDA, EU, Health Canada, ICH, ISO, TGA, and other regulatory bodies) and provide services in the area of: • Computerized System Validation Planning & Execution (as per ISPE GAMP5) • Spreadsheet Control and Validation • Risk-based approach & Project Management to computerized system validation and compliance with Electronic Records/ Electronic Signatures(ER/ES) regulations as per requirements of FDA and other regulatory authorities (e.g., EMEA, MHRA, MHLW) • Audits (CSV Audits, Infrastructure and Cloud Compliance Audits, Site Audits (Inspection Ready Assessments, Pre-Approval Inspections) etc.) • Training on CSV and 21 CFR Part11 • Software Development for regulated and non-regulated industry QMS SOLUTION Our Quality Management Solution provides end-to-end management of QA services with different customized integrated and individual modules available as per customer business processes in line with compliance: • Document and Content Management Solution • Change Control Management • User Access Management • Training and Learning Management Solution • Deviation and CAPA Management Computerized Systems Validation Experience of: • SAP Validation • Argus Validation • ARISg Validation • Medical Information Systems • Be-spoke Systems Validation • Oracle Life Sciences Applications • Electronic Submissions System • Quality Management Systems • Manufacturing and Engineering systems (PLC, SCADA, DCS) and Lab systems (HPLC, GC, FTIR, UV, LIMS etc.)
