Quality Compliance Architects

Quality Compliance Architects (QCA) Your trusted partner in quality, regulatory and safety compliance. QCA is a privately owned company formed in July 2018. It provides innovative consulting, training and service solutions to ensure your compliance ensuring effective operation. The solutions it provides at present are as below: 1. Quality Compliance - We provide Implementation and Certification assistance for - * Design, Development and Implementation of QMS * Good Distribution Practices * Good Clinical Practices * ISO 9001: 2015 QMS * ISO 45001:2018 (OHSAS) * ISO 1345 Medical Device - Quality Management System * ISO 14971 Medical Device Risk Management System 2. Training - We provide training on - - Awareness Training * QMS * GDP (WHO, EU, FDA, PICs) * GSP (WHO) * GCP * ISO 9001:2015 * ISO 45001:2018 * ISO 1345 * ISO 14971 * Adverse Event / Pharmacovigilance Management - Auditing * Internal Quality Audit * Internal OHSAS Audit * Self Inspection * Handling of Audit - Quality Tools / Skills * CAPA Management * Effective RCA (Root Cause Analysis) * Why Why / 5 Whys * 5s * 4M / 4P * Incident Management * Deviation Management 3. Validation: We do validation for you for - - Warehouse - Cold Room - Bio-refrigerator - Passive Packaging System - Temperature controlled delivery van - Entire Cold Chain Mapping - Temperature Mapping 4. Documentation: We do documentation for you on - - QMS Manual - GDP Manual - Site Master file /Site directory - Protocol - Master Procedure / Standard operation Procedure / Work Instruction / Policy / Form - Flowchart / Business process mapping and process interaction 5. Audit Management - We manage your quality and safety audits as like - - Audit Planning - Checklist Preparation - Internal Quality Audit - Internal OHSAS Audit - Supplier / Vendor Audit - Self-Inspection 6. Other Solutions: Other solutions we serve you - Quality and Safety GAP analysis - Quality Risk Management