iPharmatec Solutions

iPharmatec Solutions (IPTS) is a fast-growing international consultancy offering cGMP compliance, risk based commissioning, qualification and validation (CQV), computer system validation and engineering consulting services to pharmaceutical, bio-pharmaceutical and medical device industries. We provide our clients with a competitive advantage by helping them build, commission and operate manufacturing facilities that comply with International cGMP regulations. Services at a glance: Project Commissioning, Qualification and Validation (CQV) Execution and Management COMPUTER SYSTEM VALIDATION: PLC, HMI, SCADA, Automation System, LIMS, ERP, MES, SAP Validation Field Execution (21CFR part 11, Annex 11, GAMP5) TEMPERATURE MAPPING: Warehouse, Autoclaves, Sterilizers, Dry Heat Sterilizer, Ovens, Incubators, Cold rooms Temperature Mapping Cleanroon and HVAC Qualification ISOLATOR | CONTAINMENT SYSTEM VALIDATION - End to End implementation of Risk based Validation / Qualification System - Facility Risk Assessment {FMEA, HAZOP, HACCP, FTA etc.} - Risk-based Cleaning, Process Validation - Validation Protocols / Reports (URS, EDS, RA, DQ, FAT, SAT, IQ, OQ, PQ) - Suppliers Audits GMP COMPLIANCE SERVICES: - System based GMP Audit -> Gap Analysis -> Recommendations -> Implementation with respect to facility, utilities, process equipment, lab instruments, computer systems and quality management system FACILITY CONCEPT DESIGNS, BASIC AND DETAILED ENGINEERING SERVICES - Facility cGMP Design Gap Analysis - Facility revamp and Modernization MEDICAL DEVICES REGULATORY SUBMISSION SERVICES - Medical device complete technical documentation including Software File (IEC 62304), Risk Management File (ISO 14971), Usability File (IEC 62366-1), Safety and Essential Performance File (IEC 60601-1) etc. GMP TRAININGS SERVICES - GMP e-Modules, GMP Books Contact us: +91 9599579585 info@ipharmatecsolutions.com ipharmatecsolutions@gmail.com