ValSquare Consultancy Services Pvt Ltd is an independent company founded by a group of professionals providing Computer System Validation & IT Regulatory Compliance services to pharmaceutical, IT industry, Clinical, Healthcare and medical device companies. We help companies define their requirements and by providing technical support & services to meet current regulatory standards. We are specialized in Computer System Validation, Data Integrity, GxP Compliance, GAMP5, Risk based approach validation and Regulatory Compliance Services for IT and Non - IT related areas primarily focus on pharmaceuticals, Life Sciences, Health Care, Clinical and medical device companies. About ValSquare Consultancy Services Pvt Ltd: We are Indian based consulting company providing advanced technical computer system validation services to pharmaceutical / healthcare, medical device and biotech companies as per client requirements meeting current regulatory standards. We are specialized in providing services incudes wide range of services includes but not limited to: - Automated manufacturing equipment - Analytical laboratory Systems (LIMS, CDS, SDMS, Standalone Systems) - Process control systems (DCS, DAS) - Process Analytical Systems - Manufacturing Execution Systems - Enterprise Resource Planning Systems - Clinical Trials Data Management Systems - Vigilance Systems and Document Management Systems. - Implementation of Computerized System Life Cycle with 21 CFR part 11 Compliance and EU Annex 11 Compliance. - Data Integrity and Regulatory Gap Analysis for Computerized Systems. - Remediation for Computerized Systems. - Periodic Review of Computerized Systems - Decommission of Computerized Systems - Computerized System Audits - Implementation of IT Policies and SOP - Change control and Deviations management - Qualification of Equipment - Spreadsheet Validation. - Infrastructure Qualification - Creation of CSV Procedures and Templates
