Welcome to Valicore's Services

Computerized System Validation

• Experts in the following documentation:​

  • IQ​, OQ, PQ

  • URS & FRS

  • Risk Management ​

• Experts in the following computer systems:​

  • Manufacturing Execution Systems (MES)

  • Electronic Document Management Systems (EDMS)

  • Enterprise Resource Planning (ERP) Systems

  • Quality Management Systems (QMS)

  • Clinical Trial Management Systems (CTMS)

  • Regulatory Information Management Systems (RIMS)

  • Data Acquisition Systems (DAS)

  • Statistical Analysis Software

  • Electronic Batch Record Systems (EBRS)

  • Analytical Instrumentation Software (e.g., Chromatography Data Systems)

  • Computerized Maintenance Management Systems (CMMS)

  • Supply Chain Management Systems

  • Electronic Data Capture Systems (EDC)

  • Pharmacovigilance Systems

  • Laboratory Information Management Systems (LIMS)

Quality Assurance

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• Quality System Development

• Compliance Audits

• Document Control

• Supplier Qualification

• Risk Management

• Corrective and Preventive Actions (CAPA)

• Change Control

• Batch Record Review

• Validation Support

• Regulatory Compliance

• Quality Metrics and Reporting

• Inspection Readiness

Project Management

• Waterfall, Hybrid, and Agile Methodologies

• Project Planning and Scope Definition

• Timeline and Resource Management

• Vendor Management and Stakeholder Collaboration

• Risk Identification and Mitigation

• Communication and Stakeholder Management

• Budgeting and Cost Control

• Quality Assurance and Control

• Progress Monitoring and Reporting

• Change Management

• Team Collaboration and Leadership

• Documentation and Knowledge Transfer

Business Administration

• Requirements Gathering

• Admin of IT Systems (ex. Veeva Vault)

• Process Analysis and Improvement

• Data Analysis and Insights

• Regulatory Compliance

• Business Case Development

• User Acceptance Testing (UAT)

• Change Management