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Welcome to Valicore's Services

Your Trusted Partner in Ensuring Excellence

At ValiCore Consulting, we take pride in delivering comprehensive regulatory compliance, business administration, project management, validation and IT services, that empower organizations to thrive. Our team of experts are dedicated to assisting you in meeting your commitments to business needs or regulatory organizations such as the FDA, EMA, and ICH.

Quality Assurance

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

  • 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

Computerized System Validation
Business Administration
Project Management

Contact Us

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 Valicore Consulting Inc.

Address. 2010 Crow Canyon Pl Suite 225 San Ramon, CA 94583

Tel. 925-209-9895

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