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VALIDATION SERVICES

Validation Services: Ensuring Performance with Precision

At PACIV, we rigorously document and verify every system to ensure it performs exactly as intended. Our validation solutions are aligned with approved designs and functional requirements, delivering reliable, sustainable results our clients can trust.

PACIV’s Commissioning & Qualification (C&Q) and Computer System Validation (CSV) services ensure a smooth, compliant implementation process. From initial planning and design through the full System Development Lifecycle (SDLC), we ensure systems are properly commissioned, qualified, and maintained in a validated state, supporting long-term reliability and regulatory readiness through to system retirement.

Computer Validation Services Paciv

Commissioning, Qualification & Validation Services

    • Risk-Based SDLC Services: Comprehensive Commissioning & Qualification (C&Q) and Computer System Validation (CSV) services aligned with FDA, ICH Q9, ASTM E2500, and ISPE (GAMP and C&Q) guidelines.
    • Automated Process Systems: Validation of in-process automated filling, assembly, and delivery lines.
    • Packaging Systems: Qualification of systems such as cartoners, palletizers, print/verify units, and more.
    • Facilities and Utilities: Validation of systems SIP/CIP, BMS/CMS, AHUs, Metasys, and NAE controllers.
    • Laboratory Equipment: Qualification of lab instruments; homogenizers, spectrophotometers, balances, freezers, and coolers.
    • Gap and Risk Assessments: Identification and mitigation of compliance and performance risks.
    • Regulatory Remediation Support: Expert consultancy for FDA 483 observations and Warning Letter responses, remediation planning & execution.
    • Vendor Evaluation and Qualification: Assessment and qualification of third-party vendors to ensure compliance and performance standards.
    • Validation Operations & Configuration Management: Services include system administration, configuration control, and security management.
    • Maintaining a Validated State: Support for backup/restore, disaster recovery, business continuity planning, and periodic reviews.
    • Cleaning Validation: Development and execution of cleaning validation protocols to meet regulatory standards.
    • Data Integrity & Migration Services: Verification of data migration, integrity, and retention across systems and platforms.
    Verified Performance Through Documented Compliance
    validation services phases

    PACIV delivers full Commissioning & Qualification (C&Q) and Computer System Validation (CSV) services to ensure smooth, compliant system implementation.

    From concept to retirement, we manage the entire System Development Lifecycle (SDLC) tailored to your policies and aligned with ISPE GAMP™ and C&Q guidelines. Whether launching a new product line or upgrading existing systems, our decades of hands-on expertise ensure your systems remain validated, reliable, and audit-ready.

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