xxxxxxxxxxxx is pleased to offer the following services:

  • Computer System Validation  |  Equipment Validation
    Facility Validation  |  Cleaning Validation  |  Part 11 Compliance
    Procedure and Policy Development  |  Auditing  |  GxP Compliance
    HIPAA Compliance  |  Training

    Computer System Validation
    Laboratory Information Management System (LIMS) validation and design,
    Custom database and spreadsheet development and validation,
    HPLC, GC, and CE equipment validation, including configuration and validation of networked data systems,
    Preparation of validation master plans,
    Development of requirement specifications, design documentation, traceability matrices,and other GAMP documentation,

    …and more.

    Manufacturing Equipment Validation
    Process control system configuration and validation,

    Automated manufacturing equipment validation,

    Test equipment configuration and validation.

    21 CFR Part 11 Compliance
    Compliance assessment of laboratory, manufacturing, and support systems, with consideration given to FDA’s 2003 Scope and Application document,

    Configuration, remediation, and validation of deficient systems.

    Procedure and Policy Development
    Preparation, review, and revision of corporate quality policies and validation policies,

    Preparation of procedures for the operation and administration of computerized systems,

    Development of change control policies and procedures,

    Development of SOPs for operation of laboratory equipment and manufacturing equipment.

    Auditing and related GxP compliance services

    Please contact us for a quotation on these services

Serving the Regulated Medical Industries