Tony.Moorcroft@CQ-Technology.com

+1  860-753-0179

Operation and Maintenance

  • Site change control planning, initiation and closeout -

    Assists in the initiation of site Change Control requests and help drive action items to closure.

    A workflow process used to assess, manage and document the implementation of a change to a GMP operation.

  • Operations/maintenance spare parts selection -

    Assist in spare part identification and selection.

    A workflow process utilizing manufacture documentation, operational/maintenance SOPs and reliability engineering knowledge to identify retained maintenance spares.

  • SAP, Maximo, Blue Mountain, CalMan data acquisition -

    Assists in securing device/component manufacturer data.

    The mechanism by which engineering data is extracted from design and manufacture documentation to populate maintenance and calibration databases.

  • Standard operating procedure development -

    Assists in document development.

    Procedural documents governing workflow processes related to the all aspects of the operational site including but not limited to Operations, Maintenance, Metrology, Safety/Environmental and engineering.

  • Engineering documentation update -

    Assists in documentation updates.

    The mechanism and workflow process associated with the update of the Operational site’s master engineering drawings, P&IDs and documentation.

  • Asset management database update -

    Assists in database updates.

    The mechanism and workflow process associated with the update of the Operational site’s financial asset database.

  • Capital Project Delivery Program -

    Assists in program development, site rollout and/or global implementation.

    Governing policies, procedures, best practices and workflows by which organizations or operational sites deliver capital projects.

  • Commissioning and Qualification Program -

    Assists in program development, site rollout and/or global implementation.

    Governing, policies, procedures, best practices and workflows by which organizations or operational sites deliver equipment, systems and processes that are fit for their intended purpose and comply with cGMPs and regulatory requirements.

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Tony Moorcroft

avatar Tony brings to the table a blended strategy based on ASTM E 2500-07 (Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) and the ISPE Commissioning and Qualification Baseline Guide - with a career exclusive in ... [Read More...]