CSV  |  Remediation Transition Validation & Compliance Project Management Project

Compliance and Validation Project Management
  • Area: Greater Los Angeles
  • Key Account Manager: Nancy Huang
  • Project Type: CSV

About this Project

OBJECTIVE

Validation and compliance project for the transition of computerized systems from the previous system

SERVICES

This project is a remediation Validation and Compliance Project Management for the transition of computerized systems from the previous system. Responsibilities included/include: Assessing validation and compliance related requirements and deliverables

Nancy Huang

Director of Operations

sales@biotech.com

based on the technical nature of the system transitions (e.g. decommissioning, migrate in place, SDDS) , Identifying and defining the system transition sequence, timeline, resource requirement, responsibilities, required for each system within the scope of the transition, Authored the overall transition compliance plan, Managed the resources, timeline and deliverables identified to complete the compliance and validation deliverable as defined in the compliance plan, Provided deliverable quality review and provide project-related documentation management and organization, Identified compliance, policy and procedural gaps in the procedures and define immediate and long term recommendation and plans, Facilitated meetings with stakeholders and key status meetings. PSC® Provided status reports to indicate system deliverables, dependencies, milestones, responsibilities, due dates and risks.

EQUIPMENT USED

  • Kaye Validator
  • Additional SIM for Kaye 2000
  • iRTD-400 Probe
  • LTR-140 Bath
  • HTR-400 Bath
  • Data Loggers
  • Kaye Feed Thru Device
  • Pressure Transducer
  • CLiMET (laser particle counter)
  • Low Pressure Gas Flowmeter
  • CLiMET (Microbial Sampler)
  • Shortridge Air Data MultiMeter
  • Druck Pressure Testing
  • Gas Flowmeter
  • SVMS Steam Quality
  • Thermocouples
  • Scissor Lift
  • Specialized PPE
  • Specialized Tools

PROJECT SUCCESS

PSC® provided one highly qualified Computerized Systems Validation Project Manager to be onsite to provide Compliance and Validation Project Management Services as outlined in the Scope of Work. This project took around 13 months and was successfully kept within budget.  

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