QA CSV | System Implementation & Upgrading

QA CSV | System Implementation & Upgrading

QA CSV | System Implementation & Upgrading

Implementation & Upgrades
  • Area: Greater St. Louis Area
  • Project Type: CSV

About this Project

OBJECTIVE

Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation.

SERVICES

PSC Biotech® is helping our client, a global leader in testing and laboratory services located at St. Louis, with a Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation. PSC™ had to support an aggressive project schedule and a global implementation team to ensured the project milestones were met with no loss to the overall project quality needed in an FDA-regulated environment. PSC™ accomplished this by using an IT-trained QA lead to manage the project from the QA and compliance perspective with one computer system validation resource to review post execution scripts and a Watson LIMS expert to advise and review the business process and standard operating procedures created by the client. This project required full PSC™ review and guidance on the technical details of the project and the entire computer system validation life cycle, including the validation plan, user requirements, testing protocols, and the release of the system with the approval of the final summary report.

Project Success

This project is an ongoing project and underway to completion.

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Calibration Software | CSV | Risk Assessment, Qualification, and Validation  

Calibration Software | CSV | Risk Assessment, Qualification, and Validation  

Calibration Software Risk Assessment, Qualification, and Validation  

Testing of Critical Software Activities

  • Area: Greater Durham Area
  • Project Type: CSV

About this Project

OBJECTIVE

Calibration Software Risk Assessment, Qualification Protocols, and Validation Plan Development. 

SERVICES

PSC Biotech® performed a Risk Assessment of critical calibration software functionalities and developed a Validation Plan. Our consultant developed configuration specifications, performance qualification protocols, and test scripts for specification of testing of critical calibration software activities. They completed gap assessments or vendor installation qualification, operational qualification, user requirements, and traceability matrix documentation forms. PSC® generated risk-based testing of the calibration software system and generated a final validation report which included a summary of protocol tests.

Project Success

The project was successfully finished on time and within budget. The company was very happy with the work completed.

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20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

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CSV  |  Remediation Validation & Compliance Project Management Project

CSV  |  Remediation Validation & Compliance Project Management Project

CSV  |  Remediation Transition Validation & Compliance Project Management Project

Compliance and Validation Project Management
  • Area: Greater Los Angeles
  • 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

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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10 years of required CSV support from our consulting team. We continue to work with this client.

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CSV | CRM & Vault Modules Projects

CSV | CRM & Vault Modules Projects

CSV | CRM & Vault Modules Projects

6 Years of Required CSV Support From PSC®

  • Area: Cross-Regional; California, Ohio, Canada
  • Project Type: CSV
  •  

About this Project

OBJECTIVE

Cross-regional CRM and Vault Module CSV & OQ Test Scripts, IOQ Protocols, and Traceability Matrices Projects

SERVICES

PSC® has provided the client with cross-regional support in California, Ohio, and Canada. These projects have focused on the clients CRM and Vault modules(QMS, eTMF, Quality Docs, PromoMats, EDC). PSC® provided cost-effective support of aggressive software release schedule (every 4 months). The PSC team has ensured no impact on client release dates. Along with CRM & Vault modules, PSC® was responsible for executing and generating OQ Test Scripts, IOQ Protocols, and Traceability Matrices.

PROJECT SUCCESS

PSC® hired 6-8 resources per project to strictly maintain the project schedule, execute the project, track the progress of validation deliverables of the project, and adhere to the project budget for successful completion.

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CA+Ireland Full Spectrum Projects

CA+Ireland Full Spectrum Projects

CSV | Ireland +

California  |  Full Spectrum Projects

10 Years of Required CSV Support From PSC®

  • Area: Novato, CA; Cork, Ireland
  • Project Type: CSV

About this Project

OBJECTIVE

CSV Support Projects

SERVICES

PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS. The PSC® Service Lead manages account (budgets, resources) and provides CSV Subject Matter Expert input. For various CSV projects, PSC® has provided the client with validation plans, risk assessment, HPQC Support, and test script development. Additionally, PSC® has developed installation/operation/performance qualification protocols for the client.

PROJECT SUCCESS

For over 10 years, PSC® has exclusively provided all CSV support for this client. PSC® hired 10-15 local CSV resources per project to strictly maintain the project schedule, execute the project, and adhere to the project budget for successful completion.

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