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This package features 34 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within a Medical Device organization.

This package features 29 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within an organization.

This training package features a comprehensive introduction to the CAPA (Corrective Action and Preventive Action) process.

This template package features a universal Change Management Form Template that provides a method for formally tracking and approving changes in a project which are outside of the approved project charter or project plan.

This template package features a universal Communication Plan Template that provides a method for clearly defining the communication responsibilities, rules, vehicles, and frequency for any project.

This training package features a technical presentation which provides a comprehensive overview of data logging in FDA regulated industries.

This package features a technical presentation which provides an overview of Automated Inline Dilution processes and equipment.

This template package features three universal Kickoff Meeting Agenda Templates that provide the tools to effectively facilitate and manage a 2 hour, 4 hour, or 8 hour long Kickoff Meeting for any project.

This training package features a technical presentation which provides a comprehensive introduction to process water coolers.

This template package features a universal Project Closeout Form Template that provides a method for formally closing out a project, including performing a Lessons Learned, Risk Plan review, and project file archival.

This template package features a universal RACI Diagram Template that provides a method for clearly communicating roles and responsibilities on a team during any project.

This SOP package features an SOP template that provides a step-by-step procedure and test logs for thermal mapping a pharmaceutical refrigerator.

This package features a standard procedure which outlines the approach for managing risk within any project. Three universal templates to support the creation of a plan for managing risks are also provided.

This template package features a universal Stakeholder Analysis Template that can be used to outline those individuals and/or organizations who may impact or be impacted by a project.

This template package features a universal traceability matrix template that provides a ready-to-populate document and spreadsheet to generate a trace matrix for any system validation.

This template package features a comprehensive outline of the information required in a User Requirements Specification for the Biotechnology, Medical Device or Pharmaceutical industries. It includes sections for process overview, design and construction, operational requirements, automation requirements, safety, acceptance and delivery, and documentation. Suggested technical content is also included throughout the template.

This package features a universal Weighted Grid Analysis Tool that provides a method for comparing multiple project options.