Training and Documentation Projects
Our support doesn't end when strategies, process maps, process documentation, and systems definitions are completed. We support our clients through to the point where the implemented strategies, processes, and systems demonstrate their value to the business. Process and systems documentation, whether paper or on-line, and training programs are a vital part of successful business change.
We have developed and implemented training curricula and materials for:
  • Quality assurance programs

  • Process based training program for implementation of global data management system

  • Train-The-Trainer program for audit procedures

  • Audit Procedures

  • Process modeling techniques and application

  • CAD/CAM systems

We have developed online and paper documentation to support the implementation of:

  • Data standards systems

  • Standard Operating Procedures and Working Practices for regulated processes such as:

    • Distributed Document Authoring Processes

    • Quality Management and Assurance Processes

    • Audit Procedures and Standards in FDA regulated environment

    • Software design, development, and validation processes

    • Trial Master File Management

    • Document Management and Retention 

  • Integrated process and systems user manuals

  • Process documentation to support training and implementation of new processes

We have managed documentation of systems development projects of regulated systems (FDA/21 CFR-11)