Expert Consulting Services

Consulting is far more than just installing software solutions and moving on. Our experts will be there by your side during the prep work, rollout, training, troubleshooting and beyond.




To assess your critical business challenges and make recommendations to improve overall performance and compliance, we leverage the following:

  • Our deep experience implementing enterprise IT compliance solutions
  • Our knowledge of best practices in the life science industry
  • Our expertise in health authority regulatory requirements

Business Analysis

Our expert consultants can:

  • Assess current business processes and systems
  • Lead and facilitate the development of global user requirements and business processes
  • Configure compliance solutions
  • Develop software validation documentation
  • Develop training material and execute training on compliance IT solutions
  • Provide production support after go-live

Project Management

We combine our project management expertise with our experience in business analysis and software validation to successfully manage the implementation of IT compliance systems—on time and within budget.


Change Control

We help firms optimize their business processes through:

  • Communicating with stakeholders
  • Authoring change controls and technical documentation
  • Analyzing business requirements
  • Mapping resources
  • Driving accountability for deliverables

Business Process Harmonization

Using our proven methodology, we can help you develop global, best-practice business processes with limited site variations.

IT Roadmaps

We can guide you through the selection and deployment of critical IT functionality, using our established methodology.

Validation Services

Our consultants can generate a full range of validation deliverables, including:

  • User requirements specifications
  • Traceability matrices
  • Installation qualifications
  • Operational qualifications or system testing
  • Performance qualifications or user acceptance testing
  • Validation summary reports



We develop and customize training plans, user manuals and job aids to meet your needs, as well as enable positive change.