Software Validation Risk Management Software Testing Business Analyses Compliance Management Auditing

With this approach, which has proven itself in practice, you can achieve the following with us

  • design stepwise your requirements on all abstraction levels
  • align to regulatory, functional and quality requirements
  • verify the requirements by deriving examples from test cases and create scenarios
  • ensure traceability of all requirements through the entire life cycle
  • deliver high quality requirements, which are measurable and verifiable 

 

The major pre-requisite to get the right system is the understanding, design and modeling of the business processes and the requirements.

We systematically break down the requirements into hierarchical abstraction levels. The requirements and their related technology are depicted in increasing detail at each level (see diagram).

Abstraction levels

System and Strategy Layer

Goals, WHY?

  1. e.g. 21CFR Part11 compliance
  2. Globally standardized analytical processes
  3. Paperless released measurement results
Feature Layer

Capabilities, WHAT?

  1. e.g. Audit Trail
  2. Workflow
  3. Multi-Language support
Function Layer

Functionality, WHAT?

  1. e.g. Change logging and history
  2. Electronic signature, deputy rules
  3. Context related language change
Implementation Layer

Components, HOW?

  1. e.g. Password entry for changes
  2. Oracle Database
  3. Icons