Implementation Strategy for SOLABS QM

We recommend to spread out a total e-QMS implementation in several waves.

The choice of exactly what will be implemented at first depends highly on targeted areas of improvements, something specific to each client. SOLABS can assist you in identifying the appropriate implementation strategy based on your expected ROI and operational and/or compliance improvement guidelines.

The data we have compiled over the years allows us to provide future clients with guidance on the typical efforts required to move to an electronic Quality Management System. The diagram below can assist you in establishing your priorities. However you need to consider this could be highly different from one organization to another.

Notes on chart provided below:

  • The Vertical Axis (%) represents the % of a FTE (Full-Time Equivalent) that would be required to complete a project for each item presented on the horizontal axis. This considers that this FTE (or % of) would be dedicated to one specific area only (see horizontal axis) for a period of 2-4 months, depending on the complexity of the work.
  • The list of document types and quality processes is non-exhaustive.


As an example, a typical implementation scenario could be constructed in the following way:

Phase 1

  • Document Control: SOPs and Forms
  • Quality Processes: Complaints and CAPA

Phase 2

  • Additional Quality Processes: Deviations and Investigations
  • Document Control: Methods and Specifications

Phase 3

  • Additional Quality Processes: Change Control
  • Include GxP training record management