Real holistic Gap assessment

GAP assessment/analysis 21 CFR part 4 including EU/US cGMP

Important to start as soon as possible with a detailed GAP assessement. This will be documented input for the leadership team for deciding on improvement activities.

Gap assessement best to follow our 2 day first information exchange visit:

• Why and how to make a (site) process map
• What a structured process audit means
• What is expected and possible from risk management
• How we always use the original requirements text…

We know that your staff precisely knows if a requirement has been fullfilled…… when confronted with the text of the requirement.

Let us use that powerfull capacity to complete the gap assement in record time!

We will visualize and present the results in the management team or other interested group.

Contact us for more information.

GAP assessment/analysis brochure

How "ready" is the individual requirement?

We have learned to use a simple expression for the status of a requirement/situation:

1. Green: Good to go, ready
2. Orange: Depending on circumstances this requirement can result in a “finding” or Non-Conformity. Improve asap.
3. Red: Has to change asap.

Like a traffic light. Benefit: Everybody understands it, without discussion.

Below see a sample presentation of a “GAP Map”