Categories: Founder's Blog


Sam Bayer


When Agile meets FDA validation

A few weeks ago we launched yet another successful SAP Integrated B2B eCommerce website project.  This project was uniquely challenging in that before we could go into production, the system had to be validated to adhere to the US Federal Drug Administration’s (FDA) 21 CFR Part 11 Regulations for electronic records and signatures.  Culturally, FDA validation is about as far away from our Agile DNA as you can get, so we had a lot to learn and adjust to.

I believe that three of the more critical success factors were to:

  1. Anticipate as many of the SAP changes that we would require as early as possible in the project.
  2. Run the first 90 days of the project with our normal Agile approach until we could get a stable “requirements verified by real customers” version of the application and THEN run it through the FDA validation processes.
  3. Stay flexible and open minded.

Overall, this was a great client project team to work with.  I think part of that was due to the fact that this particular division of a 100+ year old Consumer Brand company has been desperate to implement a B2B portal for over 7 years.  They simply couldn’t find a solution that would work for them…until they met us :-).  Seven years of anticipation really made them appreciative of how they were about to change their business.

After the project went live, the client sponsored a Project Retrospective and solicited input from our Implementation Consultant, Ray Mannion.  Ray put together such a thoughtful analysis of why he thought this project went as smoothly as it did, that I felt as if I had to share it.  So here is the email that Ray sent to the Client Project Manager:



Thanks for the offer to provide feedback.  Below are some comments I made after we went live and I provided a “Retrospective” to my team at b2b2dot0.

Keys to the success of this project:

·        The “XXX” team all knew the validation process backwards and forwards.  All documents were provided to us, reviewed quickly, and requests made clearly.  Their expertise is an asset.

·        Kevin and Lois did an excellent job testing.  They provided quick turnaround on open questions/issues.  They sought feedback approval from “XXX” management and returned with decisions quickly and confidently.

·        Kevin and Lois know their business in great detail, knew all the important scenarios to test.  Their expertise is an asset

·        Having Jane dedicated to project management kept open issues visible and allowed me to focus on the work to be done rather than being a PM.  Her write-ups/emails kept all parties informed and highlighted open issues.  Her foresight to the process of validation allowed us to start on day 1 and finish on time.

·        Support from the SAP tech team was quick, knowledgeable and helpful.  Changes to user exits were made quickly despite the very challenging nature of them and possible collisions with other projects in midstream.  (Lyn/Joe)

·        “XXX” committed to keeping the application enhancements to a minimum allowing us to have fewer items with better quality and a project completed on time

·        “XXX” team aggressively pursued focus groups, building confidence prior to go-live.



·        Desktop VPN connection – took a very long time to get correct, automatically ends every 90 days without warning.  Caused delays in implementation.  Leaves “XXX” vulnerable in the event of production issues or production support requests.

·        Server VPN and email setup took a very long time to complete – 3rd party didn’t seem to understand requirements or didn’t seem responsive/knowledgeable

·        The CPD demo exposed issues with how code in SAP userexit_save_document_prepare is written.  Created function modules as demonstration of how to handle going forward.  We recommended to SAP tech team that going forward, changes to this user exit be considered for external function module calls so that we can apply the same logic during simulation.  The case in point here is the various blocks assigned for CPD and the need to relay that information to the user.

·        This was our first client where it was possible to have a ship-to determine the payer.  (This didn’t require much effort on our part, but was noteworthy to us.)

We would ask that “XXX” consider the two items bolded above as points to address going forward.

 All in all, b2b2dot0 agreed this was probably our smoothest implementation and a pleasure to work on.


Ray Mannion

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