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A valid SAP system? What's to come now?

A valid SAP system? What's to come now?
A valid SAP system? What's to come now?

What happens after the «big bang»?
After almost endless efforts, many weekends of working and long project evenings the go-live was finally successful – the opening balance was checked and found to be correct paving the way for releasing the system for booking. The euphoria of the go-live party has already faded and the daily routine has taken over, or hasn’t it? What exactly happens after all the validation and project work that was accomplished in the implementation phase? And what are the critical points to be considered after a SAP validation?

The scenario during go-live
Many CEOs, system owners and users think that the topic of validation is closed with the creation of the validation report after the last great efforts in the cut-over-phase were made and the go-live was performed – that is to say when the project ended. The last phase of the new implementation or an upgrade/migration project requires the project team to solve many parallel tasks:
•    Finalizing the tests and creating the respective reports
•    Fixing bugs and performing last minute changes
•    Executing tests a second time and releasing the system at the last minute
•    Creating and conducting the user trainings
•    Cleansing the data for the last time and providing it for the final upload
•    Preparing the closing activities in the legacy system
•    Preparing the inventory and the initial stock data transfer into the new system
•    Transferring open items (financial accounting data, produc- tion and purchase orders, open invoices …)
•    Taking care of daily business despite everything else
•    and so on …
Moreover, there is the validation lead, who annoyed the key-users and consultants because he kept on interfering and slowing them down by correcting and questioning them over the whole duration of the project. And of course he never got tired of reminding everyone of the validation plan and the importance of a systematic and controlled system creation and implementation, to obtain or keep the GMP-compliance, audit and inspection stability according EU-GMP Annex 11,15 or 21 CFR Part 11,211 for the company under these regulations.

In due time for the go-live, the – at least temporary – suitability of the system for operations was acknowledged by the steering board because of the functional (OQ) and integration / process (UAT or PQ) test results. Moreover, the decision was documented in version 1 of the validation report (VR1 – go-live report) and, for the time being, the system was released under observation. Open issues, which put neither the operation of the system nor the safety of the product at risk, are added to the VR1 follow-up activities list. It may even be the case, that a ’less important’ module lags behind and will go live a couple of weeks later.

… and right after the go-live?
In the first days and weeks after the go-live bug-fixing is the most urgent matter:

  1. Incorrect master data and data migration errors are usually the most frequent source of trouble.
  2. Missing access rights for single users and user mistakes affect daily business.
  3. Because the testing had to be executed in a special environ- ment it was not possible to use all printers, which is why stuck print jobs can be encountered quite often.
  4. And of course it is in this phase when mismatches between the implemented and tested processes and the real work-flows or special business cases, which could not be detected in the URS/FS or the testing / validation phase as system errors, become apparent. Thus, the first change requests become necessary and the processes must be optimized or extended.

Mistakes belonging to the categories 1– 3 lead users into a situation that they are not able to put everything they have learned into practice or to execute processes correctly. Problems of the 4th category make working with the SAP system feel uncomfortable or at least very unfamiliar. To counter that, there is usually an agreement with the consultants and key-users upon a hyper-care phase which lasts between 4 and 6 weeks and which allows solving problems quickly using the internal hotline. The most challenging part here is to interrupt the workflow as little as possible while creating – from a GMP point-of-view – a good interaction between user and system configuration.


The challenges of the immediate post-go-live phase:
From a validation point-of-view the hasty adaptations that were necessary in the first days after go-live are a complex issue:

  1. In this phase there are typically a number of predefined follow-up activities for the finalization of the lifecycle documents and the final validation report (VR2) like e.g.: transport order logs, data migration logs and the completion of test protocols, re-tests, the traceability matrix, completion of reports and change requests from the project.
  2. If problems are solved ad-hoc via the hyper-care hotline, parts of the validation documentation may become invalid and the overall system validity may be compromised.
  3. It is quite understandable that daily business requires immediate solutions. Still, one must keep in mind that the traceability and the follow-up documentation, of course in accordance with the validation plan and the defined change procedure, must be guaranteed at all times.
  4. None of the system administration processes – especially not the change management procedure – are well attuned and the necessary SOPs have not become routine yet, which is why the transition phase is extremely critical.


Nevertheless, in a validated system environment it is fundametal to implement and stabilize those error handling / optimization processes while not neglecting to valuate and document those activities. The basis for the operating phase has to be established during the ongoing project already (see GAMP5©).

The most critical factors for the transition towards standard operations
To ensure that the system is running properly in the middle-/ long-term and that the validation efforts are not put in danger, there are a number of success factors to be considered in the project phase and the hyper-care phase:

  1. Achieving a shared understanding of the validation’s significance and the importance of following the rules from the very beginning
  2. All project participants should develop a «certain» routine in the validation activities, meaning that those aspects will become relevant to them and should become daily business
  3. Establishment and enforcement of a well-defined change management process as early as possible in the project phase to ensure up-to-date lifecycle documents, a structured progress of the project and a smooth transition to standard operations
  4. Implementation of the traceability matrix covering everything from the user requirements to the release test
  5. Realization of the risk-based approach and test / release procedures that are permanently subject to the change management process
  6. Raising the awareness of everyone involved in the operation of the system for GMP requirements and for the significance of risk assessments
  7. Precise definition of the responsibilities and accountabilities of process owner, system owner, system operator, validation lead and the companies Q-unit
  8. Definition of a procedure that clearly outlines how emergency changes are handled in the immediate post-go-live phase
  9. Setting up the user and access rights management in SAP Basis and raising the necessary awareness of the process owner
  10. Establishment of a leveled support model that covers everything from the user to the 3rd level support
  11. Technical aspects such as backups, recovery procedures, system availability, capacity management and the user helpdesk need their time till they work correctly. Nevertheless, those aspects should be considered and organized during the project phase including qualifying the infrastructure in accordance with EU-GMP Annex 11 or Part 11
  12. Appointment of a due date for the revision of the final report about 6 month and a due date for the first periodic review about 12 months after the go-live


«Keeping SAP in a valid state » after the end of the project- and transition phase is a permanent process, which extends over the whole lifecycle of the system and which is challenging for those who are responsible. We are eager to support you in implementing the necessary processes in your company by sharing the knowledge we have acquired throughout the years.

 

Dr. Thomas Karlewski|Management Consultant| Joachim Steinmaier|IS/CSV-Consultant|Chemgineering|The Business Designers

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