ARCONDIS UPDATE No. 02|2019: The smarter solution

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Projekt handelt – wir empfehlen, die Validierungsanforderungen
immer so früh wie
möglich bei der Projektplanung zu berücksichtigen.
So können die Vorbereitungen parallel
mitlaufen und im Idealfall der eigentliche
Validierungsaufwand verschlankt werden.
Valentino Ducati
English
E_As a result of the ever-tightening regulatory
requirements for supply chain processes
in the pharmaceutical and medical
device industry, unvalidated SAP systems
are deemed GxP-relevant components
increasingly frequently. Installations that
recently required no more than a simple
qualification now prompt clients and authorities
to demand retrospective process
validation.
Generally speaking, the validation of platform
systems always adheres to the same
logical steps: requirements definition, risk
analysis and assessment, testing. But SAP
R/3 or S/4HANA are rarely implemented ‘in
the greenfield’, as most established companies
already have their own ERP system.
A frequent exception:
retrospective validation
Major release upgrades, e.g. from an existing
SAP system to S/4HANA, are considerably
more common. As the commercial
and control unit within an organization, EPR
systems often take on additional tasks over
time, for instance, when SAP ME is rolled
out in the process management. When a
fully implemented system suddenly becomes
GxP-relevant, revalidation becomes
inevitable. This process is called retrospective
validation.
It poses a considerable challenge for quality
control managers: systems that were rolled
out more than a decade ago, long before
they became GxP-relevant, usually lack
installation protocols. In such cases, we recommend
that our clients limit the validation
of the technical aspects, such as IQ and OQ,
to the strictly necessary steps and focus
primarily on PQ (performance qualification).
This means: extensive, comprehensive
usability testing and the validation of associated
business processes ensure that all aspects
of the application function flawlessly.
applies, for instance, to the new functions
of SAP. If this is the case, it is important first
to establish functions groups and evaluate
which modules are both new and GxP-relevant.
Limiting the validation to relevant
processes and functions considerably lowers
the effort involved.
An implicit exception: lean validation
with intelligent clusters
The greatest challenge in validating an ERP
stems from the transaction-based approach
underlying SAP R/3: instead of a classic tree
structure menu, individual functions/modules
can be accessed by entering shortcuts
or ‘transaction codes’. As a result, individual
modules of the system are used by multiple
processes. Both the ordering system and
the invoicing system access contact data,
for example. This situation calls for a smart
validation strategy that covers all GxP-relevant
functions but avoids validating the same
function multiple times.
There is no magic formula for achieving
this, as every company comes with its own
requirements. Nevertheless. we generally
recommend the following approach to limit
your validation effort:
1. List all SAP transactions with a brief
description of the function, e.g. ‘create
entry’
2. Cluster individual transactions in
processes, e.g. ‘material orders’
3. Check which transaction clusters are
actually GxP-relevant
4. Validate the relevant clusters
When clustering transaction groups, it is important
to understand that SAP, unlike other
systems, does not require users to adhere
to every step of every work instruction. The
onus is on you to decide how the business
processes are actually implemented in your
everyday work. We are currently supporting
a customer from the medical device industry
in their SAP validation project. Using workshops,
we were able to determine a shared,
detailed understanding of the individual
processes. Business representatives ought
to be present as early as in the analytical
phase. Based on said understanding, we
used the customer used extensive lists
to arrange the individual transactions into
process-based groups. This allowed us to
condense more than 300 individual transactions
and small groups (i.e. 300 potential
validation documents) to just 16 groups and
documents.
Recommendation: involve the
validation team early on
When switching to SAP S/4HANA, you
should be aware of certain requirements
for cloud platforms in the GxP-relevant field,
such as the clear definition of customer
and supplier responsibility. The new release
also supports the connection of business
processes with mobile applications. Many
of these applications are developed in an
agile environment, and they require an agile
validation approach (cf. page 12). Regardless
of the specific SAP exception in your project,
we recommend taking validation requirements
into account at the earliest possible
stage of your project planning. This allows
you to make preparations in parallel and, ideally,
achieve a considerably leaner validation
process. Valentino Ducati
In many cases, it is sufficient to validate only
some components of an application. This