ARCONDIS UPDATE No. 02|2019: The smarter solution

13
Klassisches V-Modell /
Classic V-Model
Agile Validierung /
Agile Validation
Validation
Plan (VP)
Validation
Report (VR)
URS
URS
URS
User Requirement
Specification
(URS)
Functional
Specification
(FS)
Design
Specification
(DS)
Unit Testing
User Acceptance
Testing
Functional
Testing
VP
FS
DS
FS
DS
FS
DS
Testing
VR
Release
Realization
1
2 3 4 Sprint
soll. In so einem Fall bestehe ich auf einer
sehr engen Zusammenarbeit der jeweiligen
Projektleiter, damit die Milestones der Projekte
zusammenpassen und zum richtigen
Zeitpunkt die notwendigen Anforderungen
für die Entwicklung zur Verfügung stehen.
Vielen Dank für den Einblick zum Vorgehen
und damit zusammenhängende
Besonderheiten!
English
E_Patrick Zahnow manages the validation
and qualification team of ARCONDIS consisting
of seven members. He is an expert
in computerized system validation (CSV)
and supervises many compliance and
quality management projects as project
manager and validation lead. Around 20
years of experience in the pharmaceutical
industry and ten years in the medical
device industry have helped him become
an experienced validation professional in
the life sciences industry.
In his interview with UPDATE, Zahnow told
us about his experiences with validation
projects and gave us some insights in the
special challenges inherent to agile environments.
Mr Zahnow, in what cases are agile CSV
frameworks useful?
Their classic use is the development of
mobile applications in regulated environments.
But agile software development is
increasingly common in the field of business
applications for desktop users. It keeps the
design process flexible and allows developers
to focus on high-priority functions. In
Scrum, for instance, functional components
of an application are completed in individual
iterations or ‘sprints’. To meet all quality and
compliance requirements in an agile development
environment, I recommend using an
agile validation approach. This is also called
an agile CSV framework. It facilitates collaboration
between business, i.e. the specialist
department, and the quality managers,
increases flexibility and accelerates release
cycles.
When it comes to regulatory requirements,
it does not matter whether you choose a
traditional waterfall (V) model or go for an
agile approach instead. Either way is fine. In
the latter case, however, you must be very
clear on which documents are meant to be
released and at what stage, i.e. in which
sprint.
What does a typical agile framework
look like?
Despite what you may expect, agile validation
does not mean carrying out a miniature
V model in every sprint. It is enough to
validate after a few sprints. In my experience,
it works well to have one validation
sprint after three development sprints. That
is what we are currently doing with a client
from the medical device industry, for whom
we are launching a mobile application that
enters customer feedback into the central
complaint management system.
In practice, all documents from the classic V
model – user requirements, functional specifications,
design specifications etc. – are
initially established in the first sprint. During
each subsequent sprint, new functions are
added to these documents. The actual release
and “official” testing take place during
the formal validation sprint. Essentially, we
take care of the left side of the V model
during the development sprints, and the validation
sprints correspond to the right side.
What special challenges does this entail?
The actual validation is similar to the
standard approach, but the agile environment
has some pitfalls. Getting the quality
department on board before the start of the
project is crucial. Unlike the waterfall model,
the agile approach only gives us two to three
weeks to approve all documents. If we fail to
meet that deadline, the entire development
is delayed by a complete sprint. This means
that the approval process must be flawless.
On top of the commitment of everyone
responsible, a solid document management
system is important.
But the main challenge for any validation
lead is a situation in which the developers
use an agile Scrum approach, while the
project managers stick to the waterfall
method. That’s what is happening in one
of our current projects: we are supporting
a manufacturer of laboratory products in
their optimization of a system. Due to strict
instructions of our client, we are using the
waterfall method, while an associated CRM
is being developed in parallel and will have to
be validated. In such cases, I insist that the
project managers work very closely together.
This ensures that the project milestones
are compatible with each other and that the
necessary requirements for the development
are available at the right time.
Thank you for your insight into the process
and its special characteristics!