Why is Software Validation so overwhelming
Anyone who recently experienced the introduction of a validated software system knows that this can be a very hard, challenging and time-consuming task! Non-validated software development on its own is a challenge these days, but if it has to be validated, you better think twice on whether the old system will last you for a few more years. Further, if there is an additional need or wish to implement the project in an agile manner, either because the company strategy dictates more agility, or simply because the external supplier consistently works according to Scrum. Thus, the worry lines of many project participants become real pits to fall into and create a wall of inner rejection and skepticism, as it seems overwhelming.
wega offers Free webinar
In short: different systems and mindsets collide, which are not compatible with one another under traditional aspects. On the one hand, there are the software or product development teams and on the other hand, there is validation and quality assurance of these particular products.
We at wega Informatik AG have always been committed to our mission “Bridging Business and IT”. It is exactly this domain of conflict, which drives us and adds value to our clients. The combination of agile expertise and many years of validation experience enables us to resolve the above mentioned seemingly unsolvable contradictions and to develop suitable individual solutions.
In our free webinar “Agile Validation in GxP” projects, we will demonstrate a few possible approaches to this challenge. There is no “One-Size-Fits-All” solution for this problem and the establishment of agile methods – especially in historical non-agile environments – can be a lengthy process, but it pays off in the end. Just drop a mail to: email@example.com in case you and your colleagues are interested and we will get back to you to schedule your webinar.
Due to COVID-19 situation forcing the cancellation of the Paperless Lab Academy Congress® this year, we decided to offer the workshop we planned to deliver as a free individual webinar for interested customers, because we are convinced that agile validation is possible.
The right approach and an optimal project setup can save a lot of time and money. In a fictitious dialogue between a representative of the consistently agile (non-validated) world as well as a validation expert with many years of experience, typical problems get presented in an entertaining way. Afterwards, different approaches to these challenges are discussed and last but not least, topics such as the integration of a pragmatic risk analysis or the use of a suitable tool framework are discussed.
Agility & Validation. A clash of cultures?
Meanwhile, it is no secret that we live in a dynamic, volatile, fast changing world, also referred to as “VUCA world.” Due to the on-going digital transformations, this state is irreversible, whether we like it or not. The globalisation has transformed our world into one large unpredictable fast changing and complex system. It is legitimate to say that digitization is a revolution comparable to the Industrial Revolution and is leading us into a new age. The whole market situation can change overnight, and companies do have to be able to react/adapt to that in order to remain globally competitive. Every company has a new boss who lay off anyone else in the company: the customer. Our customers (internal or external) are becoming more and more demanding. For example SAFe 5.0 is regarded as one of the most successful agile frameworks, which states business agility as the top priority for each company and defines it as follows:
Business Agility is the ability to compete and thrive in the digital age by quickly responding to market changes and emerging opportunities with innovative business solutions.
Software industry recognized this development some time ago and has reacted very successfully by introducing agile methods like Scrum or XP. Nowadays, after about 20 years (Agile Manifesto is from 2001!), Scrum is successfully established as a software development method in many places.
However, on the GxP validation side, a classic linear procedure (e.g. Waterfall-model) is still very often established. The V-Model is typically implemented by following a classical linear (waterfall) model, which sequentially runs through different phases. Typically: URS->FS->DS->Implementation->IQ->OQ->PQ
Changes to product requirements during the lifecycle of the project should therefore be avoided, as this means that individual phases cannot be completed or must be updated which inevitably leads to increases in overall cost, reduction of return on investment and delay in time to market.
Optimize the Agile & QA relationship
Agile product or software development is focused on maximizing product value and hence needs flexibility. Validation is focused on maximizing quality and reliabilty and therefore needs stability and long-term planning.
For maximum efficiency, i.e. the optimization of the relationship between value generation and quality level, validated system development must as a result include both the aspect of flexibility and the aspect of quality assurance (stability). It goes without saying that these are contradictory requirements in themselves and that the solution associated with them is not trivial. It requires not only interdisciplinary knowledge such as validation or QA expertise, technical software development or domain know-how, knowledge of the right tools, and much more, but above all a common mindset and a common understanding of goals or a product vision across different areas of the company. This can be a huge challenge for many project staff and teams at present.
Wega is sponsoring and exhibiting at the Paperless Lab Academy® since practically its beginnings and will be running a workshop and presentation as Premium Sponsor at the next edition in April 2021.
Mathias Fuchs , IT Consultant & Scrum Master at wega
Mathias Fuchs is certified Scrum Master, IT Consultant and since 2011 Co-Moderator of the non profit event series: Agile Breakfast Basel within the Swiss ICT Lean-Agile-Scrum expert group. For several years he has been dealing professionally and privately with the reasons for success or failure in the introduction of agile
software development methods and agile transformations. He is
working actively as Scrum Master in different validated software projects that are lead using agile frameworks.
wega Informatik is your service provider specialised in the Life Science, Pharma and Healthcare industry. Our unique combination of Business, Process and IT knowledge enables us to fulfill our demanding mission: “Building the bridge between business and IT”
We offer comprehensive, sustainable and high quality services. Our employees possess deep expertise due to holding a dual qualification in the scientific as well as in the technical domain. Our core skills range from Lab and Research, Clinical Development and Healthcare to Computer System Validation. A continuously growing, excellent network of highly specialized temporary contractors and freelancers complement our competencies.
Having acquired more than 25 years of experience and a very high customer satisfaction, wega Informatik is one of the most established and well-respected service providers within DACH.
Since 2019 wega is ISO 9001 : 2015 certified. Quality and customer orientation have always been the focus of wega and this certification formally underlines it. To achieve this, we have implemented our own digital quality management system: the expertise we have gained will directly benefit our customers.
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