Meet our V&V manager Rafael!

We are happy to present our Verification & Validation manager, Rafael. As he wants to share his knowledge and experience in verification and validation of software development, we’d interview him about his vision and passion at Quadratek Data Solutions and Clincase. Here he explains how, through the V&V process, he wants to deliver a well-crafted product for our customers.


– Could you explain your role at Qaudratek Data Solutions?

Rafael: My role is to develop and implement standardized procedures and policies for verifying and validating software in a highly regulated industry like the one we are in. My main focus is to improve Software Development Life Cycle (SDLC) process in accordance with Agile methodologies like Scrum, Kanban, SAFe, and TIR 45, which is particularly used in medical device software development.


In other words, my role is to develop, implement, and execute certain strategies on how we can improve our process in order to fulfill our customer demand. I must ensure that all development projects are following the defined development process by testing features and reporting the results during and the development cycle not only at the end.


– What’s your experience in V&V?

Rafael: I’ve been working for 11 years in software development while executing different roles such as Software engineer, Product Owner, Scrum master, Software development process engineer, and Software development leader. I have sufficient knowledge in Agile and coached software development team and Product Owners in the methodologies mentioned above which strengthened my skills in people management.


Working as Software development process engineer has equipped me with certain knowledge like software requirements modeling, code design, developing, testing and automated testing, verification and validation. With my previous work experience I am confident in the Java Enterprise platform and its surrounding technologies like Hibernate, EJB, Struts, jBoss, Tomcat, Spring, JSP, Ajax, Java Script and so on. I am certified in Certified Scrum Master (CSM), Certified Scrum Product Owner (CSPO), Certified Scrum Developer (CSD), SAFe Practitioner, Sun Certified Web Component Developer (SCWCD), Sun Certified Java Programmer (SCJP) and Oracle Certified Associate (OCA).


– Could you explain what Verification and Validation in software development is?

Rafael: Every software development process should ensure customer needs and expectation to be fulfilled. This is Software Validation, which means that you built the right thing. If the software is coded under the right system requirements, this is called Software Verification, which means you built it right. Our aim at Clincase is to fulfill customer expectation, not only at the end of the process but also during the process. Developing software in regulated industries, like the pharmaceutical industry, Software Verification and Validation are even more important than usual. In short, the goal of V&V is to ensure we deliver customers a well-crafted software.


In details, good practiced activities in V&V should include maintaining traceability of requirements, test cases and its results, and updating the entire software documentation such as user manuals, release notes, software requirements. And it includes performing system testing like regression, user acceptance, integration tests during the process, after each sprint, and before the release


– Then what does Verification and Validation mean to you??

Rafael: In my point of view, the quality of a product is directly connected to the quality of its process. Whether we are or not in a regulated environment, we should focus on continuous improvement of our process, always aiming to delivery better software solutions with high quality standards that fulfill user needs.


– Lastly, how do plan your future at Clincase and QDS?

Rafael: I hope to contribute my knowledge in agile methodologies, Software Development Life Cycle, and people management for improving our process to be more efficient and effective in order to delivery our customers the well-crafted software, Clincase. Overall my aim is to improve quality of the software development process. In order to do so, I must work with my team. I need to gather inputs from our team who actually operate the process and are the best ones who can give me valuable ideas how to improve its process.


Introducing our Quality Assurance Manager

We, QDS and Clincase, are happy to introduce our Quality Assurance Manager, Secil. Here is her talk about her motives and vision at Clincase.


-What do you do at Clincase? 

Secil:  As the Quality Assurance Manager, my role is to ensure to implement the Quality Management System, encompassing all aspects in the company, as a part of the daily routines. Nowadays, we are highly focused on the controlled documents aligning with the processes and industry regulations.

In addition, we are working in collaboration with the department Quality Assurance Representatives in order to ensure all functions in the company have sufficient qualification for conducting their tasks. Hence, we’ve improved our training process accordingly and planned several trainings related to quality and technical awareness. We realize that we could only achieve the maximized quality when involvement of the qualified team is fully devoted to our quality policy and continuous process improvement.


-What’s your background in Quality Assurance?

Secil: I have 7 years of background in quality assurance particularly related to ISO9001, Lean manufacturing systems and problem solving techniques. Before joining the QDS team, I was working in a global company and my role was to implement and train employees with the related production systems in the shop floor such as ISO9001, Lean Administration and Total Productive Maintenance (TPM) including 5S, Autonomous Maintenance, Poka Yoke and Project Management. During the implementation phase, we used several problem solving methodologies such as the 6 Sigma, Kobetsu Kaizen and Figure 8 methods.


-Then what does it mean to have the Quality Management System for Quadratek Data Solutions?

Secil: QDS is an important Electronic Data Capture (EDC) system provider in a highly regulated industry and thereby must comply with the related regulations and laws. Accordingly, QDS has a high focus on the quality and maintains the Quality Management System effectively since 2004.


-What does the Quality Assurance personally mean to you?

Secil: As you know, everybody in the organisation has different roles in order to contribute to its services and maintain the entire organisation. For me, the role of the Quality Assurance Department should be gathering all these different roles in a commonly shared quality perspective and drive the team to its defined vision. Of course this could be only possible when everyone in the team participates and accepts the quality as a part of daily life.


– How can you contribute to QDS and Clincase, do you have plans for the future?

Secil: In the short term, our plan is to improve Corrective Action & Preventive Action (CAPA) process flow for internal topics as well as the audit feedbacks in order to have a systematic methodology to be able to see all items in a single common system. Also, we would like to increase the role of quality in the main processes by involving the development steps with the planned risk analysis and the design reviews in coordination with the Validation & Verification Manager.


Out of Albrechtstrasse and into Feuerland

After 10 years, Clincase has outgrown its space and has recently moved to a new office just around the corner from its former Albrechtstrasse home. Still located in Mitte, the center of Berlin, Clincase is now housed in an even more spacious and open office environment in order to accommodate our growing staff and to meet the increasing demand for reliable and flexible eClinical Technology Solutions.

Our new offices at Novalisstrasse 10 are located in the heart of the neighborhood formerly known as Feuerland (or Fireland), a corner of Berlin that was forged from the grit and steel of the Industrial Revolution. The courtyard where Clincase is now situated, once housed railroad magnate and titan of German ingenuity and engineering, August Borsig’s metal and ironworks foundry. It was from this site that Borsig built his powerful steam locomotive which came to dominate the European railways in the mid to late 1800’s. The name “Feuerland” refers to the massive cloud of smoke that was ever present and could be seen in the skies around Berlin as a result of the work being churned out at this site.

Novalistrasse 10, is now fully-renovated, more environmentally-friendly and is host to a growing number of technology and creative firms, Clincase included. If you would like to know more about the history of the Novalisstrasse and Borsig’s Feuerland, have a look at this site (all text in German).

KCR Forges Ahead with New Clincase-Based Platform

Earlier this year, KCR, a trusted Clincase partner, announced its development of a new clinical trials data management platform built on top of the core Clincase electronic data capture (EDC) and clinical data management (CDM) software.

“…the platform is cost-effective and therefore attractive for both biotech and mid-sized pharma companies… We focus on providing innovative, world-class solutions to all our clients and we are committed to doing so… Our cooperation project with Quadratek provides KCR with an advanced technology solution to respond to market needs such as Risk Based Monitoring (RBM) or to industry efforts to increase the level of clinical trial transparency.” said Mike Jagielski President & CEO of KCR.

To learn more about KCR’S development of a Clincase-based CTMS click here.

Quadratek Data Solutions Exhibited at the 27th Annual DIA EuroMeeting in Paris, April 13-15th, 2015

The Clincase team participated this April in the 2015 DIA EuroMeeting which was held this year in Paris.  The DIA EuroMeeting and other annual events are excellent places to find out about new developments in the life sciences and associated industries. It is also great place to network and meet up with our existing and prospective partners.

To learn more about the DIA EuroMeeting and the plethora of conference and events that DIA has worldwide visit their website.

Come join the QDS Team at the upcoming 13th DVMD Fachtagung in Ulm

Our team is proud to announce that we will be participating in the DVMD EDC Challenge on March 12th, 2015. Come join us at the Hochschule Ulm from 15:20 – 16:45 for an introduction to the basics of the Clincase system. We will be presenting standard data entry functionality, showing different layout possibilities and demonstrating how cross visit data checks can be implemented. We hope to see you there!

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