Qdossier Case Study

How we helped Qdossier turn their vision into an end-to-end robust application with high-security standards 

Summary

Qdossier has been providing consultancy and services for the pharmaceutical industry for the past 15 years. Among their client base they have small and big pharma companies, innovative and generic drug companies and well established and start up customers. 

A few years ago, Qdossier identified a business need for an eCTD viewer tool that would support pharma companies with their eCTD life cycle management and submission of eCTD, NeeS, and other regulated dossiers. Qdossier envisioned creating a powerful tool with advanced capabilities of viewing regulated dossiers across multiple geographies and products, unlike anything else available on the market.

Because Qdossier had never developed a software product internally, they were looking for a software partner to advise and develop this platform end-to-end, through the entire software lifecycle. The key criteria for selecting a software development partner were transparency and trustworthiness.

Showcase results

Achievement-1

Built end-to-end a robust application with high-security standards 

Achievement-1

Built a successful MVP and then transitioned to a dedicated development team

Achievement-1

5+ years of partnership

Challenge

Qdossier is an experienced and reputable consultancy and service provider in the life science arena. However, product software development was not their area of expertise.

To bring their vision to life, Qdossier realized they needed to work with a skilled software development partner and entrust that partner with the development and technical decisions. Qdossier was looking for help throughout the entire software development process, from defining specifications and formulating user stories, to creating the product architecture, coding, deployment, and testing.

Their challenge was to find a reliable and trustworthy partner, who can translate the business needs into working features and who can understand and comply with the strict security and regulation requirements of the pharmaceutical industry (such as regulations from Health Authorities and standards such as GAMP and 21CFR Part 11). 

Solution

In 2016 Qdossier decided to partner with Wirtek in developing an MVP of Dossplorer™, the regulatory dossier viewer. Their decision to collaborate with us was based on our technical expertise, endorsement from former clients, and good communication and processes. The positive initial interactions with our technical team and the fact that we were very transparent as to how we handle code and IP rights reassured our client that they were in good hands.

We met with the Qdossier team in Cluj Napoca and discussed their software development needs, walked them through our process, and advised on the next steps. Our collaboration started as a Time and Materials engagement, and the first task was to define specifications. Having a clear grasp on our client’s vision for the product was crucial in defining the requirements, so our team worked closely with the Qdossier team in defining specifications, user stories and creating estimations and delivery timelines. 

Because the Qdossier team had never used Agile methodologies before, our team advised and supported them to adopt the Scrum framework, coached them on how to write user stories, as well as set up tools such as Jira and TestRail. At the same time, we had to understand the inner workings of the documentation and validation processes in the pharmaceutical industry, so it was a learning process that we went through together.

Once we had the specifications ready, we moved on to creating the product architecture and then development and testing. When the MVP was ready, the development of new features was slowed down so that Qdossier could gather feedback from prospects and customers.

The pharmaceutical industry is highly regulated, so it was very important to create detailed technical product documentation showcasing the reliability of everything that we developed. 

Security is another critical aspect of a pharmaceutical software product and in 2018 we assisted Qdossier in conducting a penetration test with an external provider. 

Today we have a dedicated team of software engineers building new functionalities requested by Dossplorer users and integrating with other tools to create an end-to-end solution for pharma companies. The team in Qdossier and Wirtek work as a single Scrum team, on 2 weeks development Sprints. Quality is the responsibility of each team member of the Scrum team and we perform extensive tests before any release.

Our goal as a development team is to provide an enterprise-class product (in terms of functionality, security, performance indicators & reporting) and we believe that the proactiveness and dedication of our engineers enable us to reach it.

Services

technical-support
Architecture & High-Level Design
technical-support
Custom Software Development
technical-support
Software Engineering Best Practices
technical-support
Usability & UX
technical-support
Agile Product Development
technical-support
Security Testing

Results

We are proud we helped our client realize his vision and turn a concept into a product. We managed to develop a complex and robust application, with a solid IT architecture and high-security and QA standards. We are currently working with Qdossier to enhance Dossplorer with new integrations (eg Okta, SSO with Ping) and improved functionalities (advanced search, reporting, data extraction).

Through our collaboration, our team acted as a consultant to our client, not only a development partner (advising on the IT architecture, Scrum framework, customizations, and more). 

Ensuring the quality of a pharmaceutical software product is a complex task due to strict security and regulation requirements of the pharmaceutical industry (eg. regulations from Health Authorities and standards such as GAMP and 21CFR Part 11). 

Trust, good communication, and transparency have been the pillars of our collaboration from the start. Qdossier sees our colleagues in Wirtek as part of their team and they rely on us for technical advice and solutions. In turn, our colleagues are dedicated and invested in making Dossplorer a successful product. They are empowered to decide on the best technical solutions and propose new features and improve existing ones.

Technologies and Frameworks

  • .NET framework 4.7 (C#)
  • MVC 5.2.7
  • Entity framework 6.4.4
  • ADO
  • Bootstrap 3.4.1
  • Kendo UI
  • jQuery

Tools

  • Jira
  • Gitlab
  • TestRail
  • Visual Studio
  • Microsoft SQL Management Studio

Client testimonial

About Qdossier

Qdossier realizes efficient recording and exchange of the proof of quality, safety and efficacy of medicinal products since 2006.

Qdossier offers consultancy, services and solutions. Consultancy includes regulatory affairs all-round support and process development and solution implementation. Services include data, document and dossier management. Our solutions are DossplorerTM, a dossier / eCTD viewer; DosscriberTM, CTD document templates; and DossignerTM, a tool to design eDMS configuration and dossier outlines.  

More at www.qdossier.com

about-qdossier-1180x860

Testimonials

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