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

Summary
Qdossier has provided consultancy and services for the pharmaceutical industry for 15 years, serving both small and large pharma companies. They identified a need for an electronic Common Technical Document (eCTD) viewer to support pharmaceutical companies with eCTD lifecycle management and submission of eCTD, NeeS and other regulated dossiers. The envisioned tool needed advanced capabilities to view regulated dossiers across multiple geographies and products. Since Qdossier had never developed software internally, they sought a transparent, trustworthy software partner.

Showcase results

• Built end‑to‑end a robust application with high‑security standards.

• Built a successful MVP and transitioned to a dedicated development team.

• More than five years of partnership.

Challenge
Product software development was not Qdossier’s area of expertise. They needed a skilled partner to handle the entire software development process—from defining specifications and creating user stories to product architecture, coding, deployment and testing. The partner also had to meet strict security and regulatory requirements, including standards such as GAMP and 21 CFR Part 11.

Solution
In 2016 Qdossier partnered with Wirtek to develop an MVP of Dossplorer™, a regulatory dossier viewer, based on our technical expertise and endorsements. Positive initial interactions and transparency on code and IP rights reassured Qdossier. Collaboration steps included:

• Meeting in Cluj Napoca to discuss needs, describe processes and define specifications.

• Adopting the Scrum framework: Wirtek coached the Qdossier team on user stories and tools such as Jira and TestRail.

• Building product architecture, development and testing.

• Slowing feature development after the MVP to gather feedback.

• Producing detailed technical product documentation to demonstrate reliability.

• Assisting with penetration testing in 2018 to ensure security.

Today a dedicated team builds new functionalities and integrations (e.g., Okta, SSO with Ping) and works as a single Scrum team. Quality is everyone’s responsibility, and extensive tests precede releases. The team aims to provide an enterprise‑class product through proactiveness and dedication.

Results
Wirtek helped Qdossier realise their vision, developing a complex, robust application with a solid IT architecture and high security and QA standards. Ongoing work includes adding integrations and improved features such as advanced search, reporting and data extraction. The collaboration is built on trust, good communication and transparency. Qdossier sees the Wirtek team as part of their own and relies on them for technical advice and solutions; our colleagues are empowered to decide on technical solutions and propose new features.

Technologies and Frameworks
.NET Framework 4.7 (C#), MVC 5.2.7, Entity Framework 6.4.4, ADO, Bootstrap 3.4.1, Kendo UI and jQuery .

Tools
Jira, GitLab, TestRail, Visual Studio and Microsoft SQL Management Studio.

Client testimonial
Hans van Bruggen, Owner and Senior Regulatory Affairs Scientist at Qdossier, says that Wirtek helped build Dossplorer, a robust and complex application with high‑security standards. He praises the team’s eagerness, problem‑solving orientation and pleasant, open communication, noting that they act as consultants and advise on product architecture, Scrum methodology, technology and tools. This testimonial repeats throughout the page.

About Qdossier
Qdossier enables efficient recording and exchange of proof of quality, safety and efficacy of medicinal products. It offers consultancy (regulatory affairs support, process development and solution implementation) and services (data, document and dossier management). Its solutions include Dossplorer™, an eCTD viewer; Dosscriber™, CTD document templates; and Dossigner™, a tool to design eDMS configuration and dossier outlines.