Easily adaptable and Agile even in the highly regulated pharma industry

Amplexor wanted a team that would not only be a technical fit, but whose seniority experience will bring improvements to their LifeScience Suite.

Easily adaptable and Agile even in the highly regulated pharma industry
Client name
Amplexor
Industry
Pharmaceuticals
Location
Zagreb, Croatia
Services
Dedicated Team
Methodology
Agile, Scrum
Technology
Java
Team size
17
Project duration
3 years

The Client

Amplexor is a global provider of regulatory, quality, and safety software solutions that helps pharmaceutical, biotechnology, and medical device companies achieve process efficiency. Their solutions offer end-to-end support for product lifecycle processes, data, and content management, reducing time-to-market and increasing revenue generation. 

Client Challenge

Amplexor had a variety of feature versions their clients customised according to their needs and size. All versions had to be continuously tested and optimised, as well as each client had an option to add new functionalities to fit their processes. On top of that, Amplexor’s software is highly regulated by the pharmaceutical industry, and frequently audited by their own clients to ensure they comply with industry standards. In addition, the Amplexor team worked from three separate locations using different tools and in the waterfall method. 

The Project

Amplexor Regulative Information Management (RIM) system, called LifeSciences Suite, is an end-to-end holistic solution for following the whole regulatory process, from research and registration to communication with EMA, FDA, and similar agencies. It also includes features that take care of Quality Management and any Corrections the customer may need about their pharmaceutical products. 

Project Goals

Nightly regressions
Devise a system to run nightly regression feature tests for the platform and make sure that all per-customer customizations stay compliant after test runs.
New possibilites
Develop new functionalities and write appropriate tests.
Rewrite the platform
Create architectural software documentation for rewriting the old platform to new.
Improve process model
Navigate the transition to Agile and Lean principles and improve process model.

Results

1
Established operational efficiency with nightly regression test even though at all points in time there were at least 2 thousand users online
2
Followed all regulatory requirements for new regulations, features and software updates
3
Never missed a crucial time to marketthanks to the engineer’s quick adaptation to proprietary software and industry regulations
4
Created Gartner-approved architectural software documentation
5
Improved the outdated code and product with senior’s technology knowledge and experience
6
Achieved higher predictability of delivery dates of new releases, as well as higher efficiency and transparency of work and easier prioritisation of urgent features with Agile approach

How did we do it?

Product Discovery

Familiarise the team with the platform, how it works, and how to develop new features on monolith architecture while maintaining backward compatibility

Fullstack Development

Develop new features for the platform while maintaining backward compatibility and all customizations for existing customers

Consulting

Overview of the current methods showed Amplexor was using waterfall and V-shaped for process governance, and that departments used various set of tools
Plan out transformation stages to Agile which included strategy definition, team education, piloting of the strategy (transition goals, approach and actions) and rollout to the rest of the organisation
Select strategy goals for the transition with Amplexor leadership and rollout accordingly

Technology

Java
JSP
Documentum DMS
Maven
Geb
XML
Selenium
Spock

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