Polpharma biologics

Complex ITSM implementation for the top company from the pharmaceutical industry

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Leader of innovation

Polpharma Biologics is a relatively new and innovative company; however, being part of Polpharma, it has nearly a century of history. The company develops and manufactures biosimilar drugs in three sites in Poland and the Netherlands. With over 700 people and 10 000l bioreactor production capacity, it is one of the biggest biopharmaceutical companies in Europe. Polpharma Biologic, with its pipeline of novel biologics and biosimilars, is currently working on two innovative drugs and has seven molecules in the portfolio of biosimilar drugs.

Main challenge: fulfilling sector regulations

Polpharma Biologics needed an IT Service Management tool that is stable and fulfills strict pharmaceutical regulations. Introducing changes to an IT system has to follow a specific validation process, covering documenting the solution, defining an adequate level of testing, and providing evidence of performed tests. All those components need to allow full traceability. 

ServiceNow validation proces

To implement the ServiceNow ITSM, Polpharma Biologics chose SPOC as a partner. The main goal was to meet complex pharma industry-related validation and ensure high-quality, holistic testing and required documentation. After the scoping workshops, SPOC prepared a User Requirements Specification document as a key prerequisite for starting the design and delivery phase, launched after the first product workshop. It led to the delivery of all requirements, tests, and documents. SPOC provided the process owners and practitioners as well as the end-user community with the platform training. The SPOC PPM tool supported the creation of content of documents used in the validation process (FS, DS, CS), provided input to traceability matrix (RTM), and generated formal pieces of evidence in the testing process. Once validated, the ServiceNow ATF tool allowed regression testing to support Customer in platform upgrades, new ITSM modules implementation, or creating specialized business applications based on ServiceNow.rnrnThe first release covered platform’s Core Configuration, CMDB and Asset Management, Incident Management, Change Management, Service Portal and Service Catalogue, and Automated Tool Framework areas. The project ended successfully, and Polpharma Biologics is currently working with the ServiceNow platform, planning further developments.

Our perspective

Marta Piotrowska

Most of the challenges in the recently completed ServiceNow ITSM implementation resulted from validation requirements. It was successfully resolved thanks to the very close cooperation of team members, their analytical skills, and strong commitment from SPOC and Polpharma Biologics.

Marta Piotrowska

Senior Project Manager at SPOC

As a team we gained another great opportunity to deep dive into the pharma industry and its requirements when it comes to delivery of the project with all the other fundamental activities needed for the pharma business. We worked through it together tackling all the internal and external components to deliver products meeting all the stakeholder needs.

Karol Skałowski

Engineering Manager at SPOC

Senior Project Manager

Engineering Manager

What distinguishes this project?

Close cooperation

The project was challenging due to the specificity of the pharmaceutical industry and process validation. The key to success was analytical skills and strong commitment from both the SPOC team and Polpharma Biologics.

Solutions variety

The project covers various services like IT Service Management Products, Key processes synchronized via setting the respective workflows with the GxP process, PDF Generator (native SPOC app), Process Consultancy / Advisory.

ServiceNow benefits for Polpharma Biologic

One IT system that meets all the pharmaceutical industry requirements, like qualification process (IQOQ) and access to the ServiceNow CORE for Life Sciences (Compliance Operations Readiness Evidence) documentation

ITSM processes maturity automatically shifted up through the implementation of the platform getting best practices and automated workflows

Great base to evolve further enhanced by the respective piece of documentation as well as training

Regulatory and business needs reflecting in the platform

Built-in workflows and processes with high agility, flexibility and scalability

Structured and transparent framework for IT processes

What does the client say?

We play in the champions league, and we cannot afford uncertainty. The number of implementations of the ServiceNow platform globally was of great importance to us.

Bartłomiej Piernicki

Director Business Technology at Polpharma Biologics

For the first time for us, such an extensive IT system works entirely in a validated environment. This project equals accumulated experience, which we will use to end each implementation successfully in future IT projects.

Ireneusz Smoliński

IT Service Management & Application Manager at Polpharma Biologics

The SPOC company has gained our trust thanks to their knowledge. The design team consisted of people who knew the technology. SPOC employees have a passion for the development of the ServiceNow platform but also for working with people. We are committed to building partnership relations, and we have certainly succeeded.

Michał Kruszewski

IT Manager at Polpharma Biologics