PolyPeptide determined a need to implement a new QMS for IT that was global, up-to-date, and in alignment the necessary industry regulations.
In the end, PolyPeptide gradually went live with an IT QMS that supported their local operations, global company, and rapid growth.
IT projects will always have an impact beyond the scope of the project team. This may seem obvious in today's connected world, but still one of the biggest challenges for IT projects is ensuring the involvement of all the right stakeholders. For Life Science companies, any challenges are magnified by industry compliance requirements.
In 2019, PolyPeptide determined a need to implement a new QMS for IT that was global, up-to-date, and in alignment the necessary industry regulations. To achieve this goal and deliver efficient, cost-effective, and stable IT services to the organization, PolyPeptide needed to gather a clear understanding of IT compliance requirements for both their business needs and the industry.
Over the past few years, PolyPeptide and Epista have worked together to secure greater control over PolyPeptide's global IT infrastructure and applications, and to develop processes that can support their IT environment and adhere to the Life Science industry. From the start, the team at PolyPeptide understood that the optimal way forward was to invite an outside team in to assess the situation at hand and provide support as subject matter experts for industry requirements, project management, and change implementation. This is where Epista Life Science joined the project to help identify the gaps in their QMS, set a plan for both new and existing SOPs, and strengthen the collaboration between IT and QA.
To develop an IT QMS that could adapt and grow with the company, PolyPeptide went through a holistic process. This meant first getting an understanding of the existing IT QMS, determining what worked (and what didn't), and aligning this with future goals. Through structured meetings and discussions, PolyPeptide determined a clear end goal for their new IT QMS: to harmonize the system globally. Aligning IT processes globally is no easy task, but with a distinct goal now in mind, the project could move forward more strategically.
To start, Epista worked with the team at PolyPeptide to develop and deliver an IT compliance roadmap that included details on the QMS framework, the content to be included in the new QMS, a high-level timeline, and the business impact that this implementation would have on PolyPeptide's business. Once the roadmap was in place and the team had a better understanding of IT compliance activities, the QA strategy, and overall QMS activities, Epista could begin to evaluate the current status of Polypeptide's SOPs and documentation.
Now that the goal was clear, the team had to evaluate existing SOPs, determine which should stay, which should be retired, and what new SOPs or policies might be needed to create clarity within the PolyPeptide QMS. This included defining ownership and roles for new processes. In addition to the IT QMS itself, the team also assessed the IT QMS SharePoint site and determined what could be saved, moved, or decommissioned in preparation for future migration to the new QMS.
Once the SOPs and other relevant templates, policies, and procedures were scaled down, it became easier to determine what was missing. With Epista's help, PolyPeptide worked hard to globalize their IT QMS. They did this by paring down the number of SOPs in their QMS by eliminating as many local procedures as possible and, where necessary, replacing them with globalized ones that work across business locations.
Prior to this IT compliance project, PolyPeptide’s local offices had Computerized System Validation (CSV) SOPs.However, at these local sites, the procedures were often split up into multiple documents, making it difficult to get a clear overview of the entire process. As a part of the IT Compliance project, the CSV procedure was both simplified and compiled into a single document / SOP that is now used globally across PolyPeptide sites.
With SOPs in place, it was then time to ensure that everyone understood the roles, new trajectory, and how to best utilize the updated processes and procedures. Epista's expert and Principal Consultant Karin Hesslevik worked with the team at PolyPeptide to train them on the new SOPs with a focus on the area of IT compliance - an area where the company was determined to grow their competencies and better support their rapidly growing business.
Training and support also included Epista’s participation in operational activities to strengthen IT compliance and increase regulatory requirement awareness in day-to-day work.
Stakeholder Alignment and Collaboration
In order to create an up-to-date and harmonized IT QMS, all relevant stakeholders must be both involved and aligned on the needs and processes of all parties. Aligning stakeholder needs is a challenge across industries and companies. And one common challenge when it comes to systems and processes that cross departments is understanding the requirements of each department. In this case, IT needed to better understand QA and QA needed to better understand IT. Any misalignment between these two main stakeholders within IT compliance makes it more difficult to navigate day-to-day operations and, consequently, more difficult to implement an IT QMS that would meet everyone's needs and ways of working while still adhering to industry regulations.
IT Compliance & Regulations
In the Life Science industry, the challenges of implementing an IT system go far beyond simply selection and implementation. There are also an abundance of ever-evolving rules and regulations that the IT system must be in alignment with. At PolyPeptide, this meant ensuring that the IT department developed and set clear standards that supported operating an IT system in the Life Science industry (e.g., administering change controls).
As with many IT projects, determining the need for the right amount of resources can always be difficult. Often times, more and more stakeholders get added to the project and new challenges arise. PolyPeptide was actively growing when their project began. That meant that staffing was changing and acquiring people for project support occurred in parallel with the project. In addition, the changes brought on by the IT QMS implementation required more QA resources on a global scale. Prior to kicking off their project, PolyPeptide had plenty of local QA resources, but had yet to see a need for them on a global scale.
Collaboration & Relationships
When a project requires as many stakeholders as a new global QMS, it very quickly becomes clear that close collaboration will be required for a successful project – both during the project and after during operations. As aforementioned, understanding and close collaborationcan be a challenge when many stakeholders are involved. In this case, the team successfully combined input from Epista, IT, and QA. This included, for example, work on the SOPs from Epista Consultant Karin Hesslevik, a Global QA Specialist from PolyPeptide, and members of PolyPeptide’s IT department. Not only did Epista and PolyPeptide collaborate well together, but our collaboration’s foundation stems from years of working together on related projects. Long-lasting relationships are at the core of Epista’s values and PolyPeptide is just one example where this pillar has made a clear difference in the success of a project.
Knowledge & Experience
PolyPeptide knows their business well and Karin knows the ins and outs of IT compliance and business in the Life Science industry. The combination of these two core sets of competencies created th eperfect pairing for ensuring every required aspect of the project was covered by an expert. That meant that the team had the knowledge to ensure that every SOP and procedure not only met the strict requirements of the Life Science industry, but also met PolyPeptide's requirments to continue to run a strong internal operation.
In the end, PolyPeptide gradually went live with an IT QMS that supported their local operations, global company, and rapid growth. However, this project focused on more than just hitting play on a new IT solution. Instead, PolyPeptide and Epista developed a set of procedures with a purpose that can be adapted over time as the company shifts and changes.
At the time,this meant writing 25 new procedures, retiring 10 SOPs, and ensuring that many of the SOPs that went into the new QMS met the needs of the global organization in addition to the various local sites. And today, the flexibility that the team created for the system has allowed some documents to already go through changes and be re-approved to meet the needs of their bigger company.
We are very satisfied with our new IT QMS. It has been hard work for the whole department, but also very engaging and has given us a great foundation for our documentation. We appreciate all the work that Karin and Epista have done for us. - Thomas Lorentzon, Global Director IS/IT
At Epista, our goal is always to work with you to develop the best possible solution for your business and the Life Science industry. Whether you need new SOPs, guidance, support, or any other of our services, our experts can help you achieve your goals – no matter the size of the project. Reach out by contacting our expert below if Epista sounds like a good fit for your business.
*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR.
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