Working in an Agile way in highly regulated environments like healthcare can raise significant challenges. Managing design history files, e-signatures, and other electronic records and approvals across platforms can become extremely complex. Although they were already using an ALM (Application Lifecycle Management) tool, Roche Diagnostics found themselves at a turning point in their Agile transformation and realized they needed a different platform to help them better manage electronic records. They ended up choosing codebeamer – read on for the whole story!
The Roche Diagnostics team knew they wanted a plug-and-play system that would allow them to implement complicated customizations to optimize their product development efforts, but struggled to find the right match on the market until they came across codebeamer. Using codebeamer’s segregated objects in the form of workflow items, Roche Diagnostics was able to build custom building blocks over the platform's configuration, allowing for very specific customizations without disrupting the tool’s UI.
In a webinar session, we sat down with Max Poprawe (Product Manager Requirements Management and Testing at Roche Diagnostics) to find out a little bit more about how they transformed key requirements management processes with codebeamer to create a clear, high-performing, and easy-to-maintain system which empowers Agile ways of working. A summary of the insights from this webinar follows – to watch the webinar, scroll right to the bottom!
Product Manager Requirements Engineering & Testing, Roche Diagnostics
Traditional requirements management: content duplication and chaos
When it comes to managing requirements and design history files in product development, teams tend to draft them in Excel or some other easy-to-use application first – especially in the beginning when things tend to change a lot. While that’s alright to start with, at some point they will need to be shared with other colleagues and across teams for feedback.
Inevitably, proposals come up, changes are made, and before you know it, information becomes duplicated or lost. Now the same requirement exists in three places at once and nobody is sure what the final version is supposed to be. At this stage, the requirements manager gathers all these inputs and changes, consolidates them, and eliminates duplicates, which requires a lot of time and effort. Now the requirements are submitted to an ALM tool, where they are systematically moved from draft and to the approved status.
Managing design history files (DHFs) and the cost of document exportations
Digital approval management has several steps. After being approved in the ALM platform, requirements (and any other design documentation a DHF may contain like test cases, executions, defects, planning, reports and more) are put through a document generator that translates the data from ALM into another format. These document exportations take a colossal amount of time and resources.
According to Max, “some of them spend 2000 man-days, that is to say, four and a half man-years on document generation. Some projects continuously have two people employed just extracting and bringing into correct format objects out of an ALM tool into documents.”
The result of the document exportation is sometimes an Excel, sometimes a Word Document, and sometimes a PDF. This document then finds its way to the EDMS (electronic document management system), where it lives in PDF format with a stamp that makes it an official document. The EDMS is the first port of call for an auditor or regulatory body to review documents in their final, formal form, in order to determine compliance with standards.
Status quo for managing electronic records: too many hoops to jump through
At this point, Roche Diagnostics found itself at a significant crossroads. The process of transferring requirements between platforms and formats for approval, sign-off, and review doesn’t happen once, but many, many times. It happens for every single version of products that the team puts out. This means there can be many versions, which makes it incredibly difficult to track changes and know what is truly approved or not.
Max and his team wanted to find a way to generate the necessary documents in their ALM platform itself, without exporting them to an EDMS. But they had to take on the following challenges into account first:
- Approvals: item approvals need context i.e. who is it being approved for, which release or set of releases does the approval apply to, which version is approved, etc
- Sign-offs: e-signatures management is vital for the product lifecycle and for compliance. Knowing when and where to sign, when the signature is actually necessary, is vital for moving on to the next steps
- Hotfix releases: the team always needs to be able to hotfix an old version of the product if necessary, as well as add or update a requirement and make a release out of that
- Traceability: they need to be able to clearly link both objects and changes throughout a product lifecycle for change management and compliance
- Product complexity: the system needs to cater to all different sizes and complexities of products, whether it’s an app or a billion-dollar research project for a room-sized medical device.
How Roche Diagnostics turbocharges requirements management with codebeamer
Moving requirements from an Excel, to an ALM platform, to an EDMS platform is a cumbersome process that often leads to content duplication and out-of-date information.
Using codebeamer, Max and his team were able to develop two key methods which optimized their requirements management process, automated where possible, and addressed the above challenges.
Let’s take a closer look:1) Multi-release tagging: This is a mechanism used to give items much-needed context in order to facilitate steps like approvals, sign-offs, and traceability. Using codebeamer, Max and his team link objects in different trackers (for product requirements, technical requirements, test cases, or any other object type) to release objects.
Max elaborates on the distinction: “We don’t tag objects in the release they get introduced in, but rather, we tag objects within all releases they are supposed to be in or are relevant to.” That way, the team can track the progress of requirements and see what the scope is for each release they’re connected to.2) Release scope tracking: Hang on, what if you need to sign off on the requirements but not the release? This takes place in stages, with signatures coming in at different times. And if one item changes along the way, then the release tool should not just accept a new version of the item; it should force a re-signature. This is where release scope tracking comes in.
These are items that help manage the scope of a release in light of the different individual tracker. The release scope tracker connects the item tracker to the release tracker, allowing the team to control which customer requirements are in which release. On top of that, it also gives auditors easy access to a simple way of seeing the changes that occurred in different revisions in the scope history.
Max outlines the following as key benefits which came about as a result of using the above methods with codebeamer:
- Increased efficiency
- Built-in compliance
- Faster time-to-market
What comes next in Roche Diagnostic’s digital transformation journey
Max summarizes their new style of requirements management with codebeamer as follows: “The idea is that you create it in the tool, and it stays in the tool.” But this Agile way of managing requirements certainly requires a mindset shift.
Max explains: “It’s not an import – it’s more of a change of mindset. It’s going away from saying our DHF is PDFs that are rendered in an EDMS, it’s saying our DHF is distributed, some of the documents are in EDMS and PDF form, some of them are electronic records with a signature and they sit in codebeamer.”
Moving forward, Max and the team at Roche Diagnostics will be focusing on further refining the process, completing defect scopes, and finding more ways to leverage codebeamer to streamline electronic records management.
For more detailed information about Roche Diagnostic’s journey, check out the webinar here: