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For many German mid-sized life sciences companies, quality management evolves organically.
Paper records become spreadsheets. Spreadsheets become validated spreadsheets. Internal tools are built to bridge gaps. New procedures are added to maintain compliance. Over time, quality systems become increasingly difficult to scale.
The challenge is not whether these approaches work. It's whether they remain sustainable as organizations grow, regulatory expectations increase, and training requirements multiply.
For Coriolis, a German pharmaceutical development and services provider operating in both research and GMP environments, that tipping point arrived when paper-based processes and validated Excel spreadsheets were creating more administrative burden than value.
Rather than continuing to expand manual processes, Coriolis decided to build a quality foundation capable of supporting future growth.
Coriolis is a German service provider specializing in pharmaceutical development, formulation development, analytical services, and clinical studies. The company supports clients across both research and GMP-regulated environments while maintaining rigorous quality and compliance standards.
As the organization continued to grow, so did the complexity of managing documents, training, policies, and quality records across the business.
Before implementing Scilife, Coriolis managed quality through paper records supported by validated Excel spreadsheets.
Document approvals required printing, signing, stamping, scanning, and archiving records, while training activities relied on manual tracking and paper-based documentation. The system remained compliant, but maintaining it required increasing effort.
As regulatory expectations around spreadsheet governance grew, so did the administrative burden. Authorities accepted paper systems and Excel-based processes, but those spreadsheets had to be validated and supported by documented procedures describing how they were administered, reviewed, and maintained.
“We were still working with a paper-based system in the GMP environment, including printing, signing, stamping, scanning, and filing. One of my first priorities was to move away from that."
Bodo Brocks, Head of Quality, Coriolis
Rather than creating additional procedures to govern spreadsheets, Coriolis chose a different approach.
“We responded that we were going to implement an eQMS instead of writing instructions for how to handle Excel spreadsheets."
Bodo Brocks, Head of Quality, Coriolis
By moving to a GMP-focused electronic quality management system, the company reduced administrative burden while creating a more scalable foundation for future growth.
Before selecting Scilife, Coriolis evaluated multiple options.
Internally, the company's data science team had already begun developing a custom document and training management platform. At the same time, the quality team assessed several commercial eQMS solutions.
The largest enterprise platforms were quickly ruled out, since for a growing mid-sized organization, the team felt these systems would introduce unnecessary complexity.
Other solutions fell short for different reasons: Some lacked dedicated testing environments. Others relied on proprietary document editors instead of familiar Microsoft Office applications. Some focused primarily on ISO 9001 requirements rather than GMP-regulated operations.
Scilife stood out because it aligned closely with Coriolis' needs as a growing GMP organization.
The platform combined:
Most importantly, it allowed the company to avoid building and validating a custom system from scratch.
“Scilife had everything we were looking for: It was pre-validated, offered Office applications, we could implement a test environment, and it was truly focused on GxP and GMP requirements."
Bodo Brocks, Head of Quality, Coriolis
Validation was a major consideration during vendor selection. Building a custom platform would have required extensive validation, documentation, testing, and ongoing maintenance.
By selecting Scilife, Coriolis gained access to a validation-ready platform supported by supplier documentation and Scilife's CSV package. This provided a strong validation foundation while allowing the team to focus its efforts on intended use, configuration, risk assessment, and process-specific testing.
The result was a risk-based validation approach that significantly reduced internal effort while maintaining ownership of the validated state.
The release notes accompanying each update delivered another advantage. Instead of re-testing the entire platform after every change, the team could quickly determine whether an update affected validated processes, saving valuable time.
For a lean quality organization, that translated into faster validation with no compromise on compliance.
Scalability became one of the most important business drivers behind the project.
As the company expanded, the number of employees, SOPs, policies, training requirements, and quality records continued to increase.
Managing that growth through paper records and spreadsheets was no longer realistic.
Today, GMP procedures, research documentation, safety records, corporate policies, and training activities are managed within a single system.
The quality team no longer has to maintain separate tracking tools or manually reconcile records across multiple locations.
“We are a growing company, and with a paper-based system that growth simply wasn’t scalable anymore. We needed a system like Scilife."
Bodo Brocks, Head of Quality, Coriolis
Of all implemented processes, training management delivered the most immediate impact.
Previously, every SOP revision required training sessions, paper records, signatures, manual follow-up, and spreadsheet updates. Coordinating training across the organization often required multiple sessions and significant administrative effort.
Today, training assignments are automatically triggered when document revisions become effective. Documents, training records, and employee status are linked within a single system, providing real-time visibility into completion status and outstanding actions.
“Now, for a new SOP version, training is automatically triggered by Scilife. Everything is linked, and it makes life much easier."
Susanne Gärths, Quality Manager, QA, Coriolis
What previously required extensive coordination now happens automatically.
The move to a digital quality system has also simplified audit preparation.
Instead of searching through paper files, scanned records, and spreadsheet trackers, the quality team can access documents, approvals, training records, and audit trails directly within the system.
Auditors have responded particularly well to the automated relationship between document revisions and training assignments.
“The auditors highlighted that they liked the link between training and documents: when an SOP is updated, the training is triggered automatically. Also, I cannot remember any training-related findings since we had Scilife.”
Susanne Gärths, Quality Manager, QA, Coriolis
The result is greater confidence during inspections and faster access to evidence when auditors request information.
Successful implementation depended on more than technology.
Quality, IT, and data science teams were involved throughout the evaluation, selection, risk assessment, and implementation process. This collaborative approach helped build organizational confidence and strong user adoption from day one.
Following go-live, feedback from employees was overwhelmingly positive.
“We communicated it upfront before we went live to the complete company. We had kickoff meetings and onboarding trainings. We received lots of positive feedback. People felt it was better than the paper-based system.”
Susanne Gärths, Quality Manager, QA, Coriolis
The impact of Scilife extended beyond efficiency gains.
By eliminating repetitive administrative work, the quality team gained time to focus on higher-value activities.
That time is now spent on continuous improvement initiatives, supporting client projects, and implementing additional quality processes across the organization.
The team also described a less measurable but equally important benefit.
Instead of spending time printing, stamping, scanning, filing, and manually updating spreadsheets, quality professionals can focus on work that improves compliance, supports growth, and delivers value to the business.
For highly skilled quality professionals, that shift matters.
When asked what advice they would give to other quality leaders still relying on paper systems, spreadsheets, or internally developed tools, the Coriolis team was clear:
“Implement an off-the-shelf system and don't spend time configuring every internal process around it. Adapt your workflows where needed and benefit from what's already there.”
Bodo Brocks, Head of Quality, Coriolis
For Coriolis, the transition was never just about digitization.
It was about creating a scalable quality foundation that supports growth, simplifies compliance, reduces validation burden, improves audit readiness, and allows quality professionals to focus on continuous improvement instead of paperwork.
Coriolis' journey shows how growing German life sciences companies can move beyond paper, spreadsheets, and manual processes without taking on the complexity of enterprise-scale systems.
By implementing Scilife, Coriolis created a scalable, audit-ready quality foundation that reduced administrative burden, simplified validation, and gave the quality team more time to focus on continuous improvement and growth.
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