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For White Raven, this number is more than a simple milestone, serving as proof of a deliberate, engineered strategy.
Achieving GMP certification in 18 months, which is roughly 66% faster than typical pharmaceutical timelines, is extraordinary under any circumstances. For a startup building facilities, cleanrooms, qualification systems, ERP infrastructure, computer system validation (CSV), and a full quality management system simultaneously, all from scratch, it required more than hard work. It required very meticulous design.
Adam Soufi, Marketing Director, and Johan Lambersens, CTO & co-founder, spoke with Fabiola Samueli, Customer Success Manager at Scilife to tell us how from day one, White Raven designed its entire organization around a single objective: inspection readiness, without compromise.
A strategy that ultimately enabled GMP certification in just 18 months.
White Raven is a Belgian CDMO specializing in small-batch fill-and-finish services for injectable products. They primarily support biotech companies, and occasionally larger pharma organizations, that need flexible, high-quality manufacturing capacity for clinical and early commercial supply.
Purpose-built for smaller volumes that traditional CDMOs often deprioritize, White Raven invested in a fully robotic, gloveless isolator fill/finish line designed for sterility, rapid changeovers, and reduced cross-contamination risk.
That same philosophy based on precision, risk management, and smart engineering, guided their quality strategy.
As stated above, White Raven wasn’t just optimizing their operations. They were starting from scratch: building facilities and cleanrooms, establishing supplier networks, implementing ERP systems, qualifying equipment, developing CSV documentation, and deploying a fully GMP-compliant QMS.
The complexity was volume, as much as interdependence: a delay in documentation affects validation. A delay in validation affects inspection readiness. A delay in inspection readiness delays manufacturing authorization.
To compress timelines safely, the team needed a structured yet pragmatic approach. They defined a clear roadmap covering both production readiness and GMP inspection preparation from the outset.
A critical early decision was to implement an eQMS from the outset.
When asked how they achieved certification so quickly, the answer wasn’t one tool or shortcut. It was a coordinated strategy built on four reinforcing pillars:
1. Lean and agile execution
Construction, qualification, SOP development, and inspection preparation progressed in parallel. SOPs were prioritized based on operational risk, ensuring GMP-critical processes were in place early.
2. Cutting-edge technologies designed for control
From robotic, gloveless isolators to digital batch traceability, White Raven invested in systems that reduce contamination risk and strengthen compliance.
3. Embedded quality risk management
Risk assessments guided decisions across contamination control, validation scope, and supplier qualification. High-risk areas received deeper validation and oversight. Data integrity principles such as ALCOA+ were embedded across systems.
4. Strategic partnerships
Vendors and technology partners were selected based not only on functionality, but on their ability to support GMP-readiness, documentation robustness, and validation efficiency.
This coordinated model allowed White Raven to remove friction without increasing regulatory exposure.
The result: GMP certification in 18 months, approximately 66% faster than typical industry timelines. And importantly:
“This approach does not reduce the quality at all. We did not increase the risk. The overall quality is very high."
Johan Lambersens, CTO & co-founder
If GMP certification was the destination, the quality management system was the engine.
From the start, White Raven knew their QMS would be one of only two core systems in their organization, alongside their ERP. It had to do more than store documents, also supporting inspection readiness, streamline validation, and scale with growth.
When evaluating solutions, the team was looking for a partner capable of supporting their accelerated GMP roadmap.
That’s where Scilife entered the picture.
As a digital-first CDMO, White Raven knew their QMS would be one of the two core systems in their stack, alongside their ERP. However, many traditional eQMS providers felt outdated and misaligned with their strategy. Legacy systems often operated as “black boxes,” limiting integration, automation, and long-term scalability.
For a company built on agility, that was a deal-breaker. White Raven wanted fully digital workflows from project initiation to batch release, eliminating administrative friction so teams could focus on quality-driven decision-making.
Standardization was prioritized over heavy customization. Scalability was designed in from the beginning.
A modern, web-based platform was essential. They needed it to be accessible from anywhere, without software installation. But the real differentiator was API integration.
API access was non-negotiable. With Scilife, they found a platform that set a foundation enabling automation and AI initiatives, like connecting chatbots to their QMS to quickly retrieve information and answer questions, which would not have been possible with a traditional closed system.
Implementation moved quickly. As a new company, there was no legacy QMS to migrate and no entrenched processes to untangle.
From the outset, they built their quality system around GMP requirements, rolling out core modules early:
This phased approach ensured GMP-critical processes were defined, validated, and operational well before inspection, creating a strong compliance foundation that made White Raven’s QMS inspection-ready sooner.
The most time-consuming element was computer system validation (CSV), which in the pharmaceutical industry often represents the heaviest lift in any software deployment. Scilife’s pre-validated packages and structured validation approach significantly reduced the effort required.
“I think the main challenge we faced was computer system validation. In pharma, CSV is really the most time-consuming part of software implementation, so Scilife’s pre-validated packages were a big help in reducing that effort.”
Johan Lambersens, CTO & co-founder
Adoption, however, was seamless. Teams coming from older systems found Scilife intuitive, easy to access, and easy to search.
White Raven also intentionally avoided heavy customization.
“We didn’t want to rely on customization services. We wanted maybe an 80–90% standard quality management system and customize the remaining 10% ourselves.”
Johan Lambersens, CTO & co-founder
For Johan and the operational team, certain features make a tangible difference.
Word integration is one of the most appreciated capabilities across the organization. Because employees already use Word, drafting and reviewing documents feels natural and frictionless.
The “My items” dashboard is central to Johan’s daily routine, serving as a consolidated view of pending reviews and tasks across modules.
“The dashboard is really where I go first to check if I’m late for something or if I’m due to do some actions.”
Johan Lambersens, CTO & co-founder
Finally, the audit trail provides essential traceability in a regulated environment, making it easy to understand what happened, who performed each action, and how processes evolved over time.
For Adam, Scilife supports White Raven’s broader positioning. Achieving GMP certification in a short timeframe became a powerful story to communicate externally and reinforced their image as a fast, technology-driven CDMO.
He also sees strong value in the pre-validated templates. Particularly for SOP management, these prevent teams from starting from scratch and allow them to configure what’s needed efficiently.
“With the pre-validated, ready-to-use SOP templates we don’t need to start from scratch, we just need to configure some stuff and go.”
Adam Soufi, Marketing Director
Usability also stands out. The platform feels self-explanatory, reducing training needs and making adoption smoother across departments.
When asked what advice he would give to companies building their quality systems from scratch, Johan emphasized simplicity and strong foundations.
“We really don’t want to clutter our IT infrastructure with a lot of different tools. We have the eQMS on one hand, and the ERP on the other. These are the two main systems that we maintain.”
Johan Lambersens, CTO & co-founder
For Johan, adding too many disconnected systems only creates inefficiencies, integration headaches, and unnecessary risk. Instead, he recommends building around a small number of robust core platforms and designing everything else around them.
He also advocates for standardization over customization. Keeping the system mostly standard simplifies validation and ensures scalability.
Avoiding closed systems also remains critical.
“A lot of actors are acting as a closed box that we cannot interact with programmatically. Which is painful for us because we want to automate and integrate our solutions.”
Johan Lambersens, CTO & co-founder
Training, he adds, should focus on quality processes instead of software clicks. As Johan Lambersens, CTO & co-founder, explained, “The UI is quite self-explanatory, and our trainings are about the process, not about what button I should click.”
Just as importantly, speed did not mean sacrificing quality. Lambersens also noted, “This approach does not reduce the quality at all. Not only did we not increase the risk, but the overall quality is very high.” Together with Scilife, White Raven built a robust, inspection-ready quality system that enabled accelerated GMP certification without compromising standards.
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