One System Changed Everything
How Covaris transformed a fragmented, manual quality landscape into an enterprise-wide growth engine, passing four FDA Audits in ten days and delivering over half a million dollars in productivity gains in less than 12 months.
Covaris set out to fix a broken QMS. What they built was something far more powerful: a unified quality architecture that provides effortless conformance, frees their best people for innovation, and delivered over half a million dollars in productivity gains in less than 12 months, at a fraction of the cost of enterprise alternatives.
The Covaris · Orcanos Story
Implementation Scorecards
Key metrics and outcomes from the Covaris · Orcanos implementation
A Fragmented Legacy on the Brink
Covaris had invested five years and significant resources into an eQMS platform that was failing the organization at every level. The gap between what the system promised and what it delivered had become an enterprise liability.
About Covaris
Covaris operates one of the most complex product portfolios in the life sciences instrumentation space, hundreds of sellable products, with new products entering development every month, and thousands of active parts under management at any given time. This level of complexity demands a quality system that can keep pace with continuous product evolution, not one that adds to the administrative burden.
Product Portfolio
When leadership conducted a frank assessment of their quality IT landscape, the findings were stark. Their incumbent electronic Quality Management System, built on a Salesforce-based architecture, met only 22% of Covaris' operational requirements. After five years of investment, the platform had not delivered on its promise, leaving critical gaps, referred to internally as "Red Fields," scattered across every department.
The operational workarounds that emerged to fill those gaps became structural problems in their own right. Teams relied on manual Excel spreadsheets for Bill of Materials management and calibration tracking. SharePoint drives served as informal repositories for Design History Files, CAPAs, and SCARs. Word tables carried the burden of documentation that should have lived in an integrated system. The result was an organization held together by human effort rather than intelligent architecture.
The most painful symptom was the disconnection between manufacturing work instructions and the training system. When a manufacturing document was updated, the system did not automatically trigger corresponding training requirements. This single architectural gap produced over 5,000 manual training events in 2024 alone, every one of them a risk and an avoidable cost.
Current processes are neither scalable nor sustainable for 2025 corporate growth objectives. Doing nothing means paying dearly, just to maintain the broken system, while throttling new product delivery.
Internal Strategic Assessment, CovarisDesign Requirements, Risk Management, and Non-Conformance processes remained siloed. There was no automatic linkage between customer complaints, manufacturing issues, and the CAPA process. Connecting these dots required substantial manpower and manual "intelligence", a human-powered integration layer that was both fragile and expensive.
Five years of investment in a system that met only 22% of operational needs. The verdict from Hein Smit Sibinga, Director of Quality & Regulatory, was unambiguous: the architecture had to change.
Covaris Internal Assessment · 2024System Unreliability
Limited use of existing eQMS functionality due to a poor five-year track record. Only 22% of operational requirements were being met.
Manual Workarounds
Heavy reliance on labor-intensive, error-prone Excel and SharePoint manual entry to bridge critical system gaps across every team.
Siloed Data
No automatic links between customer complaints, manufacturing issues, and CAPA processes. 5,000+ manual training events created in a single year.
Growth Throttle
The fragmented landscape was directly limiting the company's ability to reach corporate objectives and deliver on new product development programs.
Quantifying the Cost of Inaction
The "do nothing" scenario was not a neutral option. Covaris' resourcing models revealed a compounding financial drag that would have fundamentally reshaped the company's capacity for growth.
The leadership team ran the numbers with precision. Maintaining the legacy state through 2026 would have required hiring 5 additional Full-Time Equivalents across Quality, Engineering, and Manufacturing, not to grow the business, but simply to sustain a system that was already failing. The economic timeline was staged but severe:
In 2025, the burden would begin immediately: a required 1.5 FTE increase in Quality and Manufacturing support, representing $195,000 in new salary overhead. By 2026, the cumulative impact would reach its peak: $455,000 in incremental annual overhead, calculated at $130,000 per FTE, with no corresponding increase in output or capability.
Layered on top of this headcount cost was a $73,000 software renewal fee looming for the incumbent eQMS platform, a fee for a system that served only a fifth of the organization's actual needs. The math was unambiguous: the status quo had a price tag, and it was accelerating.
The "Do Nothing" Cost Model
Staying with the legacy system would have required 5 additional FTEs by 2026 at a peak incremental cost of $455K/year, plus a $73K software renewal for a platform meeting only 22% of requirements. The true cost of inaction was over half a million dollars per year, with no path to improvement.