Written by
Tim Westover
Co-Founder
A New Era of Connected, Compliant Laboratory Management
Introduction
For nearly three decades, laboratories have trusted MediaLab by Vastian to power their compliance, training, and inspection readiness. Now, that legacy expands with the introduction of Operis — a groundbreaking hub for connected and compliant laboratory operations.
After years of development and collaboration with pilot sites, Operis represents the next evolution of laboratory quality management — bridging the operational silos that have long challenged lab leaders.
Dozens of labs joined together live to explore a new way to manage quality, compliance, and operations in a single, unified system — and the discussion that followed was every bit as groundbreaking as the technology itself.
If you missed our live sessions, here’s your inside look at what had laboratory leaders buzzing — and the questions they were asking.
“We built Operis because laboratories already have repeatable, auditable processes.
They just need a system that connects them.”
— Tim Westover, MediaLab by Vastian
Why Laboratories Needed Operis
Across the industry, laboratories rely on dozens of disjointed tools — spreadsheets, shared drives, binders, ERPs, and vendor portals — to manage day-to-day operations.
Each one holds a piece of the puzzle: suppliers, test menus, instruments, reagents, audits, and PT tracking. But these fragmented systems lack one crucial thing: a quality lens.
ERP systems like NetSuite or hospital vendor portals may capture purchase orders, but not what matters most to labs:
- Has this vendor ever required a corrective action?
- Have they ever been late?
- Has a product issue led to a non-conforming event or complaint?
- What’s the lab’s risk assessment for this supplier?
Without a single source of truth, labs spend valuable time searching across systems, logins, and shared folders — especially when inspectors arrive. Operis changes that.
“Every workflow you showed — equipment, PT, supplier reviews, etc. — it all looked like what we do now or need to do. Only faster, cleaner, and finally connected.” – Lab Manager, Academic Medical Center
That sentiment was echoed throughout the live demo, as lab leaders saw familiar processes presented in a completely unified system for the first time.
The Foundation of Operis: Repeatable Processes, Unified
Laboratory functions — from supplier qualification to PT tracking — involve repeatable processes that demand documentation, accountability, and traceability.
Operis brings them all into one integrated, intelligent platform.
Each module includes built-in, expert-designed forms aligned with common laboratory workflows, giving every client a strong starting point they can tailor to their exact process.
Suppliers & Vendors
- Qualify, review, and monitor vendor performance
- Track supplier corrective actions (SCARs)
- Link supplier data to non-conforming events and complaints
Test Menus & Analytes
- Manage new test requests, research documentation, and utilization
- Maintain calibration verification and discontinuation workflows
- Link each test to related equipment, reagents, and vendors
Instruments & Equipment
- Schedule and document maintenance, QC, and service events
- Store service contracts and vendor records for every instrument
- Monitor recurring work orders and preventive actions
Facilities & Audits
- Manage internal audits, safety rounds, ergonomics checks, and environmental inspections
- Assign responsibilities by department or location
- Track findings, corrective actions, and follow-ups
Proficiency Testing (PT)
- Schedule PT events and assign staff
- Track reporting and investigations for unsatisfactory results
- Link PT failures to CAPA workflows through integration with IQE
How Operis Works With — and Without — IQE
Operis is a standalone application that can be purchased and used independently.
You do not need IQE to implement Operis.
While both platforms are part of Vastian’s connected laboratory ecosystem, they serve distinct — and complementary — purposes. IQE focuses on event and investigation management, while Operis is dedicated to managing the ongoing operational processes that keep the lab inspection-ready every day. Operis functions independently as a connected laboratory operations layer. For laboratories that also use IQE, the two applications can share information seamlessly—but each delivers full value on its own.
Common Client Questions, Answered
Q: Are the forms already built into Operis?
A: Yes. Operis comes preloaded with expert-designed forms covering the core operational areas — from equipment maintenance and supplier qualification to PT tracking and facility audits. Each is fully customizable, but you start with a proven, compliant foundation so your team can go live faster without building from scratch.
Q: Can we upload multiple instruments at once?
A: Yes. You can import via CSV, defining fields like serial number, make, model, and nickname — saving hours of manual entry.
Q: Is editing or adding steps similar to IQE?
A: Yes. The form editor in Operis mirrors IQE’s flexibility, allowing you to add steps, update workflows, or adjust fields as needed. Each core workflow — such as equipment, PT, and supplier management — already comes with prebuilt forms developed by our quality experts, giving you a strong head start before you customize anything.
Q: Can we view compliance levels or progress in dashboards?
A: Yes. Monthly dashboards show completion rates and trends — similar to IQE analytics but focused on operational compliance.
Q: What about alternative performance assessments?
A: Operis allows you to build and schedule alternative assessments, then link them to PT events and your test menu for complete traceability.
Q: If a CAPA is initiated due to a PT failure, does it connect to IQE?
A: Absolutely. Operis can launch or link directly to IQE CAPA workflows so all corrective actions are managed through your existing IQE structure.
Q: Do we need IQE to use Operis?
A: No. Operis is a standalone application that can be implemented independently. It delivers full operational functionality without requiring IQE, though integration with IQE adds traceability between operational activities and NCEs, CAPAs, and the ability to utilize IQE forms you’ve established as part of Operis workflows.
Q: Can we use existing IQE forms for instruments or audits?
A: Yes. You don’t need to rebuild your forms. Operis can reference existing IQE forms, maintaining your current event log structure.
Q: Can we upload historical data or scanned records?
A: Historical paper logs, maintenance records, or spreadsheets can be uploaded for digital archiving within Operis, keeping legacy data accessible.
Q: Is there linking between test menus and personnel?
A: Yes. Operis integrates with the Personnel Documentation module, allowing you to link staff rosters or competency records to specific tests.
From Spreadsheets to Smart Systems
Unlike legacy systems that take months to deploy, Operis is designed for simplicity.
Labs can import their existing spreadsheets — vendors, test menus, equipment lists — directly into Operis, transforming disconnected data into dynamic, relational lists.
Once imported, Operis automatically connects these lists:
- Instruments link to vendors and service contracts
- Tests link to instruments, analytes, and reagents
- PT kits link to test menus
- Facilities link to departments and audits
This intelligent connectivity provides a unified view of operations and quality in real time.
Built for the Day of Inspection — and Every Day Before It
The last thing any laboratory wants is to scramble the week before an inspection, tracking down maintenance logs, vendor files, or PT documentation.
With Operis, everything is organized, searchable, and inspection-ready.
As Westover said:
“By having it all in one system, you are inspection-ready at a moment’s notice.”