Next-Generation Sequencing Company Uses SIMCO Automated Software Validation to Accelerate Market Readiness
Overview:
A life sciences innovator specializing in next-generation sequencing (NGS) technologies was poised for a major market transition. After operating in the research-use-only (RUO) space for years, the company set its sights on the more highly regulated in vitro diagnostics (IVD) market—a shift that would bring stricter FDA oversight, higher quality expectations, and increased compliance requirements.
This transition was also a commercial necessity. While RUO products are limited to academic or scientific labs, IVD products open the door to large diagnostic laboratories and hospitals. Meeting the demands of FDA compliance and scaling operations in the U.S. diagnostic market meant implementing a new quality management and product lifecycle management system (EQMS/PLM). But validating the software, without overwhelming a lean quality team, posed a formidable challenge. That’s where SIMCO’s Automated Software Validation solution proved critical.
The Challenge:
Transitioning to FDA-Regulated Markets with Limited Resources
Entering the IVD space required new systems and a clear demonstration to the FDA that those systems met compliance requirements. Compounding the issue, the company was already in the midst of rapid transformation due to its recent acquisition.
The company implemented Arena, a cloud-based eQMS/PLM platform, and its quality team quickly faced a critical resource bottleneck. Validating this system using traditional paper-based methods required significant time and personnel resources that the company didn’t have, with a team consisting of two new hires and an external consultant.
“With a manual validation process, these protocols required weeks of work, pulling skilled team members away from higher-value and strategic work, better aligned with their expertise,” said the Quality Consultant. And this time could potentially double or triple, as any deviation could require significant rework in the manual execution.
The Solution: SIMCO Automated Software Validation
The company replaced manual execution with SIMCO’s Automated Software Validation, gaining immediate time savings, enhanced traceability, and reduced compliance risk. SIMCO’s team executed three PQ protocols for the Arena system, delivering validation reports and full audit-ready evidence, including auto-generated screenshots and an end-to-end video recording, which was a critical differentiator.
“It felt like magic. We handed over the protocol, and got back everything—screenshots, a video, and a full report—and all without using internal bandwidth,” the Quality Consultant added. The shift preserved quality resources for more strategic tasks, like FDA readiness, improving customer satisfaction, and supporting product development.
Arena pushes 3-4 updates per year, and the company plans to complete additional protocol validations using SIMCO’s scalable, automation-based model for future revalidations. They’ll be executed in record time, without draining internal resources or compromising compliance.
Why Video Matters
Most validation systems offer screenshots, but SIMCO provides full video evidence of test execution. That’s a critical edge for audit prep and traceability. “The video gives us confidence that if the FDA or internal teams ever ask for evidence, we can show exactly what was executed and how.”
A Trusted Partner
The decision to work with SIMCO was rooted in familiarity and trust. The company’s Director of Quality had previously worked with SIMCO for software, calibration, and maintenance services and felt confident in its reputation for reliability and regulatory alignment.
“We already knew SIMCO as a solid, trusted supplier. When we saw that they offered Automated Software Validation, it was a no-brainer,” the Quality Consultant shared.
Activating Resources Where They Matter Most
“Software validation is critical, but it redirects team expertise away from the quality work that truly impacts our customers, like ensuring product performance and supporting compliance. SIMCO helps us streamline validation so our team can stay focused on what matters most.”
Benefits Delivered
- 90%+ Reduction in Validation Test Execution Time
- Manual execution: Time commitment reduced from weeks to hours
- SIMCO-automated execution: < 1 hour of review
- Audit Readiness, with Full Traceability
- Automated screenshots and execution video
- Files align with FDA requirements and are inspection-ready
- Ideal for recurring system updates (up to 4 times per year)
- Reduced Error & CAPA Risk
- Automation ensures consistent execution and complete evidence
- Reduced chances of deviation, missed screenshots, or rework
- Avoids deviations that could trigger CAPAs or nonconformances during inspections
- Expert Talent Realigned to High-Value Work
- Frees up quality staff to work on strategic initiatives, customer complaints, regulatory filings, and product quality
- Opportunity cost avoided—no more tying up experts on redundant documentation tasks
- Confidential & Secure
- SIMCO does not own your data; you do. SIMCO ensures that your data is safe, secure, and available
A Strategic Fit for Evolving Life Sciences Companies
While SIMCO’s solution delivered strong results for a mid-sized client, its value scales across the life sciences sector:
- Startups can move quickly without building internal validation expertise.
- Growing companies gain compliant, risk-based validation without the drag of manual processes.
- And large enterprises save months of time, while maintaining validation integrity across complex, multi-site systems.
- “Even if you have a larger team, your quality staff should be working on customer satisfaction and product quality, not slogging through redundant software validations.”
Even Large Teams Can’t Afford Delays
For large organizations, validation delays stall projects, sideline people, systems, and impact ROI. SIMCO helps enterprise teams move faster by eliminating bottlenecks, reducing compliance risk, and getting critical systems into use without delay.
About SIMCO’s Automated Software Validation
SIMCO’s Automated Software Validation combines powerful test execution with clear traceability and real-time audit readiness. Deliverables include:
- PQ execution of customer-provided protocols and document formats
- Auto-generated screenshots and full video
- Summary reports with deviation tracking
- Automated Software Validation Portal for secure data exchange
- Seamless support for Arena updates or other EQMS/PLM platforms
Whether you’re scaling up or managing multi-site compliance programs, SIMCO helps quality teams stay compliant, efficient, and customer-focused.