Meet Your Deadlines with Confidence!
Nebraska-based validation experts who deliver audit-ready documentation on time, every time. Your equipment works. Your processes comply. You are audit ready!
Your Challenges are Our Speciality
- MFailed audits cost millions.
- MDelayed startups kill budgets.
- MCompliance gaps shut down production.
We eliminate these risks with validation services that work the first time.
You Deserve Partners Who Understand What’s at Stake
No sales team. No runaround. When you call BIOFLY, you talk to the engineers doing your work. Matt and Steve have 50+ years combined experience turning complex regulatory challenges into passing audits across the Midwest.
The Result? Equipment that works. Documentation that satisfies inspectors. Projects delivered on schedule.
Qualification & Validation (CQV)
Complete equipment and facility qualification including IQ/OQ/PQ protocols that ensure regulatory compliance.
Calibration Services
Cleanroom Qualification
Comprehensive calibration programs for critical measurement equipment including temperature, pressure, and environmental monitoring devices.
Clean room certification, HEPA filter testing, differential pressure analysis, and particle counting per ISO standards.
Temperature Mapping
Facility and equipment temperature validation for pharmaceutical storage, processing, and environmental monitoring requirements.
Environmental Monitoring
Continuous monitoring and validation of facility conditions including air quality, humidity, and contamination levels.
Automation & Machine Vision
Control system design, machine vision implementation, and electronic execution solutions for pharmaceutical manufacturing.
Data Integrity
FDA 21 CFR Part 11 compliance services including electronic records management and validation documentation systems.
Sterilization Validation
Steam sterilization, VHP qualification, and biological indicator processing for pharmaceutical and animal health facilities.
Process Validation
Manufacturing process review and validation to ensure consistent, compliant production that meets regulatory standards.
Our Process
01.
Contact Us
Reach out to discuss your validation needs, timeline, and regulatory requirements.
02.
Receive Your Validation Plan
We create a detailed plan covering IQ/OQ/PQ protocols, calibration schedules, and documentation requirements for your facility.
03.
Get Audit-Ready Documentation
We execute the validation work, conduct all testing and calibrations, and deliver complete documentation that satisfies regulatory inspectors.
Meet Our Team
Nebraska-based validation specialists Matt Cranford and Steve Kolb founded BIOFLY in 2015 with a simple mission: deliver validation projects that work. Our team brings over 13 decades of combined industry experience in pharmaceutical and biotechnology operations, we’ve built our reputation by delivering reliable validation solutions across the Midwest.
We understand what it takes to keep your facilities compliant, your projects on schedule, and your operations running smoothly for regulatory inspectors every time. Once a project gets going, we are right there with you every step of the way, and our final results leave you with confidence knowing your equipment and processes are within regulatory compliance.
Ready for Stress-Free Compliance?
Get the pharmaceutical expertise your operations need – from calibration to automation to regulatory validation.