UL Introduces an Affordable Regulatory Approval Solution for SMBs

Avoidable audit findings sideline too many small and mid-size businesses (SMB) in the life sciences. As a result, critical product regulatory approvals can be jeopardized or delayed due to inconsistent or inadequate training activities and incomplete or error-ridden reporting.

These same types of companies shared with me that they bypassed the addition of a learning management system (LMS) because of two key reasons:

  • “We don’t have the budget for an enterprise system.”
  • “We don’t have the staff to implement and manage an LMS.”

As a result, their manual documentation left them vulnerable to easily preventable audit findings.

So, we got to work creating a solution to bypass both barriers.

Our PURE® Learning team created ComplianceWire® for SMB specifically designed to meet the unique needs of emerging SMB companies.

For the first time, SMBs in regulated industries now have access to UL’s ComplianceWire® LMS, the same learning management system used by the largest pharmaceutical, healthcare, medical device and regulatory agencies in the world — including the FDA — but without the cost and complexity.

ComplianceWire® facts

  • 500 million training records
  • 50 million annual training completions worldwide
  • 10 million trained and compliant users
  • 21 CFR Part 11 Compliant

SMBs can access the same LMS used by the FDA

For 20 consecutive years, the FDA has used ComplianceWire® and UL’s eLearning content to maximize investigator quality and compliance under a unique Cooperative Research and Development Agreement (CRADA).

Within approximately 60 days, your training program can be automated via ComplianceWire® for SMB, the same LMS technology trusted by the FDA to train more than 36,000 global, federal, state and local investigators.

ComplianceWire® assets

On an easy per user pricing model, our ComplianceWire® for SMB delivers:

  • Client-ready validation package – Expedite your validation of the solution with all the necessary templates and documentation.
  • Best practices workshop – Take a one-day workshop, hosted by our training experts, to tune the training solution to your unique needs.
  • Rapid deployment – Automate and standardize your training on ComplianceWire in under 60 days.
  • Regulatory content – Access to proprietary, industry-leading content, written and/or reviewed by FDA experts.

ComplianceWire® LMS for SMBs converts data from manual to digital in a few easy steps and offers a wealth of assets, including affordability.

Turnkey, scalable and affordable learning management

There is a tremendous amount of excitement and innovation emerging from small and mid-size life sciences brands today, destined to benefit us all.

But without government approval, they can’t help anyone.

UL’s ComplianceWire® for SMB supports these companies with tools to limit risk, achieve regulatory compliance, and advance these products to the marketplace faster.

Call 609.627.5300 to speak with our SMB specialists or visit http://ULEHSsustainability.com/cw-smb to learn more.