Qualio has officially announced the launch of Compliance Intelligence, which happens to be a major new capability available inside the Qualio Platform.
According to certain reports, this particular solution arrives bearing an ability to unify regulatory compliance, quality management, and product lifecycle into one auditable system, all for the purpose of helping teams stay continuously audit-ready with less effort.
Complementing that would be a facility for intelligent data-to-requirement mapping and gap detection, cross framework monitoring, real-time compliance dashboard, built-in collaboration, and support for custom frameworks alongside FDA QMSR, ISO 13485, ISO 9001, ISO 27001 and MDSAP.
To understand the significance of such a development, we must take into account how regulatory expectations are currently shooting through the roof. You see, during FY2024 alone, FDA issued 47 medical device warning letters, with 27 tied to Quality System Regulation requirements, thus suggesting that quality and compliance remain under close scrutiny.
In case that wasn’t enough, a separate line of independent industry estimates also claim that recall costs may reach between $10 and $100M for pharmaceuticals. Some warranty or recall processes can even reach $600M when all impacts are considered.
Against that, Qualio Platform brings forth a setup capable of centralizing requirements, evidence, and actions across quality, regulatory and R&D functions. Alongside that, we have comprehensive compliance intelligence which facilitates transition from point-in-time, document-centric, reactive compliance practices to data-centric, realtime audit-readiness.
Then, there platform’s always-on capability which focuses on monitoring the regulatory requirements mapped to the latest evidence. Furthermore, it automatically flags gaps as things change, while simultaneously giving leaders a unified dashboard to prioritize and track closure.
Such a mechanism, like you can guess, treads up a long distance to orchestrate fewer surprises, shorter audit cycles, and a stronger compliance posture for lean teams.
“With this tool, the painful, time-consuming gap analysis is gone, and because you cut the risk of audit findings, the pain afterward is gone too,” said Albert Rodriguez, former FDA cardiovascular devices leader and acting deputy director.
Talk about the whole value proposition on a slightly deeper level, we begin from AI-powered gap analysis, a feature which scans your entire QMS and connected data sources, maps evidence to regulatory requirements, and at the same time, identifies gaps in minutes, not weeks.
Next up, there is a facility in place for continuous compliance monitoring with real-time alerts when changes affect your compliance status.
Another detail worth a mention is rooted in the availability of an executive dashboard, designed to deliver instant visibility into regulatory compliance & audit readiness across all frameworks.
Hold on, considering we haven’t yet touched upon guided remediation workflows that come in handy for assigning gaps, tracking progress, and maintaining audit trails.
“Compliance Intelligence gives us a 360-degree view of our audit readiness and automatically surfaces the gaps. We resolve issues faster, our team is more productive, and our risk is lower. With the system analyzing our documents and evidence end to end, we know we have full coverage and can walk into audits with confidence,” said Christophe Dohr, Site Quality Manager at Swiss medical device manufacturer Sentec.
