TCT Portal Reviews

Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness. Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards. Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams. Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations. The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.

Compliance work eats engineering time. Hyperproof exists to give that time back by automating the parts of GRC that don't need a human: pulling evidence out of GitHub, Jira, ServiceNow, Snyk, and cloud storage on a schedule, running recurring tests against high-frequency controls, and kicking off a task automatically the moment something fails instead of waiting for the next audit cycle to find out. Under the hood, Hyperproof maps one control to 160+ frameworks (SOC 2, ISO 27001, HIPAA, NIST, and others), so a control tested once can satisfy several standards instead of forcing teams to rebuild the same work per framework. AI agents handle the first pass on evidence review and gap-flagging, leaving humans to make the actual judgment calls rather than hunting down documentation. Teams using it report cutting audit prep by roughly 350 hours a year, a 66% drop in duplicate controls, and about $150K saved annually on control orchestration. It also scales to messier org charts, with the ability to scope controls by business unit or entity instead of flattening everything into one program. Built in 2018 out of the Seattle area, Hyperproof is used by engineering and security-heavy orgs like Reddit, Fortinet, Appian, and Outreach that are tired of treating compliance as a manual, spreadsheet-and-email process and want it to run more like the rest of their infrastructure: automated, monitored, and auditable.