921Docs 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.

Polonious is an ISO27001 investigation management workflow solution designed around 3 key principles: 1 - Security 2 - Process centric 3 - Configuration and flexibility What this means is that Polonious allows you to build workflows to manage your investigations in a way that manages your data and your evidence in a highly secure, ISO27001 certified way; allows you to comply with any regulatory requirements with minimal headache and effort by building workflows which are inherently compliant, and; does so without the need for expensive and time consuming code changes - it's even possible for users to do it themselves via the GUI. With Polonious, you can run detailed reports on case outcomes, timeframes, and finances, and break that down across case types, investigators, and even down to investigation status. So you can prove your value up the chain, but you can also identify any problem areas and improve your efficiency.