Compliant Quality Event Management with Kivo QMS

Kivo QMS streamlines quality event management by replacing manual processes with intuitive, automated workflows that align directly with your SOPs. When a deviation, nonconformance, or complaint is logged, the system intelligently routes it through the appropriate workflow, whether that involves a risk evaluation, root cause analysis, or CAPA initiation. Templates are fully configurable, so your team isn’t forced into rigid structures. Instead, you define how events should be handled based on your internal procedures, and Kivo enforces those rules automatically.

Beyond workflow automation, Kivo offers real-time reporting dashboards and audit-ready records that make it easy to monitor open events, identify bottlenecks, and prepare for inspections. Every action is traceable with time-stamped audit trails, linked documentation, and controlled user access. Because it all runs on Kivo’s unified platform, you eliminate the silos between event management, training, change control, and document control, which means fewer version conflicts, faster resolutions, and a more proactive quality system.

Quality event software helps life sciences companies meet FDA and ISO compliance requirements by enforcing standardized workflows and preserving a full audit trail. This includes time-stamped records of actions, electronic signatures, version control, and secure document storage. For FDA compliance (like 21 CFR Part 11), systems must also demonstrate controls for electronic records and signatures, while ISO 9001 or ISO 13485 require traceability and effective handling of nonconformances.

Instead of relying on spreadsheets or siloed tools, quality event software ensures that every incident is recorded, categorized, and addressed according to a validated process. This consistency is critical for inspection readiness and for reducing compliance risk across your manufacturing, clinical, or quality operations.

Yes, Kivo QMS is fully designed to meet the stringent compliance requirements of life sciences organizations. It adheres to 21 CFR Part 11 standards for electronic records and electronic signatures, providing features like audit trails, version control, and secure user authentication. This ensures that every action taken within the system is traceable and attributable, a core requirement for FDA inspections and GxP environments. Additionally, Kivo supports configurable workflows that enforce SOP-driven processes, helping you maintain consistency across events like deviations, CAPAs, and complaints.

Beyond functional compliance, Kivo also meets the highest standards for data security. The platform is SOC 2 Type II certified, which means its controls for data privacy, availability, and processing integrity are independently audited and validated. All customer data is encrypted in transit and at rest, and the system is hosted in secure, compliant cloud environments with disaster recovery and uptime guarantees. Whether you’re undergoing a routine audit or a regulatory inspection, Kivo ensures your quality system is always inspection-ready. You can explore technical details and documentation in our trust center.

Kivo QMS was designed specifically for the needs of modern, decentralized life sciences teams, where collaboration happens across sites, time zones, and functions. That means it works well right out of the box, with intuitive workflows and compliance-ready templates that help teams get up and running quickly. But just as important, it’s also built to adapt. Every organization’s quality system is different, and Kivo gives you the tools to configure the platform to match your unique SOPs, terminology, and approval processes.

You can customize workflows, templates, fields, roles, and escalation rules to reflect how your team already operates. Whether you need to manage deviations, complaints, CAPAs, or change controls, Kivo allows you to structure each process in a way that aligns with your internal requirements while staying fully compliant. This flexibility ensures that your quality system supports real-world operations, not just regulatory checkboxes.

Kivo QMS is built to manage a comprehensive range of quality events across the product lifecycle, from early development through commercial manufacturing. It supports structured workflows for deviations, non-conformances, and complaints, ensuring each event is properly logged, investigated, and closed with full traceability. These events can be initiated manually or triggered automatically based on related system activity, such as a failed inspection or batch discrepancy.

Beyond core event types, Kivo also supports CAPA management, risk evaluations, and change control processes, all within the same connected system. For example, a deviation can be linked directly to a risk assessment and escalate into a CAPA if needed, with all records and documents tied together for streamlined audits. You can configure each event type to follow your SOPs, with built-in routing, approvals, and documentation requirements that ensure compliance without the need for workarounds or duplicate data entry. Whether you're tracking a product complaint from the field or managing a supplier issue, Kivo provides a unified, inspection-ready environment for end-to-end quality management.

Yes, the market has evolved to support the needs of smaller or growing life sciences companies with right-sized, affordable solutions. While legacy systems like MasterControl may be out of reach for startups, platforms like Kivo were designed specifically to bring enterprise-grade compliance within reach of teams with limited resources.

Kivo offers pre-validated templates, faster implementation timelines, and pricing that scales with your team size. For early-stage companies, this means you can stop relying on error-prone spreadsheets and move to a compliant system without breaking your budget. The long-term ROI comes not only from avoiding audit findings, but from building quality infrastructure that grows with you.