Quality management built for the multi-client complexity of contract manufacturing

FAQ Questions & Answers

Q: Is Kintavo designed for CDMO quality management? Kintavo is built for the specific complexity of contract development and manufacturing organizations — multiple sponsors, multiple products, and multiple regulatory frameworks running simultaneously under one quality infrastructure. Document Control supports master SOPs alongside client-specific quality manuals and tech-transfer packages with sponsor-isolated access controls. Deviation and change-control workflows can be configured per-sponsor while sharing the same platform infrastructure. Cross-sponsor trending and operational metrics are aggregated for internal quality leadership without exposing one sponsor's data to another.

Q: How does Kintavo handle sponsor data isolation? Every sponsor program in Kintavo operates in a tenant-isolated environment — documents, deviations, CAPAs, training records, batch QC data, and change records are partitioned by program and accessible only to users with the appropriate sponsor-specific permissions. When a sponsor's quality team or auditor logs in, they see only their program's records. CDMO operations leadership can view aggregated metrics across all programs through a consolidated dashboard without any cross-sponsor data exposure. SOC 2 controls govern the security and availability of sponsor data at the platform level.

Q: How does Kintavo handle tech transfer programs? Technology transfer in Kintavo is managed as a structured document and process lifecycle rather than an ad-hoc project. The receiving site accesses the tech-transfer package — process documents, equipment qualification records, analytical method validations, and training curricula — through a controlled handoff workflow with documented review and approval at each stage. Changes during the transfer period route through formal change control with sponsor-aware impact assessment. When the transfer closes, the process knowledge lives in the same system as the ongoing GMP quality records, not in a separate folder that becomes stale the moment manufacturing begins.

Q: How does change control work across multiple sponsor programs? Kintavo's Change Control module supports sponsor-scoped change workflows — each program can have its own change categories, impact assessment templates, approval routing, and notification requirements. When a site-wide change affects multiple sponsor programs simultaneously — a shared equipment change, a raw material supplier switch, or a facility modification — the change record identifies all affected programs and routes sponsor-specific notifications and approval requests accordingly. Operations leadership can view the full cross-program impact of any site change. Each sponsor sees only the impact on their program.

Q: How does Kintavo support quality agreement management between CDMOs and sponsors? Quality agreements between the CDMO and each sponsor define the division of GMP responsibilities, escalation paths, deviation notification timelines, and change approval requirements. In Kintavo, those quality agreement obligations are operationalized as workflow configurations — the system enforces the notification timelines, routes escalations to the agreed contacts, and applies the sponsor-specific deviation categories and change classification criteria that the quality agreement specifies. When a sponsor auditor reviews your quality system, the workflows they see reflect the quality agreement they signed.

Q: How does Kintavo support sponsor audits at CDMO facilities? When a sponsor's quality team schedules an audit, Kintavo's Audit Management module organizes the audit scope, checklist, observation capture, and CAPA integration — scoped to that sponsor's program data. The pre-audit report pulls current evidence from the sponsor's isolated records: SOP currency, training completion rates, open deviations and CAPAs, change control backlog, equipment qualification status, and supplier qualification records relevant to the sponsor's materials. The sponsor's auditor sees a quality system that reflects their program, not a generic view of the CDMO's entire quality record.

Q: How does Kintavo handle shared equipment used across multiple sponsor programs? Shared manufacturing equipment in Kintavo has a single asset record — qualification history, calibration schedule, preventive maintenance log, cleaning validation — that serves all programs using it. When a deviation or equipment failure occurs, the impact assessment identifies every active sponsor program that uses the affected asset and routes program-specific notifications per each sponsor's quality agreement requirements. Cleaning validation records and campaign change notifications stay organized by program while sharing the underlying equipment history. Operations sees the full asset utilization picture; each sponsor sees only what's relevant to their program.

Q: How does Kintavo support regulatory inspections at CDMO facilities? FDA, EMA, PMDA, and other regulatory inspections at CDMO facilities review the site's GMP compliance as it applies to all licensed operations. Kintavo's Audit Intelligence™ monitors the site's quality posture across all programs simultaneously — surfacing overdue items, training gaps, open deviations, and calibration lapses that an inspector would find regardless of which sponsor's product is under review. Pre-inspection reports pull current site-wide evidence. During an inspection, any record for any program is retrievable in seconds. If the inspector focuses on a specific sponsor's product, the program-scoped records are immediately accessible without filtering through unrelated data.

Q: How does training management work for CDMO staff working across multiple sponsor programs? Staff at CDMOs often work across multiple sponsor programs — each with its own SOPs, process-specific requirements, and training curricula. In Kintavo, training assignments are role-based and program-aware. When a technician is assigned to a new sponsor program, the relevant training curriculum assigns automatically. When a sponsor's SOP is revised, the training assignment routes only to the staff members assigned to that program. Competency records are maintained per staff member across all programs they're qualified for. When a sponsor auditor asks for training records for the technicians who ran their batches, the program-scoped training history is retrievable immediately.

Q: Can Kintavo scale as a CDMO adds new sponsor programs? Yes. Adding a new sponsor program to Kintavo is a configuration activity, not an implementation project. The new program inherits the site's master SOP library and equipment records as a starting point, with sponsor-specific customizations applied through the Workflow Builder without IT involvement. New program setup — document library, training curricula, deviation categories, change control configuration, supplier qualification requirements, and quality agreement workflow mappings — typically completes within days. Each new program added shares the same platform infrastructure, so the quality team's operational overhead grows linearly with the program portfolio rather than multiplying with each new sponsor.

Q: What does implementation look like for a CDMO? Your implementation lead works with your quality leadership to configure the site's master SOP library, shared equipment records, deviation categories, CAPA workflows, change control gating, training curricula, and regulatory framework mappings — along with the initial sponsor program configurations — typically within the first two to three weeks of onboarding. Kintavo provides IQ/OQ documentation to support GxP computerized system validation. Existing SOPs, open quality records, and equipment records can be migrated from spreadsheets or prior systems. Most CDMOs are processing live quality events in Kintavo within 30 days of kickoff.