--- title: "Qualio Agent: Audit Readiness on Top of Your QMS" canonical: "https://www.qualio.com/agent" updatedDate: "2026-11-05T04:00:25.000Z" description: "Qualio Agent connects to Veeva, MasterControl, Jira and more, reads your records against each clause, and puts a fix on every gap. No QMS migration." --- # Qualio Agent: Audit Readiness on Top of Your QMS Qualio Agent connects to Veeva, MasterControl, Jira and more, reads your records against each clause, and puts a fix on every gap. No QMS migration. ## Find the audit finding before your auditor does The evidence your auditor asks for lives in Jira, GitHub, Zendesk, SharePoint and your QMS. Qualio Agent reads all of it against each clause, puts a fix on every gap and checks again when a record changes. Keep the QMS you run today. ## Audit evidence lives in every system your teams use. Changes get approved in Jira and Slack. Code ships from GitHub. Complaints arrive in Zendesk. Procedures sit in the QMS, and nobody checks the rest against them until an auditor asks for a sample. ### Audit prep is a project every time Weeks of pulling evidence out of systems, collating and closing gaps distracting the company. ### The auditor finds the gap first Teams can’t verify every record; auditors can sample widely enough to find the one that missed review. ### Each standard has its own spreadsheet GxP, ISO 27001 and ISO 42001 run as separate programs, each checking the same evidence by hand. ## One assessment across every system Qualio Agent connects to the tools where the work happens, including your QMS. It maps each record to the controls of every framework you carry, scores each clause and puts a recommended fix on each gap. Guardrails ensure human-in-the-loop approvals where needed, so your team stays in control. Less audit prep. A week became a day. For a full AI gap analysis. Compliance coverage. ## Every source of audit evidence, in one assessment Connect your engineering tools, support desk, document stores and QMS. You choose what each connection can access. ## Connect. Assess. Remediate. Monitor. Act. ### 1. Connect your systems Point the agent at the systems that hold your evidence: engineering tools, support desk, document stores, and your QMS. Each connection can access only what you scope it to. Anything without a connector can be uploaded. ### 2. Assess, clause by clause The agent maps each record to the controls of every framework you carry and scores each clause. It reads the procedure and the evidence itself, so every finding cites the clause it applied and the record it read. ### 3. Remediate the gaps it finds Every gap arrives with a severity and a recommended action. Qualio helps take action, drafting procedure changes and the tasks to close each gap, while your team stays in control. ### 4. Monitor every change When a record changes in a connected system, the agent reassesses the clauses it answers. A gap opened by last week's revision shows up this week, and a fix is confirmed on the next run. ### 5. Act on what it watches Beacons watch the sources you name, such as new FDA guidance or an ISO update. When something relevant lands, the agent assesses the impact on your controls and drafts the response for your approval. [See Beacons](/agent/beacons). ## New approach to compliance and audits Keep the systems your teams use. Qualio layers on top, and takes action to drive compliance and audit readiness. ### Every connected record, read against each clause **Today: **the QMS, plus a sample pulled by hand from everything else. ### When the record behind it changes **Today: **at the mock audit, or the real one. ### The agent reads the clause and the record, and cites both **Today: **someone holds the clause in one hand and the record in the other. ### The agent drafts the fix, and your team approves it **Today: **the quality team and consultants, by hand. ### Your existing controls, cross-mapped to the new clauses **Today: **months of consultant time, starting from zero. ### Nothing. It stays your system of record. **Today: **replacing it means a migration, timed to the contract renewal. ## Start with one framework you already know Pick a standard where you already know your gaps, such as ISO 27001 or ISO 13485. Connect your QMS and two or three other systems, on a test environment if you prefer. Then compare what the agent finds with what your team already knows. - Our engineers set up the connections with your IT team - Every finding cites the clause and the record behind it - Add the next framework or system when you are ready ## Ready for your security review ### You choose the connections You decide which systems the agent connects to, from Veeva and MasterControl to Jira, and you can disconnect any of them at any time. ### Scoped to what you choose Each connection reads only the projects, document types and tags you pick. ### Your approval on every fix Each recommendation waits for a named approver. The audit trail records the clause, the evidence and who signed off. ### Certified, and audited ourselves Qualio is certified to ISO 27001, ISO 27701 and ISO 42001. ## Frequently Asked Questions ### Do we have to replace our QMS? No. Qualio Agent connects to Veeva Vault and MasterControl and assesses the documents in them against each clause. Your QMS stays the system of record, and your team keeps working in it. ### Which systems can it connect to? Veeva Vault, MasterControl, Jira, GitHub, GitLab, Azure DevOps, Zendesk, Intercom, SharePoint, OneDrive, Confluence, Salesforce and TestRail, among others. See the [integrations directory](/integrations) for what each connection reads. ### How often does it check our systems? Qualio reads Jira and MasterControl every hour and Veeva Vault every three hours. When a record changes, the agent reassesses the clauses it answers. ### Which standards does it cover? ISO 13485, FDA QMSR, EU MDR, ISO 14971, IEC 62304, 21 CFR Part 11, the ICH guidelines, ISO 9001, ISO 27001 and ISO 42001, among others, with controls cross-mapped between them. You can also build a custom framework, or have the agent build it for you, for a customer quality agreement or an internal standard. See the [frameworks catalog](/compliance-platform/frameworks/catalog). ### How is this different from InfoSec compliance tools? Most InfoSec tools run fixed yes-or-no checks against system settings, for security frameworks such as SOC 2 and ISO 27001. Qualio Agent reads your procedures and records against the wording of each clause, and covers life sciences standards like ISO 13485 and 21 CFR Part 11 in the same set of controls. ### How does a pilot work? We agree one framework and a few systems with you up front. Our engineers set up the connections with your IT team, on a test environment if you prefer, and you compare the assessment with what you already know about your gaps. ### How does Qualio manage the AI? Qualio is certified to ISO 42001, the standard for managing AI systems. The agent works only on the records you connect, every output cites its source, and every action is recorded in the audit trail. ### Can we move to the full Qualio platform later? Yes. Qualio Agent runs on the same platform as Qualio's QMS. If you later move document control, CAPA or training into Qualio, your frameworks, controls and history stay where they are. ## Which audit are you preparing for next? Start a free trial on one framework. Or book a call, and we will scope a pilot around your next audit and the systems behind it.