AI for pharmaceutical quality: an assistant and agents that work with human approval

What the module does

• Q Intelligence searches records, attachments, audit trails and projects, then the regulatory library, preferred websites and the open web, and lists what was consulted: every record, document, guidance passage, web page and connector call it used.
• Regulatory answers cited by document, code and page from the regulatory library: FDA guidance and regulations, ICH quality guidelines, EU GMP, EMA and PIC/S indexed from the official documents, with your licensed ISPE and PDA copies searchable for your users.
• Draft cards for an investigation, change control, CAPA, document or record link: Review and create opens the form pre-filled, and the record exists only when a person creates it.
• Analysis in the conversation: control charts, Pareto and other charts from your data, hypothesis tests, and draft FMEAs and PFMEAs built from deviations, investigations and SOPs for the team to review.
• Q Agent works a goal to a visible plan, reads the records with read-only tools, and proposes actions (log a complaint, open an investigation, draft the root cause analysis, run backlog triage or signal detection, flag a record, send an email, schedule a recurring agent), each with a reason a reviewer can check.
• Two levels of autonomy: ask before every action, or create drafts without asking, under which flags, emails and schedules still wait. Actions run with the approver's own user permissions, never administrator authority.
• Scheduled agents for daily huddle prep, overdue CAPA chasing, APR/PQR data packs, QMS gap watch, management review packs and inspection readiness: they read records, write a report and propose emails or flags for approval.
• Alerts and watches: built-in rules for records left waiting, such as a possible adverse event without a decision or a prior-approval change without a regulatory decision, plain-language watches, and Ask Q Agent to work this.
• AI final review before a record is routed: the AI reads it as the reviewers will and lists must-fix, should-fix and consider findings with a suggested fix; it changes nothing.

How it fits the platform

Q Intelligence and Q Agent read the same records as every module: complaints, investigations and CAPAs, change controls and documents, validation, risk assessments and submissions, the LIMS, ELN, MES, calibration and CMMS, with their audit trails. Administrators can connect the organization's own systems as tool connectors; the chat offers only the tools a server declares read-only, and a change in a connected system goes through Q Agent, where each action waits for approval.

The REST API and the MCP server let other systems and internal agents read records and start Q Agent tasks; records are read-only through the API and every action a task proposes still waits for approval.

Where people decide

The AI drafts, searches, analyses and proposes; people create the records, approve or dismiss each action, review, decide and sign. Records Q Agent creates start in review and still need a qualified person to review and sign. Text in records, files, web pages, alerts and connected systems is read as data, never as instructions: if it contains instructions, the AI says so and does not follow them.