Introduction

Parakeet Risk operationalizes 21 CFR Part 11 by turning the regulation’s core controls (electronic records, electronic signatures, audit trails, validation, and record retention) into continuously monitored workflows that align with existing eQMS and LIMS environments. The platform’s industrial‑specific capabilities, real‑time alerts, and research automation from the Rosella AI Compliance Agent keep teams audit‑ready while preserving current processes and data sources. See our pharmaceutical overview for domain specifics and QMS context: Pharma Compliance.

Part 11 controls mapped to continuous monitoring

Audit trails

• Scope: Captures creation, modification, approval, and closure events for records such as deviations, CAPAs, SOP updates, training, and supplier/lot qualifications.

• Integrity: Append‑only, time‑stamped entries with actor attribution; history views enable inspectors to reconstruct who did what, when, and why.

• Monitoring: Real‑time notifications highlight high‑risk changes or late actions; teams can subscribe in collaboration tools and review variances during daily stand‑ups.

• Evidence: Exportable activity logs and linked artifacts demonstrate control operation during inspections.

Relevant product pages: Pharma Compliance, Features.

Electronic signatures

• Attribution: Each signature captures signer identity, date/time, and signature meaning (e.g., review, approval, QA release) and binds this metadata to the signed record.

• Context: Signature workflows are embedded in SOP, deviation/CAPA, and change‑control processes; signature history is visible in the associated audit trail.

• Identity data: HRIS integrations (e.g., Workday, BambooHR, ADP) help maintain accurate user rosters and role mappings, strengthening attribution fidelity during audits.

Relevant product pages: Integration with Workday, Integration with BambooHR, Integration with ADP.

Change control

• Lifecycle: Proposal → impact/risk assessment → approvals (multi‑step if required) → implementation tasks → verification/closure.

• Traceability: Links to affected SOPs, validation documents, and training; automated creation of remediation tasks in project tools.

• Orchestration: Alerts and status updates flow to collaboration channels; compliance milestones sync to calendars to avoid due‑date misses.

Relevant product pages: Integration with Trello, Integration with Microsoft Teams, Integration with Slack, Integration with Google Calendar.

Validation artifacts (URS/IQ/OQ/PQ)

• Authoring and control: Manage URS, VP, RTM, IQ/OQ/PQ protocols, executed results, and summary reports with version control and full audit history.

• Evidence capture: Triggered workflows generate and populate Google Docs for protocols/results upon task completion, reducing manual transcription risk.

• Deviation handling: Link deviations to the impacted step and capture investigative notes, corrective actions, and re‑tests.

• Traceability: Maintain a living RTM that links requirements to tests, results, and change records to demonstrate continued validated state.

Relevant product pages: Integration with Google Docs, Features.

QMS integration and LIMS alignment

• QMS alignment: Parakeet attaches to existing QMS processes (deviations, CAPA, change control, training), providing continuous monitoring and audit‑ready records without forcing system replacement. See Pharma Compliance.

• LIMS alignment: Rosella ingests structured/unstructured data across databases, CSVs, and PDFs to correlate quality, batch, and release evidence—supporting LIMS‑adjacent monitoring and documentation. See Rosella AI Compliance Agent.

• Supplier and materials context: Link incoming quality and supplier certifications to batch records for end‑to‑end traceability when packaging or component data is relevant.

Continuous monitoring workflows (examples)

• Regulatory change → SOP update: Rosella flags new guidance; a change request is opened with proposed SOP edits, routed for e‑sign approval, training is auto‑assigned, and effectiveness checks are scheduled on the team calendar.

• Deviation/CAPA loop: A deviation triggers investigation tasks, interim controls, root‑cause analysis, and CAPA execution; validations and training updates are linked, and the record is auto‑prepared for inspection.

• Periodic review: Time‑based reviews of critical records and signatures are scheduled and escalated in collaboration channels until closure, maintaining ongoing compliance.

Evidence model and retention

• Record packages: Each requirement area maintains a complete evidence package—activity history, signatures, linked SOPs, protocols/results, and training artifacts—facilitating rapid inspector walkthroughs.

• Retention and retrieval: Centralized storage provides consistent indexing and rapid retrieval; exports allow sharing with auditors while preserving system of record integrity.

Implementation checklist (accelerated)

• Define Part 11 scope and inventory in‑scope records and workflows.

• Configure users and roles; connect HRIS to keep identity data current.

• Enable signature workflows and set required signature meanings per record type.

• Stand up change control with risk/impact templates and multi‑step approvals.

• Establish validation document sets (URS/VP/RTM/IQ/OQ/PQ) and evidence automations.

• Connect collaboration and calendar integrations for alerts and deadlines.

• Pilot with a high‑value SOP or deviation/CAPA process; run a mock audit; iterate.

See also

• Pharma industry context and QMS alignment: Pharma Compliance

• Research, monitoring, and evidence automation: Rosella AI Compliance Agent

Product sources

• Pharma Compliance

• Features

• Rosella AI Compliance Agent

• Integration with Trello, Microsoft Teams, Slack, Google Calendar

• Integration with Google Docs, Workday, BambooHR, ADP