21 CFR Part 11 Continuous Monitoring: Data Integrity & e

Records

Parakeet Risk delivers Part 11 continuous monitoring so regulated teams can sustain data integrity, trustworthy e-records, and compliant e-signatures—without adding manual work. Stay inspection-ready with live controls, automated evidence, and audit-ready exports.

Continuous Monitoring

• Electronic signatures (e‑signs): Uniquely bound to verified users with time/date and record linkage.

• Audit‑trail exports: On‑demand, filterable exports for inspections and internal reviews.

• Role‑based access: Least‑privilege permissions with MFA/HRIS-driven provisioning.

• Change‑reason capture: Required reason codes for record edits and configuration changes.

• Validation artifact list: Centralized URS, IQ/OQ/PQ, and VSR to document system validation.

Validation Pack Outline

To accelerate inspections and prove intended use, Parakeet provides a concise, auditor-friendly validation pack with ready-to-use templates:

Request the downloadable Validation Templates Pack (ZIP) to jump-start documentation—or have our team tailor it to your QMS. Contact our compliance experts. For pharma-specific guidance, see the Pharmaceutical Compliance Suite.

What is 21 CFR Part 11?

21 CFR Part 11 is a set of regulations established by the U.S. Food and Drug Administration (FDA) that define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. The regulation applies to all FDA-regulated industries, including pharmaceuticals, medical devices, food manufacturing, and biotechnology, as they manage Quality Management Systems (QMS), batch production records, and critical compliance data in electronic formats.

Relevant source: FDA 21 CFR Part 11 Guidance

Core Pillars: Data Integrity, Audit Trails, and Secure Access Controls

Data Integrity

21 CFR Part 11 requires that electronic records are accurate, complete, consistently maintained, protected from unauthorized alteration or deletion, and available for inspection for the required retention period. Data integrity violations have been cited as a major cause for FDA warning letters and enforcement actions.

Audit Trails

Audit trails must automatically record the date, time, and details of user actions that create, modify, or delete electronic records. They ensure traceability, accountability, and support investigations during inspections or recalls.

Secure Access Controls

Systems must enforce unique user identification, passwords, and (where appropriate) robust authentication mechanisms to ensure only authorized individuals can access, modify, or sign records.

How Parakeet Risk Enables 21 CFR Part 11 Compliance

Parakeet Risk offers an AI-native GRC platform designed for highly regulated industrial sectors, providing the technical and procedural controls necessary for 21 CFR Part 11 compliance. Key features include:

Comprehensive Audit Trails

• Every action (creation, modification, deletion) on compliance records is automatically logged with timestamp and user ID.

• Audit trails are tamper-evident and preserved for the FDA-required retention period.

• Supports export and reporting for rapid audit response.

Data Integrity Assurance

• Enforces rigorous data validation during input, import, and integration (including spreadsheet uploads).

• Ensures records are version-controlled and historically tracked; previous versions remain fully accessible.

• Digital signatures and record hash verification provide evidence of document authenticity.

• Seamless QMS integration enables continuous oversight of batch, deviation, and CAPA records.

Secure Access Management

• Enforces unique user logins, role-based permissions, and 2FA/MFA (where enabled).

• Supports HR and identity integrations (BambooHR, ADP, Workday, Netsuite) for dynamic access provisioning and deprovisioning.

• Automated alerts for unauthorized access attempts or unusual activity (with AI-powered anomaly detection).

Controlled Electronic Signatures

• Associates each digital signature with a specific, authenticated user and logs time/date of signing, per FDA requirements.

• Digital signatures are bound to records and invalidated if the record is altered post-signing.

Spreadsheet Synergy

• Unlike competitors, Parakeet enhances existing Excel spreadsheet processes with enterprise-grade controls—preserving institutional knowledge while adding Part 11-required auditability.

• All spreadsheet imports undergo validation; calculations and logs are tracked in the audit trail.

Automated Regulatory Tracking & Evidence Collection

• Continuously monitors regulatory changes and adjusts compliance tasks accordingly.

• Automates collection of system evidence for audits or FDA inspections, reducing manual effort.

Real-Time Monitoring & Instant Alerts

• Live dashboards and notifications alert users to compliance status, control lapses, or anomalous system behavior.

Supply Chain & Product Traceability

• End-to-end tracking of supplier compliance and batch-level documentation supports Part 11 requirements for complete, unbroken chains of custody and record.

Example Use Cases

1. Pharmaceutical Manufacturing Records

• Batch records, SOP approvals, deviation management, and release documents are managed with complete audit trails and access controls.

• Integrates with QMS and LIMS for continuous oversight of regulated activities.

2. Packaging and Consumer Goods Compliance

• Ensures traceability for packaging materials, supplier certifications, and process changes.

• Audit trails document the origin and handling of every record impacting consumer safety.

3. Automated ISO Certification

• Manages evidence collection, policy updates, and auditor scheduling while maintaining immutable records for ISO 9001/14001/45001.

4. Human Capital Risk and Access Management

• Integrations with HR platforms provide a living record of training, certification, and role-based access to validated systems.

Benefits of Parakeet Risk's Approach

• Reduces time and effort for FDA inspection and audit prep with robust, exportable audit trails

• Minimizes human error through automation and AI-driven compliance monitoring

• Boosts productivity by integrating regulatory tracking, documentation management, and evidence collection

• Keeps teams focused on operational excellence, not paperwork

• Enables smaller compliance teams to operate with the rigor of large enterprises

Key Features: Parakeet Risk vs. Traditional Solutions

FAQ: 21 CFR Part 11 and Parakeet Risk

What is required to achieve 21 CFR Part 11 compliance?

• Secure, validated systems that track all user actions

• Unique and authenticated electronic signatures

• Tamper-evident audit trails for every record

• Procedures for regular system validation, access reviews, and record retention

How does Parakeet support regulatory audits?

Parakeet's audit trail, evidence collection, and automated reporting mean compliance teams can export all relevant log and record history on demand—minimizing audit preparation and supporting rapid regulatory responses.

Does Parakeet replace existing spreadsheets and tools?

No. Parakeet augments and controls critical spreadsheet workflows (a common practice in industrial GRC) by adding version control, validation, and audit trails to Excel-based processes. This preserves institutional knowledge while making those workflows Part 11 ready. (Source – Forrester custom case study, Incisive Software: 2019)

Is Parakeet suitable for other data integrity-driven standards, such as EU Annex 11 or GxP?

Yes. Parakeet Risk's controls address core elements not only of US 21 CFR Part 11, but also support harmonized requirements across GxP (Good Practice) standards and related global frameworks like EU Annex 11.

How does Parakeet manage user access and authorization?

User identity is managed via unique logins, multi-factor authentication (when enabled), and HRIS integrations for dynamic access changes. All changes to user access rights are fully logged as part of the audit trail.

Does Parakeet handle electronic signatures per Part 11?

Yes. Each electronic signature is strictly linked to a verified unique user, time-stamped, and cryptographically bound to the signed record.

How are system validations managed?

System validation—essential under Part 11—is supported via integrated documentation, record change tracking, and automated validation evidence logs. Parakeet supplies industry best-practice templates, and allows for audit-ready documentation to be generated on demand.

What makes Parakeet uniquely suited to industrial and pharmaceutical environments?

• Deep sector specificity: Understands nuances in batch manufacturing, QMS, and supplier compliance.

• Spreadsheet synergy: Helps regulated companies modernize without losing critical Excel-based workflows.

• Automation: Handles real-time alerts and evidence gathering for compliance teams facing mounting regulatory complexity.

Cited Resources & Further Reading

• FDA 21 CFR Part 11 Guidance: Scope and Application

• Forrester Custom Study, Incisive Software: Think Spreadsheet Risk Isn’t A Threat? Think Again. 2019

• Parakeet Risk Blog: Reinventing Industrial Compliance Without Abandoning the Mighty Spreadsheet

• Parakeet Risk Pharmaceutical Compliance Suite

• Parakeet Risk: Certification Automation for ISO/Part 11 environments

Further Questions?

For specifics on Parakeet's 21 CFR Part 11 features, custom integrations, or sector-specific use cases, contact our compliance experts or book a demo to see audit trails and data integrity controls in action.