Navigating 21 CFR Part 11 with LabWare

LabWare gives regulated labs a direct, reliable path to meeting 21 CFR Part 11 by embedding the required controls for data integrity, secure record management, and validation into the core platform.

What is 21 CFR Part 11? 

21 CFR Part 11 is an FDA regulation finalized in 1997 that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to laboratories working under FDA predicate rules such as CGMP, GLP, and GCP. 

FDA guidance later clarified the scope to focus on essential areas: system validation, secure user access, audit trails, electronic signatures, and long-term record retention. Compliance also ties directly to FDA’s broader focus on data integrity, summarized by the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). 

How LabWare Supports 21 CFR Part 11 Compliance 

Core Capabilities 

• Audit Trails: Immutable records of all changes with user, timestamp, reason, and before and after values. 

• Electronic Signatures: Configurable for single, dual, and co-sign workflows with authentication binding. 

• Access Control: Role-based permissions, Active Directory/LDAP integration, password policies, and session management. 

• Record Retention: Human-readable and machine-readable outputs, validated archival, and controlled retrieval. 

• Change Control: Version management, controlled promotions, approvals, and impact assessments. 

Data Integrity Alignment 

LabWare LIMS and ELN enforce ALCOA+ through traceable, time-stamped, original data capture, complete reporting, and long-term record availability. Enhanced data integrity controls ensure that results remain accurate, attributable, and compliant across the entire record lifecycle.  

Global Alignment and Inspection Readiness 

LabWare solutions meet FDA 21 CFR Part 11 and EU Annex 11 requirements, with proven acceptance in FDA, EMA, and MHRA inspections. Because of this track record, laboratories using LabWare are consistently prepared for regulatory audits and inspection readiness activities.  

LabWare SaaS Solutions: Rapid 21 CFR Part 11 Compliance 

For labs needing speed without sacrificing compliance: 

• LabWare SaaS QAQC: Pre-configured workflows for analytical quality control labs. 

• LabWare ASSURE: SaaS LIMS for food and beverage labs with traceability and safety compliance. 

Both are SOC-2 certified, with deployment possible in 30 days or less. LabWare SaaS reduces IT overhead while maintaining data integrity and inspection readiness. 

Why LabWare? 

• Enterprise Proven: Used by leading pharmaceutical, biopharma, and regulated labs worldwide. 

• Inspection History: Audited by FDA, EMA, and MHRA for decades. 

• Validation Built-In: Automated test tools and validation kits reduce compliance effort. 

• Flexible Deployment: Choose enterprise-scale configurability or rapid SaaS deployment. 

• Focused on Data Integrity: Every capability is designed to support ALCOA+ principles and maintain inspection-ready records. 

Frequently Asked Questions (FAQs) 

Q1. What does 21 CFR Part 11 require from a LIMS? 
It requires system validation, secure user authentication, audit trails, electronic signature controls, and long-term record retention that demonstrate data integrity and traceability. 

Q2. How does LabWare LIMS help meet 21 CFR Part 11? 
LabWare provides out-of-the-box features such as validated workflows, audit trails, and secure signatures, along with a built-in validation toolkit to streamline IQ/OQ/PQ processes. These capabilities support ongoing inspection readiness. 

Q3. Does LabWare ELN also support 21 CFR Part 11? 
Yes. LabWare ELN enforces electronic signatures, audit trails, and traceability for research and development workflows, ensuring records are compliant and inspection-ready. 

Q4. How does LabWare differ from other vendors?
LabWare combines enterprise-scale configurability, proven regulatory inspection history, and rapid SaaS deployment options. Many competitors emphasize one aspect, while LabWare delivers all three. 

Q5. How fast can LabWare SaaS be deployed? 
LabWare QAQC and ASSURE solutions are fully validated and can be deployed in as little as 30 days, providing rapid compliance with Part 11. 

Conclusion 

21 CFR Part 11 compliance is not optional for regulated laboratories. LabWare LIMS and ELN provide the audit trails, secure signatures, and inspection-ready workflows needed to stay compliant. With both enterprise and SaaS options, LabWare offers flexibility to support any laboratory’s compliance strategy. 

Compliance-ready by design - LabWare builds 21 CFR Part 11 support into its platform from the start. Explore how LabWare keeps your lab inspection-ready with validated workflows, secure signatures, complete audit trails, and a team dedicated to your success. 

Learn more about LabWare Validation Services.