Stay 100% Audit-Ready With Part 11 Controls and Real-Time Reporting in Regulatory Compliance Software

Stop preparing for audits with spreadsheets, email threads, and paper trails. SyberWorks’ regulatory compliance software helps FDA-regulated businesses stay audit-ready with 21 CFR Part 11 controls, automated audit trails, and real-time reporting.
✔ 100% Training
completion in weeks
✔ 100% audit readiness
across teams
✔ 25+ years of compliance
expertise

Trusted by Small and Mid-Sized Regulated Businesses

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Why Audit Preparation Breaks Down Without Part 11 Controls and Real-Time Reporting

Preparing for FDA and regulatory audits becomes risky when compliance data is fragmented.
  • Manual Processes

    Training records scattered across spreadsheets and systems

  • Manual Processes

    SOP versions outdated or stuck in email approvals

  • Manual Processes

    No real-time visibility into compliance status

  • Manual Processes

    Manual audit evidence collection consumes weeks

  • Manual Processes

    High stress, audit findings, and risk of regulatory penalties

Audit-Preparation

100% P11 Audit Readiness with a Regulatory Compliance Management Software

Not all LMS platforms support 21 CFR Part 11, audit trails, and real-time reporting equally. This comparison guide helps regulated small businesses understand what to look for in audit-ready regulatory compliance software, and why generic LMS tools often fall short during inspections.

Read the LMS Comparison Guide
Audit-Readiness

How SyberWorks’s Regulatory Compliance Management Software Simplifies Part 11 Audit Preparation

Audit-Ready-Compliance-Records

Always-Current, Audit-Ready Compliance Records


Training records, SOP versions, approvals, and acknowledgements are continuously updated and centrally stored, ensuring compliance evidence is always current, traceable, and instantly accessible without spreadsheets, emails, or last-minute audit preparation.

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Built-In 21 CFR Part 11 Controls for Defensible Audits

Electronic signatures, access controls, and comprehensive audit trails are built into the platform, ensuring compliance with 21 CFR Part 11 through validated regulatory compliance software that provides regulators with clear, attributable, and tamper-proof audit evidence.

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CFR-Part11

 

Real-Time-Reporting

Real-Time Reporting That Eliminates Weeks of Audit Prep

Automated dashboards and audit-ready reports provide real-time visibility into training, documents, and quality actions, allowing compliance teams using the best LMS for small business to answer auditor questions in minutes instead of weeks.

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Integrated Training, Document, and Quality Management Workflows

By unifying LMS, DMS, and QMS, SyberWorks automatically connects SOP updates, non-conformances, CAPAs, and training assignments, ensuring corrective actions are completed quickly and compliance gaps never fall through the cracks.

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Integrated-Training

Voices from Compliance Teams we Served

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i3 RESEARCH

21 CFR Part 11 and FDA Training Requirements for a CRO

Audit readiness

ADVANCED BIO HEALING

Training for an FDA Regulated Manufacturing Company

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PNEUDRAULICS

Training Manufacturing Employees in a Regulated Environment

What Makes SyberWorks’ Regulatory Compliance Management Software Stand Out?

  • Unified LMS, DMS, and QMS in a single platform
  • Purpose-built for FDA-regulated SMBs
  • Custom workflows and reports at no extra cost
  • Hands-on implementation and compliance guidance
  • Rapid deployment, often live in under 30 days
Regulatory-Compliance-Management-Softwar

Hands-On Support for Regulated Organizations

Syberworks has made it possible for my business to grow! These guys will work with you one on one to make sure your LMS is set up EXACTLY the way you want it to look and function. This program has allowed us to track individual students extremely easily.



Sean H.
Operations Manager, Pested.com

Syberworks personnel have collaborated to meet my growing needs and changes from day one with experience and knowledge to solve issues and work as a partner in growth. I love the support and ability of the system to meet various needs. Customer service is second to none



Lisa P.
TRAINING MANAGER, SNF HOLDING COMPANY

Syberworks provided an excellent solution for LVMPD. I was most impressed with the responsiveness and customization provided by Syberworks. LVMPD is a large organization with special training needs based on area of assignment. Having the ability to customize reports, user groups and online training was essential for our organization, and Syberworks delivered a great product.



Allen L.
TRAINING MANAGER, LVMPD

Stay-Audit-Ready

Stay Audit-Ready with SyberWorks’s Regulatory Compliance Management Software

SyberWorks streamlines audit preparation through integrated compliance automation.
  • SOPs are version-controlled, approved, and acknowledged automatically
  • Training is auto-assigned when documents or regulations change
  • CAPAs and non-conformities trigger corrective training instantly
  • Electronic signatures and audit trails ensure Part 11 compliance
  • Real-time reports provide instant proof during audits

Frequently Asked Questions

Does separating corrective actions from training increase audit risk?

SyberWorks supports 21 CFR Part 11 by enabling secure, traceable electronic records and signatures across training, documents, and quality workflows. Key controls include:
  • Electronic signatures with clear attribution (who/what/when)
  • Role-based access controls to prevent unauthorized changes
  • Time-stamped audit trails for every record and action
  • Tamper-resistant recordkeeping for defensible inspections

Can we rely on real-time reporting during live audits?

Yes. SyberWorks provides real-time compliance reporting designed for live audit situations. Compliance data is continuously updated and centrally stored, so teams can respond quickly to auditor questions without manual consolidation. Reports and dashboards provide:
  • current training status and completions
  • SOP version and acknowledgment history
  • audit trails and e-signature proof
This eliminates last-minute data pulls and spreadsheet reconciliation.

What if our workflows are complex or unique for a small business?

SyberWorks is designed for regulated SMBs where compliance processes vary across teams, sites, and roles. The platform can be configured to match your exact workflows, including role-based training assignments, SOP approval routing, escalation for overdue actions, and audit-ready reporting. This makes it practical to use the best LMS for small businesses without forcing generic templates or increasing administrative workload.

Let SyberWorks work for you

Call us directly at (781) 891-1999 to reach a sales representative.

Get a head start on Audit Preparations with a Leading Regulatory Compliance Software

SyberWorks removes uncertainty from 21 CFR Part 11 audit preparation by automating training, document control, and quality workflows in one unified platform.

Key Takeaways:

  • Always-on audit readiness with Part 11 controls
  • Real-time reporting replaces weeks of manual prep
  • Integrated LMS, DMS, and QMS eliminate compliance gaps
  • Custom workflows fit your business, without added cost
  • Faster audits, lower risk, and reduced compliance stress

See How SyberWorks Cuts Audit Prep Time!