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Comprehensive 21 CFR Part 11 Compliance

GyrusAim LMS offers secure 21 CFR Part 11 compliance, ensuring alignment with FDA regulations on electronic records and signatures. Features include electronic signatures, course versioning, auditing capabilities, and robust data security measures, essential for regulatory compliance in industries like pharmaceuticals and food.

21 CFR Part 11 LMS Feature

GyrusAim LMS with Robust Capabilities

GyrusAim self-hosted LMS offers the following benefits

21 cfr part 11 lms software features

Audit Trails

Comprehensive audit trail tracking changes to ensure regulatory compliance

Electronic Signatures and PINs

Electronic signatures, when used in conjunction with PINs, ensure the integrity of electronic records. Ensures that once an entry is made and signed, it cannot be changed without leaving an audit trail

Identity Verification

Electronic signatures combined with PINs help verify the identity of the user who is signing a document or logging into the LMS. This ensures that the person accessing the system or signing records is authorized to do so, providing a secure layer of authentication

Track Content Versioning

All course versions must be tracked so that updates can be communicated to users. Accurate version control and historical content access are critical requirements for compliance with 21 CFR Part 11

Instant Access to Training Records 24/7/365

Authorized personnel have continuous access to training records, enabling swift data retrieval as needed for audits or inspections, and ensuring compliance with accessibility requirements under 21 CFR Part 11

Validated System

GyrusAim LMS undergoes extensive validation processes, including over 130 QA steps. This confirms its compatibility with FDA-regulated organizations and compliance with technical standards outlined in 21 CFR Part 11

What Makes GyrusAim The Best Fit for You?

Let our Experience
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GyrusAim is a Leading Learning Management System (LMS)

GyrusAim simplifies compliance training by providing an intuitive platform with streamlined processes. Our user-friendly interface and comprehensive suite of features make it easy to create, manage, and track compliance training. Automate reminders, track progress, and easily generate reports, ensuring that your organization stays compliant with regulations.

FAQs

Can GyrusAim Self-Hosted LMS work for organizations of any size?
GyrusAim’s self-hosted LMS is scalable to account for organizations of different sizes and provide LMS solutions according to their requirements.
GyrusAim’s self-hosted LMS integrates with existing systems to enable efficient data exchange and streamline operational processes.
GyrusAim provides users with dedicated support staff via phone or email and an extensive online community for further support.