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Validated System for life sciences compliance ensures all electronic records and signatures meet FDA regulatory standards, facilitating seamless audits and inspections.
The validated system for life sciences compliance maintains accurate and secure records through robust data management practices, safeguarding against unauthorized alterations.
The validated system for life sciences compliance provides detailed tracking of all system activities, enabling thorough traceability and accountability for all changes and accesses.
Validated system for life sciences compliance implements secure methods for electronic verification, ensuring that all signatures are authentic and legally binding.
Validated system for life sciences compliance reduces the risk of non-compliance penalties and ensures that training programs align with industry best practices and regulatory requirements.
GyrusAim offers robust Assessment capabilities that can be used in multiple ways: as a prerequisite, a quiz during learning.
GyrusAim LMS can effectively manage a certification process, including recertification, automated notifications, and comprehensive reporting.
GyrusAim is SCORM compliant and supports SCORM 1.2, 2004, AICC, and TinCan/xAPI content, ensuring seamless compatibility across your e-learning content.
GyrusAim LMS evaluation tools help you collect important feedback from your learners, helping you assess the effectiveness of your training and course design.
Gap Analysis provides the ability to identify skills where a learner is deficient. GyrusAim enables the learner, supervisor, or administrator to find gaps in job, organization, or certification training requirements.
For organizations operating in industries with strict data privacy regulations, self-hosting can provide the necessary control over data storage, access, and compliance.
Eliminate language barriers and offer your learners a personalized experience by choosing a multilingual learning management system. GyrusAim LMS gives users a choice of more than 15 languages.
GyrusAim LMS’s reporting capabilities provide detailed insights into learner progress, engagement, and overall performance, enabling trainers and administrators to make data-driven decisions.
GyrusAim offers secure 21 CFR Part 11 compliance, ensuring alignment with FDA regulations on electronic records and signatures.
The SF-182, also known as the Authorization, Agreement, and Certification of Training form, is a crucial document in government training programs.
GyrusAim LMS is a leading cloud-based learning management system (LMS) designed for life sciences compliance. With its validated system, GyrusAim ensures regulatory adherence, streamlined training management, and seamless audit trails. Perfect for life sciences companies seeking a secure, scalable, and compliant LMS solution for the cloud.
Ensuring the LMS operates correctly within your unique IT infrastructure.
Validating the particular instance of the application software you are using.
Engaging your internal SMEs to perform the necessary testing and verification.
Our provided documentation is designed to support and streamline your validation efforts for a Validated System for Life Sciences Compliance, offering detailed guidance to help you achieve compliance with FDA’s 21 CFR Part 11. However, the ultimate responsibility for validating the system in your environment lies with your organization to ensure it meets all regulatory and operational requirements.
While GyrusAim provides a comprehensive validation documentation package that outlines our validation strategy and processes for a Validated System for Life Sciences Compliance, it is essential for each organization to conduct the validation process within your specific environment.
While GyrusAim provides a validation documentation package that outlines our validation strategy and processes, it is necessary for each organization to perform its own validation within their specific environment. This includes using your infrastructure, instance of the application software, and subject matter experts to conduct the required testing. Our documentation is designed to support and streamline your validation efforts, but the responsibility for ensuring compliance with FDA’s 21 CFR Part 11 ultimately rests with your organization.
