2 out of 3
organizations say that demonstrating compliance is very important or critical to them
1 out of 2
organizations are relying on their LMS to demonstrate compliance
Only 1 out of 3
are ready for a compliance audit (for low performing organizations)
Only 2 out of 3
are ready for a compliance audit (for high performing organizations)
Training records are commonly requested in compliance audits and they must adhere to GxP regulations and guidelines.
Are your employee certifications and training records up-to-date, secure & easily retrievable in the event of a planned, pre-approval or for-cause audit of your Quality Management System?
Regulatory bodies like the FDA request that your Learning Management System (LMS) is validated for intended use.
Do you have a process in place to support this software validation with Design, Installation, Operational & Performance Qualifications?
Compliance with GxP predicate rules (e.g. 21 CFR 210 or 21 CFR 820) in combination with electronic records as per 21 CFR Part 11 or EU GMP Annex 11 for computerised systems is mandatory in regulated environments.
Is your Learning Management System (LMS) compliance-ready whether on-premise or via SaaS?
Shutdown of inspected site
Loss of license to conduct business
Delay in go-to-market plans
The US FDA documents observations/deficiencies on a Form 483. Each observation is a case of non-compliance or a violation of a regulation. The company has 15 days to respond to a Form 483. A good response to Form 483 addresses all non-compliance issues individually with a plan that includes corrective or preventive action (CAPA). Failure to respond or inadequate response can escalate to issue of a formal warning letter and further corrective actions from the regulatory body.
Get answers to common questions about 21 CFR Part 11 to help your organization comply with the United States Food and Drug Administration (FDA) Title 21 CFR Part 11.
Learn about validation, e-signatures, versioning, reporting, and audit requirements. Read this whitepaper to see how NetDimensions can help you comply with FDA 21 CFR Part 11 and GxP equivalents.
NetDimensions Learning supports auditing, e-signatures, versioning control, and reporting capabilities to meet 21 CFR Part 11 and EU GMP Annex 11 compliance requirements for electronic records.
NetDimensions Learning has been validated for US FDA Title 21 CFR Part 11 and EU GMP Annex 11 compliance requirements in client implementations worldwide. The NetDimensions validation is practical, defensible, and in keeping with the most stringent computer system validations in regulated industries.
Training records must be inspection-ready, whether they are stored as paper-based or electronic records.
When preparing for an inspection, a significant amount of time will be spent checking that records are current and agree with applicable Standard Operating Procedures.
NetDimensions Learning has secure system controls to prevent unauthorized access and to maintain data integrity and data accuracy at all times. NetDimensions' electronic records are updated in real time for pro-active compliance reporting. They are also quick and easy to access and report on, thus allowing your organisation to be inspection-ready more effectively and efficiently.
Validating your learning environment can be costly as well as time- and resource-consuming. NetDimensions provides ready-to-use consulting service packages for NetDimensions Learning to be validated in client environments worldwide for intended use along 21 CFR Part 11, 21 CFR Part 211 and 21 CFR Part 820, as well as EU GMP Annex 11 and EU GMP Part 1 requirements.
Best-in-class organisations are moving from a reactive approach to compliance to a pro-active one.
NetDimensions has been in the forefront of pro-active compliance management with:
NetDimensions Exams is a secure, high-stakes exam engine for testing the understanding of Standard Operating Procedures (SOPs) rather than just checking boxes to confirm receipt of compliance-sensitive documents.
NetDimensions Exams moves compliance from check boxes to actual knowledge assessments with a variety of exam formats, powerful workflows & unparalleled security.
NetDimensions provides all the necessary API's to link to a client's document management repository and provide a full audit trail (including electronic signatures) of who has done what, where & when in relation to training activity around these documents.
Multi-tenant SaaS models can provide challenges in highly regulated environments where software validation is required.
NetDimensions Secure SaaS combines all the benefits of SaaS with unique benefits that are specific to highly regulated environments:
NetDimensions & QUMAS (now part of BIOVIA) have partnered for a complete, best-in-class, end-to-end compliance management solution. NetDimensions Learning is integrated into the QUMAS Compliance Suite, providing a seamless learning experience on all company documents or Standard Operating Procedures and on all internal processes & best practices.