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Only 47% of compliance leaders in Life Sciences believe their reporting system gives them a comprehensive view of compliance  

43% do not believe that current compliance monitoring and reporting systems minimize the impact of non-compliance

Source: The challenge of compliance in Life Sciences – Moving from cost to value (Deloitte, 2015).

Compliance Challenges in the Regulated Life Sciences and Pharma Environments

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 and easily retrievable in the event of a planned or for-cause audit of your Quality Management System?

Regulatory bodies like the FDA request that your Learning Management System 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 computerized systems is mandatory in regulated environments.

Is your Learning Management System compliance-ready, whether on-premise or via SaaS?

 

Consequences of Non-Compliance

  • icons-fine
    Financial fines

     

  • icon-shutdown
    Shutdown of inspected site

     

  • icon-badrep
    Tarnished reputation

     

  • icon-license
    Loss of license to conduct business

     

  • icon-delay
    Delay in go-to-market plans

     

FDA Form 483 Observations

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 the FDA issuing a formal warning letter and further corrective actions from the regulatory body.

Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions.

These violations include, but are not limited to, the following: ...Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

...although the firm revised its testing procedures to incorporate the requirements for proper testing and segregation of nonconforming devices, nowhere in the report were there listed any procedures or personnel training records for review.

Our Solutions

21 CFR Part 11

NetDimensions LMS 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 LMS has been validated for US FDA Title 21 CFR Part 11 and EU GMP Annex 11 compliance requirements in client implementations worldwide. The NetDimensions LMS validation is practical, defensible, and in keeping with the most stringent computer system validations in regulated industries.

Learn more about our 21 CFR Part 11 solution

Electronic Training Records

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 LMS has secure system controls to prevent unauthorized access and to maintain data integrity and data accuracy at all times. NetDimensions LMS' electronic records are updated in real time for proactive compliance reporting. They are also quick and easy to access and report on, allowing your organization to be inspection-ready more effectively and efficiently.

Validation Services

Validating your learning environment can be costly, time-consuming and resource-intensive. NetDimensions LMS provides ready-to-use consulting service packages 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.

Compliance Analysis

Best-in-class organizations are moving from a reactive approach to compliance to a proactive one.

NetDimensions LMS has been at the forefront of proactive compliance management with:
• Competency-based compliance reporting to highlight current compliance levels and ongoing compliance risks, including the ability to drill-down to specific departments, and individual employees
• A ‘Compliance Analysis’ module that includes a set of out-of-the-box reports specific to training compliance

SOP Assessments

NetDimensions LMS contains 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 and unparalleled security.

NetDimensions LMS provides all the necessary APIs to link to your document management repository and provide a full audit trail (including electronic signatures) of who has done what, where and when in relation to training activity around these documents.

Secure SaaS

Multi-tenant SaaS models can provide challenges in highly regulated environments where software validation is required. NetDimensions LMS’ Secure SaaS model combines all the benefits of SaaS with unique benefits that are specific to complex, highly-regulated environments:
• Control over updates to support validation timeframes
• Configuration to meet your business needs and user experience
• Best-in-class security, authentication and data privacy
• ISO 27001 certification

The PeopleFluent Product Suite

Bring your enterprise talent strategy to life with best-in-class software and integrated talent suites. Power your processes with unmatched flexibility. Elevate the employee experience, drive performance, and boost your employer brand.