Regulatory Training in Life Sciences

Are you compliance-ready?

Compliance is critical to life sciences organizations

2 out of 3
organizations say that demonstrating compliance is very important or critical to them

and

Life Sciences uses LMS to demonstrate compliance

1 out of 2
organizations are relying on their LMS to demonstrate compliance

but

Compliance audit readiness low-performing organization

Only 1 out of 3
are ready for a compliance audit (for low performing organizations)

Compliance audit readiness high-performing organization

Only 2 out of 3
are ready for a compliance audit (for high performing organizations)

Source: Brandon Hall Group

New 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 & 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?

Consequences of non-compliance

Financial fines for Pharma & Life Sciences

Financial fines

Shutdown of inspected Pharma & Life Scienses site

Shutdown of inspected site

Tarnished industry reputation

Tarnished reputation

Loss of license to conduct Life Sciences business

Loss of license to conduct business

Delay in go-to-market plans

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 issue of 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.

Comply with FDA 21 CFR Part 11

Checklist

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.

Download Checklist

White Paper

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.

Download White Paper

Our Solutions

21 CFR Part 11

21 CFR Part 11

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.

Learn more about our 21 CFR Part 11 solution

Find out about the role of the LMS in 21 CFR Part 11 compliance

21 CFR Part 11
Electronic Training Records

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 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.

Electronic Training Records
Validation Services

Validation Services

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.

Validation Services
Compliance Analysis

Compliance Analysis

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:

  • 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
  • ‘Compliance analysis’ module in NetDimensions Learning that includes a set of out-of-the-box reports specific to training compliance
  • NetDimensions Analytics, a state-of-the-art talent analytics application
Compliance Analysis
SOP Assessments

SOP Assessments

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.

SOP Assessments
Secure SaaS

Secure SaaS

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:

  • Control over updates to support validation timeframes
  • Customisations to meet your business needs & user experience
  • Best-in-class security, authentication & data privacy
  • ISO 27001 certification

Find out the right questions to ask when selecting a SaaS vendor

Secure Saas

Share these industry insights and solutions with your team — download NetDimensions' Life Sciences Solutions brochure and take the next step in discovering fully integrated learning and performance management for your organisation.

NetDimensions & QUMAS: End-to-end Compliance Management in Life Sciences

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.

NetDimensions & Qumas: End-to-end Compliance Management in Life Sciences

Find out what this partnership means to you

NetDimensions Life Sciences Clients
 
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