How a pharmaceutical market leader used NetDimensions to eliminate compliance risk

Keeping workforces compliant with legislation is a major challenge in the pharmaceutical industry – and failing to do so can be extremely risky. With a seamless integration of NetDimensions technology, one market leader’s L&D team ensured they could face compliance risk and meet the demands of regulators such as FDA and EMA.

The ability to manage compliance risk is expected to become more crucial than ever in the pharmaceutical and life sciences sector by 2020 [1].

Businesses need to protect themselves from the heavy costs of non-compliance. A culture of quality is crucial to reducing and eliminating exposure to risks including financial penalties, rescinded regulatory approvals and reputational damage.

Precise auditing to meet regulatory requirements

These threats can carry equally punishing knock-on effects, such as reduced revenues, patient litigation, product recall costs and a loss of competitive ranking.

The cost of non-compliance can be crippling. For example, in May 2018, Teva Pharmaceutical Industries announced it had paid an FCPA criminal penalty of $283 million for non-compliance, with an additional $236 million to settle civil charges.

The Food and Drug Administration (FDA), the pharmaceutical regulators for US companies and imports to the US, also levies significant fines for non-compliance.

For example:

  • A fine of $15,000 per day for a missed deadline of an agreed change in operations [2]
  • Royalty payments of 24.6% per product not revalidated in time [3]
  • Fines related to profit from sales

Providing the software to meet regulatory requirements

The scale of these ramifications is one of the main reasons why our client, one of the world’s largest global pharmaceutical companies, ensured rigorous compliance monitoring was business-critical.

As well as real-time recording of their quality assurance processes, they were looking for a solution that could help them carry out the full range of auditing associated with FDA regulations.

Meeting the requirements of regulators and adhering to industry standards is vital for organizations in many industries. Training records are nearly always reviewed during a regulatory inspection or audit for 21 CFR Part 11 compliance, for example.

Introduced in 1997 and enforced in 1999, 21 CFR Part 11 is a key part of the FDA’s rules on the way electronic training records are used and kept. Non-compliance creates a risk of:

  • Official warnings from the FDA
  • Market recall injunctions
  • Bans on importation
  • Consent decrees imposing close monitoring on manufacturing and distribution

In the EU, key regulations for pharmaceutical organizations include Good Manufacturing Practice (GMP). This is a system designed to minimize the risks in pharmaceutical production and ensure that products are produced and controlled according to quality standards.

Despite the longevity of the regulation, organizations still often struggle to understand the features needed in a learning management system to be able to comply with these and other regulations and their equivalents.

NetDimensions Talent Suite, our enterprise Talent Management System, supported the business to overcome these challenges in a way that was easy to implement and manage.

Primarily, the organization used NetDimensions’ advanced software module, which is specifically tailored to meet 21 CFR Part 11 requirements.

Compliance with this requires the ability to authenticate that specific people have completed training through electronic signatures. This ensures that electronic records and signatures are trustworthy and reliable in order to meet the FDA’s regulation.

Integrating our software functionality into their existing LMS, the company’s L&D team optimized their tracking of standard operating procedures.

A photo of people looking at a tablet as part of a compliance risk assessmentInspection-ready and confident for audits

By enabling the features of the software provided by NetDimensions, the organization generated the reports needed to ensure and demonstrate compliance status and the operating process used.

NetDimensions Talent Suite’s capabilities gave them the very deep auditing capability they needed to ensure comprehensive, highly configurable reporting. Our software allowed them to track changes in the system to a highly granular level.

NetDimensions’ strong reporting tools allowed the organisation’s L&D professionals to create reports at the touch of a button, as well as monitoring performance in real time.

Just as importantly, they were able to integrate the power of NetDimensions with their existing systems and Standard Operating Procedure processes.

Successful integration through powerful technology

Companies frequently find themselves compromising when they add new technologies to their learning management systems.

Through the integration of NetDimensions software, the organization’s L&D team was able to seamlessly add crucial additional system functionality to their learning system.

This is a great example of NetDimensions’ integrative ability to meet complex industry challenges. We help organizations to precisely track changes to sensitive data and update electronic records in real time for proactive compliance reporting.

NetDimensions Learning includes a prompt for an e-signature before every important step. We maintain content revisions to ensure the accurate update of electronic training and reflect the exact version of each course.

New revisions can automatically trigger the required training to maintain the compliance needed for specific regulations in different regions.

Against the growing need to comply effectively with local and regional legislation, NetDimensions offers the capabilities organizations need to be inspection-ready.

In doing so, our technology makes the challenges faced by L&D departments easier, and allows them to continually produce clear and confident reports.

A photo of two people in lab coats looking at a computer as part of a compliance risk assessmentWant to discover how NetDimensions can help you tailor your compliance risk training to meet regulatory requirements? Contact us today.

If you found this blog useful, you might also want to download our free white paper, ‘The Role of the LMS in 21 CFR Part 11 Compliance’.

Additional sources:
[1] PriceWaterhouseCoopers, ‘Pharma 2020: Marketing the future
Which path will you take?’ (2009)
[2] Pharmaceutical Online, ‘FDA Awaits Court’s Entry Of A Permanent Injunction Against Actavis Totowa’, LLC (January 2009)
[3] BioPharm International, ‘After the Consent Decree — An Uphill Battle for Affected Companies’ (June 2004)

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