How to Avoid Drowning in a Pool of Non-Compliance

Compliance is like water, if you don’t know how to manage it, you’re going to drown. If you carefully and proactively manage it, you’re going to thrive.


High-consequence industries can’t afford to turn a blind eye and ignore government regulations, especially in life sciences. The repercussions of a compliance fallout are costly, and I’m not exaggerating! The average cost of non-compliance runs an organization an estimated $9,000,000 per year.¹


Proactively maintaining compliance is not as simple as finding a technology solution to help you checkoff a list of requirements. Food and Drug Administration (FDA) driven mandates are particularly complex. Organizations are required to follow a very detailed set of principles and procedures during each stage of the manufacturing process to ensure products meet specific standards. This involves everything from raw materials, facilities and equipment standards, to the training and hygiene of staff.


Makes sense, right? Life sciences organizations exist to keep society safe and healthy and it’s the FDA’s responsibility to hold them accountable.


But, FDA regulated mandates – specifically Title 21 of the Code of Federal Regulations Part 11 – put intense pressure on product quality assurance teams to deliver, manage and report on training.


Hold up, before I lose you with the legal stuff, let me back up and explain Title 21 CFR Part 11 and how it impacts training and development.


Throughout the product development lifecycle, individuals with various roles and responsibilities are required to complete specific training courses in order to ensure safety and product quality control. But it isn’t as simple as an individual enrolling and completing a required training or certification course. Title 21 CFR Part 11 requires organizations to ensure that electronic records, e-signatures and handwritten signatures executed electronically are as trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper.


That’s where things get a little tricky.


For decades, organizations have been leveraging learning management systems to automate, deliver, manage and track training. However, in life sciences, not every LMS meets the feature, functionality and deployment model requirements of Title 21 CFR Part 11. Selecting the right LMS for your life sciences organization can feel daunting, especially when you need to understand and identify the functional, operational and technical requirements of the solution.


Don’t freak out! We put together a really useful report on the “Definitive Guide to Managing and Maintaining Compliance in Life Sciences,” which is complete with the ultimate LMS selection checklist to help you navigate the choppy waters of compliance.


Check out our compliance page and resources section for more research and insights. Leave a note below letting us know what you think!


¹Ponemon Institute, “The True Cost of Compliance: A Benchmark Study of Multinational Organizations,” 2011

Preventable Disaster: The Cost of Non-compliance

If you’re struggling to manage compliance, you’re not alone. From high-risk industries, like life sciences and manufacturing to boutique agencies and technology startups, compliance touches markets and organizations of all size. Virtually every organization has to manage a slew of constantly changing domestic and international laws and regulations.


The cost of non-compliance isn’t cheap; the average cost of non-compliance runs organizations around $9 million dollars a year. And, an estimated 68% of organizations have admitted they’ve been caught off guard by a compliance surprise.


A proactive approach to compliance management is the only way to ensure regulations are met and disastrous legal, financial and PR ramifications are avoided.


So how do you go about implementing an integrated, holistic approach to compliance? You’re in luck because we have the answer! Developing a culture of compliance that scales with your business can be easily managed through a learning management system (LMS). Here’s how it works.


How an LMS can help you easily manage ever-changing regulatory mandates:


  1. Eases administrative burden. Alleviate the headache of spreadsheets by leveraging a learning technology to deliver, manage and track learning activities. You can ensure certifications are maintained, conduct audit trails at any time, and automate and enforce policies across your organization.
  2. Reduces risk and serious financial impact. Employment-related lawsuits have increased by 400% in the last 14 years. With an LMS as the backbone of your compliance strategy, you can sleep easy knowing your organization isn’t at risk of a financial fall out.
  3. Provides a central system of record. Be ready for any surprise with a single, unified employee record that allows for scheduling based on skills, performance and certifications and automatically ensures real-time compliance with schedule requirements.
  4. Reveals who needs training (and when!). Gone are the days of organizational cat herding. You don’t have to chase down employees to make sure they complete required training – the LMS does it for you! Automatic alerts keep employees on their toes, letting learners know when they need to complete a training activity.
  5. Quickly delivers new content. Learners can access a variety of content, when and where they need it – even from their mobile device or tablet.
  6. Protects reputation to preserve the brand. Sixty five percent of an organization’s value is based on its reputation. Avoid the casualties associated with a PR fallout by implementing process efficiencies that align to corporate policies and procedures, enhance conduct and sustain confidence.


Ensure your workforce is adequately trained and avoid a costly compliance disaster with proactive learning management! To get started, check out our compliance toolkit complete with compelling research and information on building a compliance strategy.

Compliance = Organizational Cat Herding

Here’s how to get your team on-board!

You know the drill. You’ve got a compliance-based training event that has to be completed by a certain date to satisfy the powers that be (and avoid some serious fines or really bad PR). Whether it’s involving harassment, regulatory mandates (Sarbanes-Oxley, anyone?!?) or general safety training – you need to make sure your people complete the required training courses and actions in a timely manner.


Getting people to take those online trainings and achieve 100% compliance is no walk in the park. Because, to quote John Whitaker, “compliance isn’t a matter of ‘will you please’ it’s a matter of ‘you must or…’”


Unless you have an advanced degree in psychology or an arsenal of Jedi Mind Tricks, it’s impossible to get everyone to complete a required course on time.


Or is it?


We recently sat down with Kris Dunn, CHRO of Kinetix and founder of Fistful of Talent and John Whitaker, Senior Human Resources Consultant and Fistful of Talent contributor to shared their best ideas on how heard everybody through those pesky compliance training mandates.


Watch the video and follow along with the conversation on Twitter with #LDHangout!