Data Integrity Compliance


“Data Integrity Compliance maintains the attention of a seasoned employee while also being very useful for new hires. The presentation is to the point and provides the information very well, it keeps the trainee focused and provides them with everything they need to know and should be doing regularly.”

Lynne Marie Evers
Training Specialist, Quality Systems
Lantheus Medical Imaging

It’s in the news all the time these days: drug and devicemakers getting warning letters for failing to protect the integrity of their data. The FDA is on a quest to weed out false information and errors in the records.

A single integrity issue calls into question all the data produced by a company, FDA officials say. Investigators are already citing an increasing number of manufacturers for data integrity failures. In 2014, 13 of 18 GMP warning letters focused on data integrity violations.

Even the most seemingly minor misstep in recording data can land a company in a world of hurt – failed inspections, warning letters, recalls, loss of profit and reputation, and more.

Think about all the people in your organization who have responsibility for recording data. Do they know how to do it correctly? Do they understand the potential consequences of ignoring the rules of documentation? Can you see how critical it is that they do?

In just 10 minutes, Data Integrity Compliance can teach your employees all they need to know about the concept of data integrity, including:

  • Why your data must be beyond reproach;
  • The difference between human error and a data integrity breach;
  • Common types of mistakes and how to prevent them;
  • How to properly correct unintentional data errors;
  • How a problem that starts off as simple human error can become a serious violation;
  • Who is responsible for maintaining data integrity (answer: everyone!);
  • What kinds of actions the FDA can take against violators.

And the 10-question assessment at the end of the course verifies trainees’ understanding of the material.

Additional benefits:

  • Trainees can take the course individually and in their own time, at their own desk.
  • 10-question assessment reinforces lessons learned and allows trainees to demonstrate their understanding of the material.
  • SCORM-compliant software calculates individual’s scores and reports results.
  • Trainers can incorporate the eLearning program into their Learning Management Systems to track trainees’ progress and overall success rates.
  • Can be used by many trainees at the same time if loaded on a network or as a stand-alone course for use by individuals one at a time.
  • Includes original source files, so trainers experienced in Storyline 2 eLearning development software can customize the program to fit their needs.

Order Your Copy Today!

Product Details
when Price: $257
when Time: 10 minutes

(Add $10 shipping and handling per item shipped to the US or $35 per item shipped elsewhere. VA residents, please add 6 percent sales tax.)

Click here for the eLearning Product Specs.

Who Will Benefit

Anyone responsible for recording manufacturing process data including:

  • Drugmakers
  • Devicemakers
  • Clinical trial sponsors, sites and investigators
  • API manufacturers
  • Suppliers of materials and services to any of the above

Our Guarantee

Your risk is zero when you purchase under our money-back guarantee. Not satisfied with this product return it within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling).