Research, Testing, and Medical Laboratories: 21 CFR Part 11 Compliance

Laboratories in the field of life sciences play an essential role in research, testing, and product development for medical devices and drugs of all kinds. […]

A Sales LMS Can Help Your Pharmaceutical Reps Thrive. Here’s How.

A large portion of the success of the pharmaceutical industry revolves around successful sales. Without good sales reps, the industry could easily falter. But selling […]

How Life Science Organizations Can Remain Compliant in the Digital Age

With technology rapidly evolving, we have seen the digitization of many processes that were once done manually. The field of life sciences is no exception. […]

Medical Device Companies and 21 CFR Part 11 Compliance

The regulations from the US Food and Drug Administration (FDA) that apply to how various life sciences companies handle electronic files and electronic signatures is […]

Biopharmaceutical Research and 21 CFR Part 11 Compliance

Whether a biopharmaceutical company is large or small, research is essential to moving industry knowledge forward and achieving the company’s mission. Does biopharmaceutical research fall […]

Life Sciences Companies and 21 CFR Part 11 Compliance

In the digital age of the twenty-first century, it’s only natural for all kinds of companies to handle more and more of their business operations […]

Training Records and 21 CFR Part 11 Compliance: What Organizations Should Know

21 CFR Part 11 applies to all digital records within your life science business. That includes your learning and development initiatives. It is important to […]

How eLeaP Complies with FDA’s 21 CFR Part 11

Life science companies are required to adhere to FDA’s 21 CFR Part 11 when it comes to digital record storage and access. These rules were […]

Demystifying the process of complying with 21 CFR Part 11

There’s been a lack of clarity around what’s needed to comply with 21 CFR Part 11, the US Food and Drug Administration’s regulations for inspecting […]

21 CFR Part 11 Electronic Records and Signatures Regulation – 20 Years On

This year is the 20th anniversary of the publication of Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11 or just Part […]

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