What’s new?

The comprehensive guide to business email management

An effective email management framework for your business

Resources

Blog

Check out our blog for the latest on email management, news and more!

Case Studies

Find out how we've helped customers like Ramboll and Gensler.

E-books

Download our latest content to help you along your email management journey.

Implementing Ideagen Mail Manager

Hear from our customers how they implemented Ideagen Mail Manager and the benefits of doing so.

Podcast

Listen to all episodes of the Changing Construction and Digital World of Tomorrow podcasts.

Webinars

Hear about a variety of topics including risk, the digital world and more!

Potions and protocols: FDA, FTC, and email management

7 February, 2024

Imagine a world not unlike the corridors of a wizarding school, only here the spells and incantations are replaced with compliance regulations and audits. Here, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are revered sorcerers, safeguarding the enchanted, yet perilous world of life sciences. 


The two pillars: FDA and FTC


The FDA primarily focuses on ensuring the safety and efficacy of drugs and medical devices, while the FTC enforces antitrust and consumer protection laws. According to the official FTC website, both agencies require stringent record-keeping across various aspects of a company's operation, from product development to marketing and antitrust behavior. Failing to maintain accurate records can result in severe consequences, including substantial fines and legal actions. 


Documents and records


As mentioned, ensuring compliance with regulations, and maintaining quality standards is crucial. A critical component of this ecosystem is the diligent maintenance of documents and records. Take for instance medical devices, records not only serve as evidence of compliance but also act as a detailed blueprint for the manufacturing, quality assurance and servicing of the devices. Accurate record-keeping is essential for the traceability and accountability of devices, especially when discrepancies or issues arise.

Now, let's explore the need-to-knows for maintaining records.


Records - general requirements


  • Records should be maintained at the manufacturing site or a reasonably accessible location.

  • They should be legible, stored securely, and backed up.


Record retention


Records must be retained for the expected life of the device or at least 2 years from the date of release for commercial distribution.


Device master record


Must include:

    • Device specifications

    • Production and process specifications

    • Quality assurance procedures

    • Packaging and labeling specifications

    • Installation, maintenance and servicing procedures


Device history record


Must include dates of manufacture, quantity manufactured and distributed, and acceptance records.


Quality system record


To be prepared in accordance with 21 CFR 820.40 and should include or refer to documentation of activities not specific to a particular device.


Learn more about how to manage emails and ensure compliance


If you're ready to don your robes and wield your wand in the art of email management, our free eBook awaits you as your guide.

MM_maitaining_compliance_in_Life_Sciences_ebook_banner


Download the eBook now and discover:


•    Why email management is essential for staying compliant
•    Practical tips for regulatory success
•    Best practices for the management of documents and records

Get your free eBook now!

Suggested:

Life Sciences

Navigating the chamber of compliance secrets

Mail Manager
Ensuring the safety, quality, and efficacy of products in the highly regulated pharmaceutical and life sciences industry is paramount. Good...
Read more
Life Sciences

Turning compliance nightmares into golden opportunities

Mail Manager
In the dimly lit backrooms of regulatory compliance, where the sharp contours of audits and inspections cast long shadows, one might be surprised to...
Read more