Meet your FDA compliance and eDiscovery obligations and receive end-to-end data protection with Actiance
Pharmaceutical firms are recognized for having highly regulated workflows that are subject to complex compliance processes and frequent, disruptive eDiscovery. As they deploy new communications tools, they must carefully consider the impact upon their ability to:
Forensically-sound content capture to withstand the most rigorous regulatory or legal scrutiny
Review conversations across email, social media, UC, messaging, and enterprise collaboration tools
Create policies to meet FDA and other US and EU pharmaceutical regulations
Meet FDA record keeping and preservation requirements with a WORM-compliant content store
Identify and eliminate insider anomalies to securely protect sensitive data inside enterprise bounds. With real-time Data Loss Prevention both out-of-the box and customizable policies, it is effortless for administrators to enforce policies instantly and at scale. Sensitive data detection capabilities include scanning files in-content and blocking sensitive files from being transferred or downloaded.
Pre- and post review of social content to enable compliance with FDA guidelines on presenting risk information of prescription drugs, correcting third party misinformation, and responding to Off-Label Prescription Drug information
Meet FDA 21 CFR Part 11 retention and disposition rules for individual document retention requirements per process – R&D, protection of IP, drug trials, new drug approval, drug labeling, etc.
Harness sub-second search, granular search filtering, and advanced analytics to spot compliance violations hidden within data and leverage full APIs to deliver communications data to downstream apps for full content surveillance.
Pharmaceutical firms are recognized for having highly regulated workflows that are subject to complex compliance processes and frequent, disruptive eDiscovery. Actiance enables the compliant use of 80+ communications channels to meet FDA and international pharmaceutical regulations with confidence. The Actiance Platform includes:
“The average number of tweets by pharmaceutical companies has gone up by 530% since 2013 ”Ogilvy Health World, 2015
Social media platforms have increasingly enabled drug and device manufacturers to more actively engage with consumers and healthcare professionals. The FDA has taken notice by producing guidelines for the use of social media by pharmaceutical companies as early as November 2009. It brought together various stakeholders from the industry with the aim to gather input on how the FDA can provide guidance on the use of social media to promote FDA-regulated medical products.
The information gathered was incorporated into four draft guidelines addressing various elements of the promotion of medical products on social media platforms including:
1. Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
2. Internet/Social Media Platforms with Character Space Limitations
3. Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
4. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
As social media and collaborative communications channels continue to become more diverse and feature-rich (consider voice, video, app sharing, etc.), one can expect that pharmaceutical providers will find new ways to leverage social media to reach the market with their products, which will likely trigger additional guidance from the FDA, and a greater premium on approaches to automate policy enforcement.
Title 21 CFR Part 11 is the part of Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA rules require them to maintain.
21 CFR Part 11 also mandates which records must be maintained; the content of records; whether signatures are required; how long records must be maintained. Subpart B states that company’s systems must be able to generate accurate and complete copies of records (specified in the rules) in both human readable and electronic form suitable for inspection, review, and copying by the agency.
To demonstrate compliance with 21 CFR Part 11, Pharmaceutical organizations need to be able to demonstrate to industry regulators that reasonable steps have been taken to supervise and capture employee use of communications and social channels. A WORM archive is required to meet rigorous regulatory storage requirements, as well as to prepare for the very frequent likelihood of civil litigation and eDiscovery.
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