21 CFR Part 11
Compliance for FDA regulated Industries
• Assessment Report
• Policies & Procedures
• Remediation Tracking
• Action Plan Reminders
• Form Templates
• Vulnerability Scan
• Pen Testing
Demonstrate your Compliance with 21 CFR Part 11
21 CFR Part 11 is a Code of Federal Regulations issued by the U.S. Food & Drug Administration (FDA). It outlines the requirements for electronic records & electronic signatures in industries regulated by the FDA. These industries include Pharmaceuticals, Biotechnology, Medical Devices, Tobacco & Nicotine Products, Food & Beverages, Cosmetics, Animal Food & Drugs, Blood & Blood Products.
21 CFR Part 11 was established to ensure the authenticity, integrity, & reliability of electronic records & signatures used in various aspects of the FDA-regulated industries. These regulations provide the framework to ensure that these electronic records are trustworthy & can be used as substitutes for paper records, thus streamlining processes & enhancing efficiency in regulated industries.
Connect with our Certified Security Experts to assess your controls and prove your compliance with 21 CFR Part 11 by sharing your assessment profile. Our engagement options are ideal for organizations of all sizes with and without an experienced in-house IT team. Connect with an expert or schedule a consultation to explore the option that is best for your organization.
Engagement Options
DIY Assessments
Our Do-It-Yourself (DIY) Assessments are ideal for organizations with an in-house IT team that is aware of regulatory benchmarks for your industry & able to provide evidence documentation to prove you are compliant
Hybrid Services
Our Hybrid services include our DIY packages along with Consulting hours with our certified security experts to guide your team & successfully meet the benchmarks of the standard
Consulting Services
Our Certified Security Experts work with your team to meet global cyber security & privacy benchmarks, organize evidence documentation, customize policies, create remediation plans, & much more
Choose a plan that fits your need
Explore Blogs, Webinars and other Resources
Trusted by reputed companies
Accreditations and Associations
What Our Clients Say
We used EHR2.0 in our small medical practice for our risk analysis assessment to be in compliance with meaningful use. Their response was fast, the final report is detailed but simple and easy to follow. They were always available to answer our questions.
E. Compres
Pulmonary and Sleep Center of the Valley
I never miss the opportunity to learn something new …that’s why I am always registering to all free seminars offered on the web. EHR 2.0 happened to be the friendliest, comprehensive and up-to- date source of HIPAA Privacy and Security updates.
Alexandra V.
Community Healthcare Network
Today’s presentation was great! Thank you for sending the slides. My only feedback is that it would be fabulous to have the slides ahead of time so I could print them and take notes on the slides.Thanks for your time and knowledge today!
T.B., PM
Community Health Network
Particularly interesting was the flow chart on Administrative Simplification. I utilize all of the Security subcategories you list under the Security tile and appreciate knowing that I am hitting all of the relevant topics during my employee training.
Jessica B.
JD, CHC
I have re-worked our original risk assessment….We are using EHR2.0’s Meaningful Use Security Risk Analysis Toolkit and it meets our needs. It was easy to use and I believe that it very beneficial to our meeting meaningful use.
Bill Curtis
Neurosurgical Associates Of Texarkana, TX
Information (webinars) presented by EHR 2.0 highlights some of today’s most demanding healthcare topics. The webinars help to direct those operating in today’s rapidly changing environment in the right direction.
Candace M.
Privacy and Security Officer, Springhill Medical Center
Our Growing List of Credentials
0
+
Assessments
0
+
Clients
0
+
Assessment Libraries
0
+
Years of Experience
0
+
External audits handled