Pharma
• FDA 21 CFR Part 11
• FDA 510 (K)
• HIPAA
• Pen Testing
• Security Risk Assessment
• Vulnerability Scan
• Third-Party Risk Management
& much more
Pharma
Cybersecurity & Data Compliance for Pharma
Pharma companies handle sensitive data related to laboratory-based research and development, clinical trials, regulatory affairs, drug safety, manufacturing, engineering, quality assurance, marketing, sales, and distribution. They are required to meet regulatory compliance requirements like HIPAA, FDA CFR Part 11, Premarket considerations of Cybersecurity in Medical Devices mandated by the FDA, etc. Preventing a data breach and protecting sensitive data from a cyber attack is critical for Pharma companies.
databrackets specializes in comprehensive assessments and customized solutions to address the unique cybersecurity and data privacy needs of organizations in the pharmaceutical industry. Our certified experts assist in protecting sensitive information like:
• Intellectual Property (Including drug, performance, and marketing information)
• Clinical Trial Information
• Protected Health Information (PHI)
Our team can also guide Pharma companies in establishing robust data protection policies, encryption, and access controls to secure data throughout its lifecycle.
Our consulting services proactively identify vulnerabilities in systems, networks, and processes, supporting your efforts to rectify weaknesses, fortify your cybersecurity stance, and mitigate risks of data breaches, penalties, fines, and legal repercussions.
21 CFR Part 11
Comply with FDA Regulated Industry regulations by protecting your electronic records & electronic signatures
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FDA 510 (K)
Comply with premarket submission requirements to the FDA to demonstrate that the device you plan to use is safe and effective
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Vulnerability Scan
Mitigate risks by getting a systematic examination of your systems or network to identify potential security weaknesses that could be exploited by attackers
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Pen Testing
Select a Standard or Premium Pen Testing Package to assess your system’s security & mitigate risks
Security Risk Assessment
Identify & evaluate potential threats & vulnerabilities to determine the level of risk to your assets & systems
Third-Party Risk Management
Protect your systems by identifying & mitigating risks from external vendors, suppliers, or partners
Consulting Services
Get expert advice & guidance from certified security experts to implement security controls & meet organizational objectives
All Services
Explore our range of Global Compliance, Cyber Security, Certification and Managed Security Services. Connect with our Experts!
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Trusted by Reputed Companies
What Our Clients Say
We used databrackets (formerly EHR 2.0) 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. databrackets (formerly 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 databrackets' (formerly EHR 2.0) 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 databrackets (formerly 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
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