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Managing highly sensitive and regulated data necessitates infrastructure & mission critical support compliant with FDA, HIPAA and ISO frameworks.
Protect Your Business & Secure Your Future
Whether you are a device manufacturer, software developer or another business that serves the Life Sciences industry, you face a wide range of risks and intense regulatory scrutiny. You are responsible for meeting complex compliance requirements. You must ensure world class cyber security measures are in place throughout the lifecycle of your products and services. Data integrity and security must be rock solid. Evidence that all of these measures are in place must be readily available.
State of the Market and the Risks You Face
Questions You Must be Able to Answer
Continuity & Proactive Security
We’ve structured our services to guard against both current and emerging threats – to ensure ongoing compliance with regulatory standards.
How we Protect Your Business
| 24/7 Security Operations Center |
| Help Desk |
| Infrastructure Management |
| Vendor Management |
| Patch Management |
| End Point Security |
| Cloud Security |
| Perimeter Security |
| Backup and Disaster Recovery |
| Business Continuity |
| Compliance Services |
| Cybersecurity Insurability |
| Risk Assessments |
| Security Awareness Training |
| Incident Response Management |
The addition of a Virtual Chief Security Officer provides:
- Strategic Oversight: Engage in regular compliance reviews, IT security meetings, and executive leadership consultations. Our vCSO is your trusted advisor.
- Risk Management: Conduct thorough risk assessments and engage in proactive threat management exercises.
- Policy and Compliance Management: Oversee policy procedure reviews and ensure compliance with relevant regulatory frameworks.
Achieve Compliance
Maintaining a complete understanding of compliance within the US Healthcare Services industry, we meticulously align our solutions with regulatory frameworks established by key authorities, including FDA, HHS, and ISO
| Operations and Security Management Systems |
|---|
| FDA 21 CFR Part 820 – Quality System Regulation (QSR) |
| ISO 13485 – Quality Management Systems |
| ISO 27001 – Information Security management Systems |
| Data Security and Electronic Records |
|---|
| FDA 21 CFR Part 11 – Electronic Records / Signatures |
| FDA 21 CFR 314 – Secure Handling of Pharmacovigilance Data |
| HIPPA Security Rule 45 CFR Part 160 – Protected Electronic Health Information (ePHI) |
| Center for Devices and Radiological Health (CDRH) – Cybersec for Medical Devices |
| Cybersecurity Methodologies and Guidance |
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| NIST Cybersecurity Frameworks |
| FDA Guidance on Cybersecurity for Medical Devices |
| HIPPA Security Rule 45 CFR Part 160 – Protected Electronic Health Information (ePHI) |
| ISO 10993 – Biocompatibility of Medical Devices |
Life Sciences & Allied Industries Total Secure Plan
Our comprehensive package of IT Services is designed to simplify this process for you, covering all aspects of cybersecurity and compliance for your firm. Whether you are a device manufacturer, software developer or another business that serves the Life Sciences community, we have the expertise and experience to help you achieve your goals.
Simple. Reliable. Secure. Compliant.
ITSG Stand out among Managed Services Providers by offering integrated Compliance and vCIO services. Our compliance services align both with IT Industry best practices and Life Sciences industry requirements. Our vCIO services ensure your IT Systems are integrated with your business, making all IT decisions congruent with your plan and budget.
About ITSG
ITSG is a Philadelphia area Managed Services Provider with a specialty in the financial services industry. We have been helping small and medium-sized businesses get the most out of their IT Systems since 1987. We focus on providing the financial services industry with simple, reliable, secure, and compliant systems.
Let’s Get You in Compliance.
If you would like to discuss your situation in detail to see if we can help give us a call at 484-443-4000 or fill out this form and we will reach out to you.
