What comes to mind when you hear the names of these United States Federal agencies? The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). Do they come across as intimidating or a positive necessity?
Whenever you hear the word “Compliance”, do thoughts of being forced to do something or denied the right to act as you wish grind on you? Or do you see compliance increasing profits, keeping investors smiling and building trust with your community and client base?
No matter how you feel, both federal agencies and compliance regulations are partners, together protecting and providing a safer environment for you, your friends and your loved ones. At times it may appear not to be that way, when you watch the news and learn Congress passed another bill, enforcing more compliance with another industry.
But without biotech compliance, how safe would your mom feel around a piece of medical equipment that releases Radiation? Or the manufacturer of children’s vaccines created them in a non-sterile environment that regulators did not check, and was going to be administered to your child? Or your pet’s veterinarian gave you a prescription, was made from chemicals, that are harmful if ingested by human or animal?
Is Biotech Compliance Harsh or Protective?
If it sounds like more government control than ask yourself, why do companies hide their waste? Pay officials to look the other way? Give money to political groups to protect their company’s interest and not the health and safety of the public? Having a body of leaders, stepping in and enforcing the rules does not hinder your business.
It allows you to work within a set of standards, which you demonstrate to your customer base or patients. Over time the public repeatedly sees and accepts the compliant standard as fair, reasonable and safe. Your company’s willing adherence to the rules demonstrates leadership in your industry. That, in turn, builds trust, repeat business and referrals.
But the hidden benefit of biotech compliance doesn’t stop there. It also helps another group even closer to you. Your employees depend on your company for steady employment and devote themselves to your mission, cause or vision. Their daily exposure to compliance builds self-worth within them, and their mindset sees themselves as protecting and helping their fellow citizens and building safer communities for children and families.
How To Out Perform Biotechnology Compliance The Federal Government Praises
First off, you want to familiarize yourself with your industry’s required compliance standards. But don’t stop there. Once you know what is required, set the bar higher. Ask questions your competitors won’t.
- What does Biotechnology Compliance Mean in (your industry name)?
- Who are the leaders in your industry?
- Who are the governing bodies for biotechnology companies and when do they meet?
- Who can help me set better compliant standards for my company?
- How do I go from preparing for compliance to compliant ready?
- Where can my team find Biotechnology Regulations Training and Compliance Best Practices?
- What are the guidelines for my biotech company becoming HIPAA compliant?
Winning The Compliance Race Begins With What You Currently Know
For your industry, assess what you know and include your management team.
- You store and maintain large quantities of data.
- You are required to house data based on federal compliance regulations.
- All your computer and software devices, including Wi-Fi routers fall under the restrictions.
- Your on-site servers, cloud-based storage, switches, and mobile devices are not exempt.
- IT compliance never stands still. Technology is evolving. Your need for risk management.
To leverage a flexible IT compliance strategy requires:
The participation of your entire staff in understanding their role in the process.
A commitment from your staff not to try to do “end runs” around the set protocols – even if a workaround may seem simpler at the time.
IT support professionals – such as KalioTekTM – who understand the internal workflow of biotechnology companies as well as how to configure your systems to deal with the complexities of IT compliance.
Continuous remote monitoring to ensure that the individual components of the compliance strategy are working as they should moment to moment.
Without these four essential pillars in place, your company will continue to struggle with the issue of compliance and won’t have confidence that you can survive a compliance audit.
There are two competing ideas when it comes to being a compliance officer in a biotech firm. One perception is that it’s a very boring position. The other says that being a biotech compliance officer is akin to riding a bike down the freeway with your hair on fire.
The truth is somewhere between those two extremes.
Biotech compliance officers have to deal with industry and legislative compliance requirements along with the internal politics of their company. It’s never easy, and it’s seldom boring.
One thing is true, however.
Compliance is always complicated – especially where compliance makes demands of your company’s IT setup, daily function, and protocols.
That’s where a team like KalioTek can leverage our biotech compliance service to help your compliance officer and aid your company in meeting the requirements of the FDA, HIPAA, GDPR, PCI DSS, and others.
Why Is It Important To Have A Managed IT Services Company On Your Side That Offers Biotech Compliance Service?
While each executive and compliance officer has their reasons for wanting to invest in IT compliance consulting, here are a few of the more common reasons we hear.
- Reason #1 – Having an outside professional weigh in on our compliance issues gives us another set of eyes and ensures that we don’t miss anything.
- Reason #2 – Non-compliance penalties and fines are so severe that we can’t afford NOT to take every precaution.
- Reason #3 – Our compliance officer is fantastic, but he/she doesn’t have the technology management skills to set up and maintain a compliant IT environment.
- Reason #4 – We don’t have a dedicated compliance officer, so we have to outsource all of the compliance work that we can.
- Reason #5 – Our compliance officer is so busy with the workflow and paperwork side of compliance that we need to help him/her by offloading the IT compliance for our Bay Area biotech firm to someone else.
- Reason #6 – IT compliance is complex, and we just don’t want to do it.
What Are The Main Elements Of IT Compliance Required Of A Silicon Valley Biotech Company?
Regulatory and industry-standards IT compliance boils down to five parts.
- Physical Security Protocols
- IT Security
- Data Security
- Data Backup
- Business Continuity & Disaster Recovery
What Do You Need To Know About Biotechnology Compliance Services?
You already know that your business leverages massive amounts of data and that HHS or FDA have expectations as to the way that data is stored and handled.
You’re also already aware that your entire IT infrastructure has to be in line with their guidelines and that you must abide by a group of pre-set protocols.
What may not be immediately apparent is that IT compliance is not a “one and done” operation. Continual risk management is necessary because of the ongoing evolution of technology.
An IT compliance strategy consists of:
A staff that has had the proper compliance education and has a working understanding of the protocols.
A staff that doesn’t try to work around the protocols that have been put in place.
IT support professionals – such as the KalioTek team – that have a working knowledge of the internal processes of biotech companies AND will optimize your systems to meet the dual goals of compliance and efficiency.
Access to IT services that include 24/7/365 remote monitoring – ensuring that elements of the compliance strategy operate as required.
If your company does not have these four IT compliance strategy elements in place, you will not have peace of mind about potential audits or your security posture.
Who Is Your Biotechnology Company Likely Accountable To Regarding IT Compliance?
You are already aware of the U.S. Department of Health and Human Services and the Food and Drug Administration. Depending on what kind of work your company does – medical research, pharmacological research, agricultural research – you fall under one or both of these governmental agencies.
Here is a brief overview of the FDA and HHS as they relate to your biotech company.
The FDA – The FDA is in charge of keeping the food supply chain of the country safe and overseeing drug development and testing. The FDA’s mandate puts them responsible for companies involved in the following:
- Drug and Supplement Manufacturing
- Medical Equipment and Devices
- Equipment or Devices that Emit Radiation
- Veterinary Medicine
- Development and Manufacture of Vaccinations, Blood, and Tissue Products
- Agriculture and Farming
- Medical Research
- Any Branch of Biomedicine and Biotechnology
The FDA has two “manuals” of which you need to be aware.
Compliance Program Guidance Manual (CPGM) – A guide for businesses enacting compliance protocols.
Manual of Policies and Procedures – Describes the documentation that the FDA requires of your company. This documentation must include your company’s internal compliance policies and documented proof that you have adhered to those policies.
These two manuals detail the minimum threshold expected of your company by the FDA. A company that hires an outside firm to deal with their IT compliance is looked upon more favorably by the FDA and is often well above the minimum expected threshold.
HHS – The Department of Health and Human Services is tasked with evaluating businesses and enforcing compliance with the Health Insurance Portability and Accountability Act (HIPAA). Of greatest concern in the HIPAA legislation is Title II. This part of HIPAA details the penalties for violation of HIPAA statutes.
HHS and HIPAA apply to any company that uses or has access to an individual’s private health information. The legislation applies to more than hospitals, nursing homes, and clinics. Any company that does business with a healthcare-related business and has access to private health information is subject to HIPAA legislation.
Here are HIPAA’s Five Important Rules:
- The Privacy Rule
- The Transactions and Code Sets Rule
- The Security Rule
- The Unique Identifiers Rule
- The Enforcement Rule
Is It Complicated For A Biotech Company To Attain And Maintain HIPAA Compliance?
The simple answer is, “Yes.”
But the truth is that you have no choice.
To make IT compliance to HIPAA legislation easier for your company and your staff, outsource that side of compliance to an IT specialist.
KalioTek isn’t just another IT consulting company. We specialize in biotechnology compliance issues.
To read more about KalioTek’s biotech compliance service, take a look at some of the outstanding articles on this topic HERE.
Looking for an IT company to help with compliance issues?
Get Compliance-related issues handled now as a standard part of your part of your IT+Security managed service from KalioTek
When the auditors are scheduled to show up, you don’t want to discover that your IT systems and processes need major projects to become compliant. You can get it handled now as part of your normal IT services -without additional expense. Well-managed IT is fundamentally secure and compliant.
Each industry has its own unique set of rules and regulations overseen by government agencies or an industry governing body. They’re always evolving and impacting what companies must and cannot do. And they all depend heavily on IT, given the central importance of data privacy and integrity.
Compliance and Regulatory Information Technology Solutions In The Bay Area
We’ve got this! As a standard part of KaliTek’s IT+Security managed services, KalioTek’s team will make sure your company’s IT is ready to pass any compliance audit without concern. We’ll answer the auditor’s questions and provide the evidence they need to demonstrate compliance with your IT systems and processes. And, as your committed IT partner, we’ll keep it compliant as requirements change over time.
The KalioTek team has the industry expertise needed and decades of experience with handling the IT aspects of compliance for life sciences, financial services and technology companies.
Whether your business is in life sciences, e-commerce, finance, or technology solutions, KalioTek’s team of experts can get and keep you compliant with the relevant regulations.
Let KalioTek worry about IT compliance so you can focus on growing your business!
What are some of the compliance regimens that KalioTek supports?
KalioTek’s compliance expertise includes:
- PCI DSS (Payment Card Industry Data Security Standards)
- HIPAA (Health Insurance Portability and Accountability Act)
- FDA (Federal Drug Administration)
- GLBA (Gramm-Leach-Bliley Act)
- GDPR (General Data Protection Regulation)
- EU-US Privacy Privacy Shield (formerly known as Safe Harbor)
Many Bay Area companies need to comply with both U.S. and European market regulations. Some of these have very specific requirements, and others are broad general frameworks. All need the expertise to interpret exactly what needs to be done in IT. You don’t need to hire special IT consultants. KalioTek has the expertise and experience to support you in all of these needs. And we’ll deliver it as part of your standard IT services.
Want to take your business to a global level? KalioTek is the team to help you become and stay compliant with the relevant industry standards and legislation surrounding data.
Let KalioTek take compliance woes off your hands.