Silicon Valley and Bay Area Biotech Compliance Service

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.

  1. Physical Security Protocols
  2. IT Security
  3. Data Security
  4. Data Backup
  5. 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
  • Cosmetics
  • Medical Research
  • Any Branch of Biomedicine and Biotechnology

The FDA has two “manuals” of which you need to be aware.

  1. Compliance Program Guidance Manual (CPGM) – A guide for businesses enacting compliance protocols.
  2. 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:

  1. The Privacy Rule
  2. The Transactions and Code Sets Rule
  3. The Security Rule
  4. The Unique Identifiers Rule
  5. 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.