Is Your Biotech Organization Compliant?


We’ve outlined 6 questions every biotech organization should ask themselves to ensure their IT systems are compliant.

As a biology, chemistry, or engineering laboratory environment, compliance is ingrained into every action your employees take. From their clinical research to data collection to collaborating with external organizations, there are strict regulatory rules they have to follow. Compliance not only protects your organization from risk, but also ensures that you comply with the laws and regulations in place for your industry.

While many biotech organizations are familiar with the compliance aspects as they pertain to their research, they do not have a deep understanding of compliance when it comes to their IT systems and processes.

A critical component of an effective IT compliance program is a Business Impact Analysis (BIA), which quantifies the impact of a disruption to your operations such as from a natural disaster, security breach, or major accident. Similar to having a business continuity and disaster recovery plan in place, a BIA enables organizations to identify any gaps within their compliance agreements, such as with HIPAA, GDPR, or CMMC.

Start your Business Impact Analysis

In a Business Impact Analysis, biotech organizations need to first identify their critical processes and functions and determine what is absolutely necessary for their operations. By knowing what is critical, they can then begin to draft a roadmap for their business recovery. Through this process, it’s possible to see whether there are any resource interdependencies and if certain functions rely on the same resources.

Biotech organizations need to determine the impact of an incident, analyze the processes and functions necessary for operations, and evaluate recovery times from an operational disruption.

In order to conduct an effective Business Impact Analysis, it’s important to start by asking your organization these 6 questions:

1. What immediate steps do we need to take with our IT systems to become compliant?

Many biotech organizations have small IT departments with just one or two people. This leads to improper firewall management and poor incident prevention practices. Some IT departments don’t have any business continuity or disaster recovery plans, either.

Other common compliance gaps include a lack of documentation for sensitive data flow and a failure to document any preventative measures. These should be prioritized in order to demonstrate compliance.

2. Do we have a data governance strategy in place that considers compliance requirements?

Your data is the lifeblood of your organization. It comprises hundreds of thousands of pages and has taken years of research to compile. What if the IT systems governing your data are not compliant?

An effective data governance strategy ensures that your research and analysis are well managed and in accordance with internal and external regulations. It also ensures that your employees — who are responsible for directly working with the data — are well informed about how to access or share it.

3. How long will it take us to bridge compliance gaps in our IT systems?

Speed is essential when your current systems are not fully compliant (or you’re not sure of the status of your compliance). It’s best to fill compliance gaps as quickly as possible. If you don’t have resources in house that are experts in maintaining compliance for your IT systems, it’s best to work with a managed services provider that can guide you through the process.

4. Do we have in-house expertise in this area?

If you’re like most biotech organizations, it’s likely that the answer to this question is no. While maintaining compliance in your research and data integrity is of second nature to you, you may be unfamiliar with the nuances in the IT world. Opt to work with an IT provider who is experienced in biotech and understands the compliance requirements relevant to your industry.

5. Can work be completed within an acceptable time frame?

Regardless of whether you’re relying on your internal IT department or working with an external IT firm, having a schedule to fill compliance gaps is key. The longer your IT systems remain unchecked, the higher the possibility of vulnerabilities, data exposures, data loss, or even regulatory fines.

6. What is the best way for us to accomplish our IT systems compliance goals?

The priority for many biotech companies is to ensure the integrity of their data, keep their research on schedule, and file with the FDA. Your IT systems need to be able to support your goals, not hinder them. Avoid operational issues and non-compliance related fines by putting a plan in place as soon as possible.

You don’t need to establish and maintain compliance alone.

Whether your overloaded IT department is lacking compliance expertise or the bandwidth to ensure the right processes are in place, it’s time to bring your IT systems up to the level of sophistication as the rest of your organization.

Not only can a managed IT partner like JPMerc ensure your systems are compliant with all the relevant regulations for your organization, we can also conduct regular Business Impact Analyses and risk assessments to help quickly detect, estimate, and prioritize risks to your individuals, assets, and operations.

As a trusted partner to biotech organizations, we handle all IT operations so you can focus on your life-changing research.

Learn more about how we work with biotechnology organizations.