Some of the brightest minds in the world have been spending years conducting research that will change the lives of patients. The millions of pages of structured and unstructured data is vital to filing with the FDA — and that data is at risk.
With strict regulatory requirements in place, biotech companies must ensure the integrity and security of their data at all times.
However, without an operationally mature IT department in place, which is the case in many biotech companies, there are complex threats that can affect the future of the work.
Here are 3 questions all biotech companies need to ask themselves if they want to maintain data integrity and security.
In biotech, collaboration between research and regulatory organizations is a key part of the process, which means sending files outside of the company and having external users access internal systems. Unless properly managed, this can open up the organization to security breaches.
Do your employees know best practices for password management and how to properly invite external users to use or view internal systems? If not, this is an area that can affect data integrity and security and put your FDA filing timeline at risk.
Working in a laboratory is second nature to everyone in a biotech company, but few feel comfortable overseeing an IT department at a high level.
In biotech, the regulatory framework can complicate how IT is managed. When dealing with multiple information management systems that are shared both internally and externally, it’s vital to have someone on your team that understands the specifics of the industry and can align them with IT best practices — which isn’t always an easy task.
A CIO can bring your IT department up to the level of sophistication as the rest of your organization so you have fully managed IT solutions that demonstrate compliance.
If you even hesitated to answer yes to this question, you might have a problem. What happens to your FDA filing schedule if your information management systems have a security breach? Once your organization can no longer verify the validity of the data, years of work can be at risk.
A BCDR plan is an integral part of an operationally mature IT department, and ensures there are multiple levels of security and recovery tactics in place so that the business’ important work can continue without a hitch.
If answering any of these questions made you feel slightly uncomfortable about where your biotech company is headed, it’s time to focus on your IT department.
Download the IT Self Assessment which offers 12 key questions that will point you in the direction of operational maturity. Your IT department can protect the integrity of your data and help you file with the FDA — if you are properly prepared.