Life sciences organizations are subject to strict regulatory compliance measures due to the proprietary nature of their data. IT teams within these organizations have a hefty responsibility to protect and secure company data from cyber threats, natural disasters, and internal exposure either by accident or malicious intent.
The decision to work with a cloud hosting provider is a significant decision because it introduces a third party into the equation. It is crucial to choose the right hosting provider as your partner, particularly for regulated companies. Careful consideration should be taken when making this selection specifically as it relates to compliance.
ByteGrid has a long history of working with regulated companies in the life sciences industry and employs a staff of experienced IT veterans that specialize in GxP compliant hosting and meeting the highest standards. Most of our life sciences customers have come to us after an exhaustive review of GxP compliant cloud hosting providers. In addition to the necessary core services and requirement to meet compliance, a thorough review includes future needs, such as cloud capacity and cloud services, that will be required to accommodate growth.
Here are a few of the key items to look for when considering GxP compliant cloud services:
Cloud-based solutions used for GxP activities must be validated in order to demonstrate regulatory compliance. The underlying infrastructure should be qualified before validating. There are many variances in offerings across multiple hosting providers. At ByteGrid, we staff experienced quality management & security teams. We ensure that our data centers are validated and compliant with all requirements of Part 11 as well as the many other standards to which we adhere. These professionals are CISA, CRISC and CISSP certified and take pride in managing customer deployments with individualized care.
When it comes to selecting and managing their cloud provider, regulated companies look for a partner that will help them to understand security risks and will keep their system secure over the entire system lifecycle. Due diligence begins with an audit, especially for higher risk systems. The audit will reveal whether security solutions have been presented truthfully and are consistently in place for affected systems. Cloud hosting companies that specialize in GxP compliance go the extra step – in addition to offering robust security solutions, they take the time to make sure that there are no security gaps that could trigger compliance violations.
A hosting provider that specializes in GxP compliance will have incidence response procedures clearly documented and tested. Successful companies confirm that all associates at the hosting provider are fully trained on incident response procedures for their roles.
At a high level, incident prevention and response should include three basic components:
Assess and Capture – The first step in preventive incident prevention is to create a base line “snapshot” of your entire network. ByteGrid’s qualification process sets the baseline, and includes an initial vulnerability assessment to ensure that the initial baseline is free from security weaknesses.
Plan and Prevention – Incident response planning isn’t limited to just tools and services, it includes training and detailed documentation. All associates are trained on incident response procedures for their role.
Test, Practice and Review – Practice makes perfect. By going over these procedures repeatedly, staff is equipped to respond quickly and effectively should an incident occur. Additionally, all regulated systems are subject to periodic review of risks and risk control measures to ensure that the tools and services in place continue to function adequately to mitigate risks as systems and threats evolve.
These are key points to consider when choosing a GxP compliant cloud hosting provider.