In late October of 2012, Hurricane Sandy made landfall in southern New Jersey. Due to the heavy rains and 80 mph winds, New Jersey saw flooded streets along with toppled trees and powerlines, leading to widespread destruction, including but not limited to significant infrastructural and economic damage.
This took a tremendous toll and remains the costliest natural disaster in the state’s history, but not every disaster is a superstorm. Disaster can strike in the form of funding cuts due to government shutdowns, rolling blackouts in the summer, or even the accidental unplugging of a freezer if it goes unnoticed long enough.
When a crisis arises, regardless of scale or scope, disaster recovery and business continuity planning play a critical role in loss prevention and continue to be operational. In the life sciences industry, having business continuity and disaster recovery plans is the standard, but having plans is not the same as fully understanding them.
What are Business Continuity and Disaster Recovery Plans?
The first question many ask is how disaster recovery plans and business continuity plans differ. While both target similar goals, business continuity plans (BCPs) are a proactive, comprehensive strategy to keep an organization operating during a disruptive event, while disaster recovery plans (DRPs) are reactive plans that specifically address how to recover systems and data after the event has passed.
The importance and benefits of these plans for biopharmaceutical storage and logistics is clear, since even minor temperature fluctuations can ruin pharmaceutical products and biological samples. Business continuity plans ensure that materials stay stored at their ideal temperature range to keep them in optimal condition and disaster recovery plans secure data traceability.
In SciSafe’s policies, our business continuity and disaster recovery plans are part of our 86+ Standard Operating Procedures. Our BCP is designed for the uninterrupted operation of critical services, outlining roles, responsibilities, protocols, priorities, and procedures in detail. Our disaster recovery plan includes specifics for each of our international biorepository facilities to support rapid recovery, as well as a dedicated IT disaster recovery plan, which focuses on protecting the integrity, security, and availability of all critical data systems, such as temperature monitoring, inventory management, access control, and quality system platforms. Additionally, electronic systems are backed up daily to both physical and cloud-based environments for redundancy.
Understanding the Importance of Disaster Recovery and Business Continuity Plans
As mentioned, having plans is not the same as fully understanding plans. A key component in SciSafe’s policies is to regularly review and test plans with relevant departments, including Quality and IT, to validate effectiveness as well as confirm preparedness and compliance with regulatory expectations. It is crucial that, beyond having plans in place, SciSafe is prepared to enact efficient, up-to-date methods for safeguarding irreplaceable materials. That includes widespread temperature monitoring in freezers, walk-ins, and other areas to identify and notify immediately in respect to deviation beyond typical variations due to equipment failure or even incidents as simple as freezer doors not shutting correctly, causing temperatures to rise.
In many disasters or incidents, backup power may be necessary, which is why many prepare ahead of time with generators on hand, but business continuity goes beyond just having generator power. Transfer switches are necessary for properly controlling the power supply change. SciSafe prepares for this with an automatic transfer switch, which, as its name suggests, automatically transfers the power supply from the primary source of the power grid to the backup source of the generators when a failure or outage is sensed to minimize disruption. Compared to manual transfer switches, automatic transfer switches lead to quicker response times, less potential for downtime, lower risk of human error during the transfer process, and require less hands-on effort to use, allowing our team to better focus on securing critical systems and regaining full operations.
When it comes to backup power, generators must be maintained in order to be ready for use. This includes regular checks of fluids and consistent testing, for example, SciSafe tests generators monthly and electrical load transfers annually. Our generators are always kept full, then refueled as needed through fuel level monitors that alert our fuel provider when a delivery is needed. The amount of fuel kept on hand can vary by organization, since diesel fuel breaks down over time, leaving sediment that can clog and harm the generator. SciSafe keeps enough fuel for long-term outages, as is recommended, to reduce potential waste and debris build-up.
Moreover, it is vital to account for redundancies along with backups. Extreme temperatures, like heatwaves, can cause HVAC system stress or potentially breakdowns. This can negatively impact materials being stored at ambient temperatures and lead to overworking cooling systems and freezers, which then generate even more heat from the burden. In consideration of this, SciSafe has redundant HVAC systems on standby to sustain temperature control in case the primary system fails to prevent materials from becoming inviable and biorepository operations from being disrupted.
Next Steps in Disaster Recovery and Business Continuity Planning
All in all, neither business continuity planning nor disaster recovery planning are a “set it and forget it” practice. They require ongoing reviewing and testing, as well as maintenance, to ensure that procedures can be efficient and effective when implemented for ongoing smooth operations.
Keeping policies relevant and systems current requires experts across busy teams and departments, which may already be spread thin. Rely on SciSafe for peace of mind that your invaluable samples and materials maintain their proper storage conditions, including temperature and humidity, uninterrupted by external factors. For more information regarding emergency planning, read our previous article “Emergency Planning in a GMP Warehouse” or contact us to discuss SciSafe’s emergency and disaster preparedness and why we consider continuous improvement essential.