Be Ready when Disaster Strikes
As outlined in ISO 22301, Business Continuity Management Systems (BCMS) ensure that critical business functions continue during and after a disaster so that the business can reliably meet its product and service commitments. Sometimes, also known as disaster recovery planning, successful businesses work proactively to enhance their resilience against disruptions and improve the speed with which they ultimately recover.
While every business should embrace the benefits of BCMS, the regulated life sciences environments have even more incentive to do so, including:
Maintaining data integrity: Multiple regulatory guidances refer to the requirement to safeguard data, including the FDA’s 21 CFR 211.68(b): Automatic, mechanical, and electronic equipment and the PIC/S Data Integrity Guidance. Both emphasize the importance of business continuity planning, data backups, and recovery capabilities as part of an overall data integrity governance program.
Continuation of support: The OECD Advisory Document 17 and Annex 11 specify the importance of ensuring continuity of support for computerized systems used for GLP relevant processes or supporting critical processes in the event of a system breakdown.
Shortening downtime: Having a business continuity or disaster recovery plan in place enables you to act faster and shorten the recovery timeframe.
Lowering financial risk: Shortened downtimes reduce lost sales and increase customer and investor confidence.
Reducing penalties: A good BCMS minimizes the risk of data breaches and, therefore, the penalties associated with mishandling sensitive patient data.
Every business should have a BCMS in place, with processes to review and update it on a regular basis. A missing or outdated BCMS will put you at greater risk for data loss, downtime, financial penalties, and reputational damage following an unplanned incident. Business continuity and disaster recovery are critical business priorities that will safeguard your company’s resilience and ensure that it can continue to thrive even in the face of the unexpected.