top of page
Search
  • Writer's pictureOleg Vusiker

Elevating Regulatory Excellence: A Cutting-Edge Backup Solution for Pharmaceutical Manufacturing


In the highly regulated landscape of pharmaceutical manufacturing, adherence to the Good Automated Manufacturing Practice (GAMP) guidelines is paramount to ensuring the quality and integrity of drugs. Salvador Technologies' Backup Solution stands out as a robust and compliant tool that meets the stringent requirements of GAMP5 v2 regulations.


Meeting Key Regulation Requirements The CRU device, a disk-to-disk backup system, aligns seamlessly with GAMP5's

recommendation of backup strategies. Salvador's solution goes beyond by providing immediate insights into backup statuses, offering real-time alerts for failures, and enabling centralized monitoring through a web management system or extended log files.

Aligning with Disaster Recovery Point Objectives (RPOs) To address the need for consistent backup scheduling in line with Disaster Recovery Point Objectives, Salvador's CRU unit offers three preconfigured backup frequencies – daily, every two days, and weekly. This automatic execution minimizes human error, ensuring backups are performed at regular intervals, justifying frequency based on risk assessment.

Ensuring Correct Operation and Verification Salvador's CRU image backup capability facilitates data resilience by storing backups offsite, meeting the regulatory requirement for geographically separated backup storage. Additionally, the industry-leading Recovery Time Objective (RTO) of 30 seconds ensures rapid recovery, aligning perfectly with GAMP5's emphasis on the importance of swift data restoration.

Portable Media and Environmental Considerations The CRU unit has undergone rigorous environmental safety and electromagnetic compatibility testing, earning CE, FCC, and UKCA certifications. With a broad operating temperature range and exceptional durability (2,000,000 read/write cycles), ensures data integrity in various environments, exceeding typical requirements for backup media.


Easy Restoration Test The CRU simplifies the restoration test process by allowing users to boot directly from the backup. This feature eliminates the need for additional software or complex procedures, providing a straightforward and efficient restoration experience. Unlike other solutions in the market that rely on image backup, executing restoration tests with CRU does not pose the risk of copying data to the internal hard drive. This crucial distinction eliminates potential risks and downtime to critical Operational Technology (OT) components during the restoration process.



Salvador Technologies' Backup Solution is not just a compliance checkbox for GAMP5 v2 regulations; it's a comprehensive, user-friendly tool designed to enhance data integrity, security, and accessibility in the pharmaceutical manufacturing sector. By addressing key GAMP guidelines, Salvador's CRU ensures that critical manufacturing data is not just backed up but backed up with precision and reliability, meeting the highest industry standards.

Comments


Tech background
bottom of page