Case Study: Abiomed achieves 30-day implementation and improved CAPA visibility with Sparta Systems' TrackWise Digital

Abiomed Implements 123 Compliance EQMS Solution Within 30 Days

Abiomed (NASDAQ: ABMD) is a global medical device leader focused on recovering hearts and saving lives. The company sought an easy-to-configure, cloud-delivered EQMS that could be validated and maintained according to internal SOPs and external regulatory requirements.

Abiomed selected TrackWise Digital for its intuitive cloud design and out-of-the-box executable validation package, enabling management of processes from discovery through investigation, root-cause analysis and final approval with FDA/ISO alignment and 21 CFR Part 11 compliance. The solution was implemented and validated in 30 days, rapidly improving visibility into CAPA and audit findings and delivering the required functionality on the Salesforce App Cloud.

Abiomed

Suzan O’Leary

Project Manager