Case Study: Sysmex achieves faster audits and stronger compliance with Veeva Systems' Vault QualityDocs

How Efficient Document Control is Essential to Positive Audit Outcomes

Sysmex America needed a more efficient, compliant way to manage controlled documents and prepare for regulatory audits—audits and document changes were disruptive and time-consuming under their old system. After evaluating 10 CMS vendors, Sysmex sought a user-friendly, integratable, and customizable solution that would support 21 CFR part 820 and ISO 13485:2016 requirements and improve audit readiness.

They implemented Veeva Vault QualityDocs for document control, leveraging tokens, structured change-control workflows (DCC), impact assessments, lifecycle/version history, and shared regulatory files. The result was instant document retrieval, faster impact assessments (from about one month to one week), saved time from SSO/API integrations (about one hour per day), and markedly reduced audit preparation time, enabling more efficient change control and positive audit outcomes.

Sysmex