Case Study: Avara Pharmaceutical Services achieves 100% elimination of lost document issues and faster audit response with ZenQMS

Avara Responds Faster To Audits and Eliminates 100% of Lost Document Issues with ZenQMS

Avara Pharmaceutical Services, a contract development and manufacturing organization (CDMO) based in Norwalk, Connecticut, faced frequent missing documents, misplaced files and audit delays from relying on manual processes and legacy software for quality management. To support FDA and client audits and integrate quality into operations, Avara selected ZenQMS’s quality management system to centralize document control, training and issue management.

ZenQMS implemented a single, electronic QMS that consolidated training, issues and document management across Avara’s sites, enabling faster, more accurate audit responses and a significantly reduced error rate. As a result of ZenQMS, Avara eliminated 100% of lost-document issues, avoided audit slowdowns by pulling accurate SOP lists, reallocated resources to hire a document control specialist and removed one full-time position.

Avara Pharmaceutical Services

Heather Faber

Regulatory Compliance Analyst