Case Study: The Anspach Effort, Inc. achieves 50% faster FDA audit response and streamlined document control with Document Locator

The Anspach Effort, Inc. Deploys ColumbiaSoft’s Document Control Software

The Anspach Effort, Inc., a Florida-based maker of Class I and II neurosurgical, spinal and ENT power tools, faced a growing document-management burden: more than 500,000 paper records plus fragmented electronic files on a shared server. Manual revision, review and retrieval processes slowed regulated workflows, tied up valuable floor space, and made FDA audits and long-term retention requirements difficult and time-consuming.

Anspach implemented ColumbiaSoft’s Document Locator with WebTools in a phased rollout—scanning paper records first, then importing electronic SOPs, engineering and quality documents—and used folder-level rules, custom profiles, workflows and 21 CFR Part 11–compliant digital signatures to automate control and retrieval. The result: immediate, dramatic improvements in search and approval times (audit retrieval times were cut in half), much greater process efficiency, ROI that exceeded expectations, and plans to extend the system to CAPA, ECOs, training and complaints.