Documentation Control
Stop the "Version Confusion" before it becomes a Finding.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Outdated SOP Distribution
Is your team working off outdated SOPs because the new ones aren't distributed?
Documentation Lag
Are DHF and DMR updates lagging behind production changes?
Paper Signature Chaos
Drowning in paper signatures and lost change orders?
The VigilaMed Solution
Rigid Yet Efficient Document Control
We implement rigid yet efficient Document Control systems that ensure data integrity (ALCOA+) and traceability without slowing down the speed of innovation.
Manufacturing-First Methodology: Our document control systems balance strict regulatory requirements with operational efficiency, ensuring version control and traceability without bureaucracy.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Document Control SOP
- Change Control Workflow
- DMR/DHF Indexing Structure
- Version Control System
- Document Distribution Protocol