Compliance Guides

Confluence and Comala Document Control has been used by some clients for compliance functionality for different standards.  We provide the following guides but Comalatech does not claim compliance or certification of any of our tools. In addition to taking advantage of technical elements, compliant systems must also implement the necessary procedural and administrative controls.

• Comala Document Control FDA Title 21 CFR Part 11 Compliance Statement
• Comala Document Control ISO 9001 Section 4 (Quality Management System) Compliance Statement
• Comala Document Control ISO 13485 Sections 4.2.4 & 4.2.5 (Control of Documents, Control of Records) Compliance Statement
• Comala Document Control ISO 9001 Section 7.5 (Document Control) Compliance Statement