LuminLogic® recognizes that the medical device industry requires faster product implementation and is subject to regulatory review. For this reason, LuminLogic is designed to comply with FDA 21 CFR Part 11 and EU Annex 11 at the time of implementation. When platforms are designed to comply with these regulations, this ensures ongoing compliance and system integrity after the time of implementation.
We maintain both LuminLogic and the Host Environment in a validated state for all clients as part of our best-in-class Software-as-a-Service offering in compliance with FDA 21 CFR Part 11 and EU Annex 11. Optional validation services provide additional layers of assurance, helping businesses maintain regulatory compliance throughout the system’s lifecycle. These services are vital for verifying that the system continues to meet all necessary requirements for electronic records and signatures.
