Contact
g-dev™
In 2007 FDA observations of incorrectly recorded deviations and changes of production records and documents were the No. 1 in ranking of cited GMP deficiencies. Most observations were caused by failures in Deviation Management and CAPA. Even if the deviations were noted they were not usually closed out.
A deviation from approved procedures for production and process control could potentially affect quality, and therefore, compliance.
g-dev™ is a simple Deviation Management module that captures deviations from procedures, manufacturing records and protocols and takes them through a workflow, assessment and approval process so that the history and reasoning are easily seen.
Correct implementation and use of g-dev™ will:
Minimise delays to product release
- Increase consistency of your approach to handling and resolving deviations
- Provide assurance that deviations are resolved in a timely and effective manner
- Escalate according to risk and past due date
- Maintain regulatory compliance