QMS Essentials

OBJECTIVE:

“I am outsourcing the manufacture of my clinical phase drug and operating virtually, but need a minimal quality management system built in-house to ensure I have good control over my contractors and release of drug into clinical trials.”

 

SCOPE FOR CEREBRO CMC:

> Familiarise with the client’s current organisation and near-term plans

> Tailor Cerebro CMC’s QMS Essentials pack to meet the needs of the client while fulfilling regulatory expectations

> Generate policies and procedures based on Cerebro CMC templates

> Refine documents based on client comments and client specificities

> Manage reviews and approvals of QMS documents

> Develop initial training plan for client staff

> Optional: provide training of client staff on their relevant procedures

 

TIMELINE:

Implementation of the QMS Essentials package typically spans a period of up to 6 months, but can be accelerated with adequate client commitment of in-house resources.