Medical device and other regulated industries continue to rely on manual paper-based systems to maintain their device history records (DHR). But those systems often result in product quality issues, recalls and warning letters. They can also lead to costly delays in time to market.
An electronic device history record (eDHR) solution replaces inefficient paper systems with digital production records. MasterControl eDHRTM integrates manufacturing and quality processes so companies can better manage production. The solution automates manufacturing data, documentation and line performance at every step in the product life cycle.
MasterControl eDHR captures data completely and accurately for real-time deviation tracking. It also enforces employee training and provides improved audit readiness by tracking and storing DHR data. The solution streamlines and error-proofs processes for right first time performance. It reduces cycle times and accelerates product release times for improved cash flow. MasterControl eDHR integrates quality and manufacturing processes for GMP compliance.