Many organizations in medical device and discrete manufacturing continue to rely on manual, paper-based practices to maintain their device history records (DHRs). These systems are almost always inadequate, exposing manufacturers to inefficient, error-prone production record processes, made more difficult in the face of shifting quality and traceability requirements. MasterControl’s electronic DHR (eDHR) solution can help make the process more efficient while significantly reducing risk.
How Can MasterControl Help You?
If you are using a paper-based or hybrid system, maintaining a complete and orderly DHR according to FDA 21 CFR Part 820 requirements can be an inefficient process with poor data tracking, inaccurate or missing information, and other unnecessary risks.
MasterControl eDHR™ contains all the tools that medical device and discrete manufacturing organizations need to gain control of their production data and documentation. The eDHR offering is a fully connected manufacturing records solution, connecting standard operating processes (SOPs), training, inputs, specifications, change control, quality events, and traceability. It empowers manufacturers to create and deliver an easy-to-audit record of proper handling for every major step in producing a device or product.