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MasterControl eDHR

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Data Sheet 1 Data Sheet MasterControl eDHRâ„¢ 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 eDHRâ„¢ 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. Here's how the MasterControl eDHR solution addresses some of the major challenges that companies face with their current systems managing DHRs. Challenges MasterControl Solution Inefficient processes: DHR processes conducted manually are inherently slow, cumbersome, and prone to errors. As DHRs grow greater in both size and complexity, they require more time to prepare and review and often cause delays in product shipment. Efficient processes: Automating the DHR process makes an inefficient and cumbersome manual process more efficient. MasterControl's eDHR solution error- proofs processes and eliminates common production mistakes such as missing or incomplete documentation. Plus, manufacturers can better maintain centralized, electronic records of proper handling for each significant step in the production, packaging, and holding of every device product batch. Challenges and Solutions

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