Electronic Device History Record (eDHR)
Long predicted, the paperless office is still a myth. However, the rapid growth in technology has opened up a wealth of opportunities to automate data flow in the supply chain.
FDA regulations encourage medical device companies to harness the latest auto ID and data collection technologies to improve their delivery systems. Specifically, FDA regulations address electronic processing of printed materials used in production, product components, quality assurance, packaging, labeling, installation, maintenance, and service. These procedures were targeted because manual processes lead to endless paper trails which wastes both time and money. Not only does the continued use of paper require larger physical storage space, it also complicates data retrieval, making it labor-intensive and exhaustive.
The continued use of manual procedures in the life sciences has many potential problems that effect both the company and their clients.
| Area |
Manual procedures effect |
| End user |
Public safety; errors may cause significant harm and loss of life |
| Litigation |
Case studies show significant business losses that have in some cases resulted in bankruptcy |
| Clients |
Loss of market share to other competitors by clients and distributors losing faith. |
| FDA audits |
Delays in approvals ultimately result in late shipments |
| Quality |
Company image suffers significant setbacks in the public and customer eyes. |
| Shareholder value |
All of the above contributes to heavy losses in market capitalization and shareholder value. |
Implementing an electronic solution enables medical device manufacturers to lower their cost of compliance and improve profitability.
enLabel Benefits
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