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Zoll’s procedures for processing non-conforming material disposal forms, incoming inspection), as well as reports of unsatisfactory conditions, were based entirely on paper and labor intensive.

Once signed, the appropriate steps to be executed could be decided, such as returning a defective part, repairing it, etc. The process from the moment of creating the form until signing could take up to 35 days (depending on the particular form).

Our Solution

The manual paper process was emulated with a robust workflow (Workflow) that meets all the requirements of FDA 21 CFR Part 11 and in particular with the use of electronic forms (eForms DC) and the application of electronic signatures with a forced double authentication.

Due to the flexibility to customize the solution, the electronic forms module is directly integrated with Zoll MS Access databases.

After the implementation has been carried out for only 2 months, the first results have shown an immediate improvement compared to the original paper-based system.

Some measurable early results are: reduced processing time for Material Disposal Forms (from 23 to 4 days) and other key parameters up to 81%. This translates into lower paper and file scanning expenses; Other subsequent benefits are the higher yield of material and production, as well as a significant reduction in paper consumption.