Device Manufacturer Ensures Compliance

A leading, global medical device manufacturer greatly improved efficiency by partnering with BerkOne to manage and maintain their documents. This medical device manufacturer needed a cost-effective solution to manage the substantial number of internal documents generated on a daily basis as part of doing business.
The Challenge

A leading global medical device manufacturer realized their internal imaging department had grown too costly and time consuming to maintain. After a year of evaluating several vendors, they found BerkOne to be the only vendor that could provide the level of quality and audit for medical records management that mirrored their own strict manufacturing requirements.

The BerkOne Solution

BerkOne converts all of the paper documents this client creates in the course of doing business into PDF images including DHR (Device History Reports), MC (Manufacturing Change Orders), and REV (Revision) files, Compliance Journals, Large Format Engineering drawings, Accounts Payable Invoices, Expense Management, and internal software testing/validation documents. Images and corresponding metadata are uploaded to the clients secure FTP (File Transport Protocol) site from which the client then downloads the electronic images of their documents from the FTP site into their internal content management software.

BerkOne developed a custom script for the FTP upload to assure that each automated upload was reconciled. The physical records are then stored in BerkOne’s storage facility with some returned to the client, at their request, for auditing. This gives them easy access to the information contained in the documents and also frees up storage space at their sites.

The Results

By creating an electronic image of each document generated, the manufacturer no longer needs to have all of their paper records on site—a more secure solution in the event of a disaster and an opportunity to make better use of floor space. Additionally, their Accounts Payable department receives searchable PDF files allowing auditors to locate keywords across large volumes of images.

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