Case Study
FDA Regulated
Document Scanning
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Details
Industry: Global Manufacturing
A global manufacturer had thousands of Device History Records (DHRs) and were required to go through a manual process to request documents when needed. They were looking for an easier way to access files. Recordsforce was able to digitize the DHRs and catalogued them to be easily managed through a document management system. This resulted in a reduction of all DHR storage, saved them office space and eliminated wasted time and money on the effort required to retrieve paper documents.
Analyzing The Problem
A global manufacturer of defibrillators and AEDs was experiencing issues with filing and retrieving their Device History Records (DHRs). They had large amounts of these documents stored in a separate wring of their building and the current process made it difficult for the team to retrieve them when needed. When needing a document, members of their team had to manually request the document and wait for the retrieval team to find and send over the document, delaying the time it would take to get a needed file.
![FDA document | Recordsforce FDA document](https://recordsforce.com/wp-content/uploads/2023/03/FDA-document.png)
Creating A Customized Solution
The solution was to digitize the DHRs and make them available through the cloud. To be able to retrieve the DHRs when they were being called upon by their manufacturers, such as for an audit, it was important to digitize these documents for quick and easy access.
Recordsforce received the documents to their secure facility in Portsmouth, NH, and prepared them for digitization by removing staples and discarding any unwanted pages. The documents were then all scanned by our high-speed scanners, key data was extracted off the documents, such as lot number, and then they were quality reviewed by our team.
The DHRs were then uploaded to Recordsforce Cloud, a cloud hosted document management system. Since each DHR was indexed, this allows each document to be searched and retrieved quickly and improved their process considerably.
Instant Results
Recordsforce was able to resolve the manufacturer’s challenges and concerns by digitizing their DHRs and opening up space in their office. Along with this, the manufacturer was able to streamline its retrieval process, and are now able to find the information they need at the click of a button. This saved them a considerable amount of time and money. The organization was also able to easily manage and audit document retention with Recordsforce Cloud’s automatic retention guidelines, keeping them continuously compliant and prepared for an audit at a moment’s notice.