Case Study

FDA Regulated

Document Scanning

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Details

 Industry: FDA Regulated Manufacturing

 

A cosmetic manufacturer that was FDA regulated was working off of paper batch records, resulting in a timely process when needing to retrieve documents. The company was also concerned over the potential loss of their intellectual data. Recordsforce digitized their back records, bulk records and finished goods, extracted data such as formula numbers and product codes. The images and data were then delivered directly to the client. Now the cosmetic manufacturers have a quick and efficient retrieval process, while having increased safety and security over their important data and documents.

 

Analyzing The Problem

A cosmetic manufacturer was having difficulty retrieving documentation when required. Their batch records, bulk records and finished goods were all paper files within folders, making it a timely process to search for the correct documentation. They were also concerned over the potential loss of documents, from accidental misplacement or natural disasters.

documents

Creating A Customized Solution

The solution to their challenge was to convert their records from a paper format to a digital format and making the files fully searchable for easy retrieval.  To do so, Recordsforce:

 

  1. Collected all of their batch records, bulk records and finished goods
  2. Prepped them for digitization and scanned the documents (including test sponges with samples on them)
  3. Extracted the required data to make the files easily searchable, such as Formula#, Product Code and Bulk Lot#
  4. Reviewed the images and data for quality
  5. Delivered the digital records via Secure File Transfer Protocol (SFTP)

Instant Results

With the help of Recordsforce, this manufacturer no longer needs to spend time sifting through paper to find what they need. Having digital documents and data also prepared them for an FDA audit at moments notice. Other results include:

  • 100% disaster recovery of critical research documentation
  • Easily access and securely share documents 
  • Makes audits quick and painless
  • Increased safety and security