Case Study: FDA Regulated Documentation


Challenge:

A makeup 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.

 

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)

 

Result:

With the help of Recordsforce, this manufacturer no longer needs to spend time sifting through paper to find what they need. 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