Government regulations determine the records management practices of pharmaceutical companies and medical research organizations. The FDA’s CFR 21 Part 11 and HIPAA’s 45 CFR Part 164 provide in depth regulations around what documents to keep, how long to keep them, and how they can be used. These include patient information, production documentation, inbound material data and research activities. These documents must be auditable and discoverable throughout a molecule’s discovery and production process.
The Lab Notebook
Bound lab notebooks and turnover binders provide the source for much of this documentation. Unfortunately, the other source of this information (the scientist’s brain) cannot be put through a scanner. Therefore, to reduce the risk of the information in these notebooks getting lost, converting them from the original paper version to electronic is critical.
Scanning lab notebooks is a straightforward process. Specialized book scanners take into account the notebook’s curvature, and incorporates image enhancement to provide a clean image right off the scanner without having to cut off bindings.
Scanning lab notebooks provides significant benefits:
- IP Preservation: digitizing lab notebooks creates a backup copy, reducing corporate risk of losing this intellectual property
- Research Cross-Population: by indexing each document, and if optical or intelligent character recognition (ICR/OCR) can be used for research findings in these notebooks, becomes much easier to find for scientists throughout the organization, which can be leveraged in the R&D process
- Compliance: helps to ensure that nothing is lost and documents can be instantly found during an audit
- Space Reclamation: less onsite storage is needed, freeing up space for more lab equipment and/or office space
Just the Beginning
Why stop at lab notebooks? Scanning other documents within the business process – including invoice processing, HR, legal, quality control (QC), shipping/receiving, the mailroom – provides similar benefits to scanning lab notebooks. You can scan the documents at point of entry, at each location or department, or you can have them scanned centrally possibly as part of a shared services solution for accounts payable.
Let NEdocs Help
We can provide you with a complementary assessment of your current processes, and identify opportunities for improvement. Whether you approach these capabilities as an outsourced model (possibly utilizing shared services if you have multiple locations), or want to set this capability internally, we can help.