A number of government regulations dictate 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 painstakingly detail the regulations around record keeping. These include not only patient information, but also stretch to manufacturing documentation, supplier information and research activities. Organizations must provide auditable and discoverable records of every step of a drug’s discovery, testing and manufacturing.
In addition to the aforementioned regulations, domestic and international Good Manufacturing Practices (GMP) and Good Lab Practices (GLP) drive organizations to have solid document management practices in place.
The Lab Notebook
In the drug discovery process, much of this information lives in bound lab notebooks, second only to the intellectual property stored in the scientist’s head. While scanning technology has not yet progressed to extracting information directly from the human brain, lab notebook scanning is the next best thing.
Scanning lab notebooks simply involves putting the notebook under a specialized book scanner, and imaging every page separately—though it’s labor intensive and familiarity with how to use the technology is key. The book scanner utilizes algorithms to compensate for page curvature inherent to notebooks, to apply image clean-up when needed and include page numbering and other meta data.
Organizations that scan these notebooks gain significant benefits from having this information available electronically in addition to complying with HIPAA and FDA regulations.
First and foremost, it creates a backup copy of the information in the book, reducing corporate risk. There is no need to make photocopies for archiving, which can also be easily lost or destroyed. The information is electronically stored, and can be put into a document retention cycle like any other electronic document.
Second, having this information in a digital format enables quick and efficient retrieval. No longer do you have to manually search through the individual notebooks to find content during an audit. Digital information becomes available quite quickly, and can shorten the retrieval time significantly.
Finally, once scanned, intelligent character recognition (ICR) technology can be used to convert handwriting into a searchable format. This may help the research teams find information from legacy research and development or old drug trials that could lead to new breakthroughs today.
It’s What We Do
American Micro has significant experience helping drug discovery organizations reduce their risk by scanning their lab notebooks. Whether we do the scanning or provide you with the book scanners and image capture software that integrates with your current document management system, we have the critical experience with these technologies to simplify this process.