The ability to store and sort large amounts of data makes electronic notebooks very appealing. They have been slow to be accepted as standard because of security issues. How can you guarantee the data is original and has not been compromised? Improvements in technology are addressing these issues but most institutions are still requiring paper records. Many researchers use a combination of electronic and paper records.
• FDA published rules for acceptance of electronic documents in March 1997 Title 21 of the Code of Federal Regulations, part II (The FDA' current thinking on the issue is available online at http://www.fda.gov/cder/guidance/5667fnl.htm)
• Few ELNs have been subjected to legal scrutiny.
• Doubtful that many would pass the test
• Most researchers in academia still using paper records
Requirements of a Data Management System
• Ability to sort and search
• Consistency of use throughout the lab
• Ability to update records
• Must have appropriate data entry for all the sort criterion
• Have a standardized document naming protocol
• A system for logging in reagents
Assign responsibility
• Assign a designated individual to ensure that data management plan is executed
• Write and implement Quality Assurance procedures
• Include scheduled spot checks
• Communicate responsibilities to all personnel
• Decide what to store
• Printed records
• Electronic records
• Lab protocols
• Reagents
• Instrument histories
• Decide where to store it
• Specify how to do it
• Assign who will log the information
Finding the right data management system/laboratory information management systems
Systems are being developed and improved regularly. Research done just before a purchase will yield the most up-to-date information on currently available software. Some points to consider as you make your decision:
• Is it compatible with your existing software?
• Are other users satisfied?
• Is there available system support?
• How flexible is the system?
• Does the system configuration meet your needs?
• What is the required training?
• How stable is the company selling the system?
• Is it worth it?
• Resource