Laboratory notebooks provide important legal information as well as scientific or engineering data. Lab notebooks may contain evidence related to priority of patent claims, as well as verification of compliance with FDA guidelines for good laboratory practices (GLPs) and good manufacturing procedures (GMPs). Electronic lab notebooks are not always acceptable in legal proceedings as a substitute for original, permanently-bound, handwritten records, particularly with respect to proving dates of invention in patent cases. Until electronic lab notebooks are fully approved by the courts, a hard copy of all data should be maintained. Following are guidelines to consider if you maintain electronic versions of laboratory notebooks.
#1 - Do adopt a written policy for electronic record-keeping
Establish a written policy that is furnished to each employee and adopt the policy as part of your normal business routine. Review compliance periodically with employees.
#2 - Do retain permanent back-up copies
Back-up all electronic data to a clearly labeled "write once" media. Store the back-up copy in a safe place free from magnetic fields or other corruptive conditions. Print computer generated data to paper and label, sign (with a witness), and date the hard copy and permanently attach the hard copy to the handwritten notebook. Reference all electronic data in the handwritten notebook. Store the hard and soft copies with a record custodian who can vouch for their integrity. Maintain all records/data for the duration of your established document retention period.
#3 - Do maintain computer system integrity
Computer systems should be regularly validated to ensure reliability, accuracy, and consistent performance. Precautions should be taken against the importation of viruses.
#4 - Don't allow electronic records to be modified
Hardware and/or software should be developed or used which prevents the ability of editing original research descriptions, i.e., WORM - Write Once, Read Many times. Additionally, all electronic records should be time-stamped by a separate server having highly restricted access.
#5 - Don't allow unauthorized computer access
Prevent unauthorized access to your computer system. Use key and screen locks, as well as removable storage devices that can be locked away when not in use. Electronic/digital signature or encryption hardware and/or software will enhance the credibility of the electronic records. Limit access to the computer system to authorized personnel who have a genuine need for access. Limit distribution and use of information stored in the system. Frequently change individual user codes and passwords used to log on to the system and delete user codes when employees leave. Require periodic reports on who has accessed the system, and review the reports for any unauthorized persons.
By Diane L. Gardner - gardner@fr.com
Reprinted by permission of Fish & Richardson P.C.
© Copyright 2000 Fish & Richardson P.C. All rights reserved.
