Why an ELN offers Superior IP Protection
ELNs offer superior intellectual capital protection through mitigation of data loss because of the electronic nature inherent to an ELN. IT departments backup the ELN into data archives, usually with redundant copies secured off-campus.
Because experimental data is controlled and held electronically:
- Electronic records are not subject to either environmental or human hazards, such as acid spills or worse yet, a fire in the laboratory.
- The ELN is permission-based, assuring only those with proper authority have access to the information.
- Because of inevitable employee attrition, the organization can be assured that the investment in work product remains with the organization when employees leave. If a copy of the ELN were to made by a departing employee, the audit trail capability previously discussed could flag the organization warning of a possible breach of data security.
- The ELN provides consistency between notebook entries and notebooks themselves, assuring the cleanliness and integrity of the experimental data.
- Electronic signatures, time/date stamping and comprehensive audit trails insure the indisputable authenticity of the work product and adherence to 21CFR Part 11 & GxP by answering the questions of: a) who created the record; b) when was the record created; c) what has been changed (between versions); d) why it was changed (through annotation); and, e) whether the work product can be reproduced.
Electronic records are now explicitly classified as having the same weight as paper records in both Patent Application and Interference cases, pursuant to 37 CFR 1.671.
