Biomedical Engineering Reference
In-Depth Information
and normally hearsay is not admissible as evidence. FRE 802 [9] covers this
situation. It states that “hearsay is not admissible except as provided by these
rules,” and hearsay is defi ned as “a statement other than one made by a declar-
ant while testifying in court, offered in evidence to prove the truth of a matter
asserted ” (FRE 801) [10] .
Companies must put in place a foundation that supports the electronic
records in an ELN. ELN vendors can assist in the process by including auditing
functionality, but the fi nal responsibility lies with the company implementing
the ELN. The foundation must include the following policies known to the
relevant employees:
Record activities as part of their normal course of duties.
Make the record at or near the time of the activity.
Create and maintain the records according to company policies.
The consequences of not having adequate procedures can be dire. In
Chen
(BMS) v. Bouchard (RPR) Interference No. 103,675
[11] the following was
decided: “Thus, we [the court] simply do not have adequate information on
which to fi nd that Ms. Wei's laboratory notebooks were 'kept in the course of
regularly conducted business activity, and if it was the regular practice of
[BMS] to make the [record].' ” Consequently the patent was declared invalid.
Companies must also establish a custodian for the electronic records; this
person will normally present the evidence in court and establish the business
exception to the hearsay rule described above.
The records must be in human-readable form and be maintained using
industry standards for records management. It is also advisable to test the
security of the system using ethical hacking procedures.
Once IP protection was no longer an issue, ELNs began to evolve into a
wider solution (see Fig. 19.2 ).
19.3
CENTERPIECE OF SCIENTIST ' S DESKTOP
An ELN can be workfl ow specifi c, for example, supporting medicinal chemists
who produce new chemical entities, or more generic, where a framework pro-
vides for the secure, audited capture of information. Many organizations use
Microsoft Word or Excel to capture the information and tie them to a docu-
ment management system, such as Documentum, to provide security. If the
information to be captured is extremely unstructured, this can be suffi cient, but
if there are structured elements, for example, repetitive calculations, then struc-
ture around the repetitive tasks is desired by the users. Adoption by academic
scientists has been low, but academic institutes are now very aware of the value
of IP and seek to capture it securely so that it can be commercialized.
If a dedicated ELN solution is adopted by the organization, then it becomes
an agent for change. The ELN then becomes the central application that the
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