Beyond the laboratory Building a Smart Laboratory 2015
organisation to increased risk, due to the need to maintain the integrity of each system, and the consistency of the content between them. Similarly, the use of generic systems for such a task can increase discovery concerns and also increase the likelihood of problems. Further guidance should be sought from records management personnel and legal advisors within the organisation, in order to determine policy. A recommended approach to help
uncover and resolve legal/patent concerns is to work with the company’s lawyers and patent attorneys to simulate the presentation of ELN evidence in the courtroom, and then work back to the creation of that evidence in the laboratory.
The America Invents Act – implications
Patent-reform legislation, in the form of the Leahy-Smith America Invents Act 2011, changed the US system from First to Invent to First to File in March 2013. It is very tempting to view this change as an opportunity to relax some of the procedural requirements of ELNs used in research laboratories. However, there are clauses in the Act
that would suggest it’s wise not to make such an assumption. It is likely that patent interferences and interfering patent actions will continue for many years for patents and applications filed aſter March 2013. [13]
“ Data integrity, in a general sense, means that data cannot be created,
changed, or deleted without authorisation”
Tere are specific circumstances described
in the America Invents Act that, for example, require proof of inventive activities to remove prior art for joint research activities, or to preserve the right to an interference if the application contains, or contained at any time, a claim to an invention filed before March 2013. Until the act becomes effective, and there is clarification about the implications of the new legislation, there is no reason to change in-house procedures for keeping laboratory notebooks, or for vendors to revise the procedures and workflows in their ELN products. Te more immediate concerns are:
32
• Tere is a loophole that will allow people to prosecute a patent under the old First to Invent rules for many years to come. First to File isn’t dead even aſter 16 March 2013 – there are some changes that mean proof of inventive activities will be especially important for joint research activities. Te retention of other documentation related to joint research projects may need to improve; and
• Derivation proceedings will also require proof of inventorship.
To add further uncertainty, there’s always a chance (or indeed probability) that things are going to end up in the US Supreme Court to examine the constitutional implications of a move away from First to Invent. So it does appear that the new Act makes legally robust, signed, and witnessed records of inventive activities (generally in the form of lab notebooks) even more critical. With a move to ‘First to File’ there’s the additional pressure of getting to the Patent Office quickly, which means it is necessary to start paying attention to the patent filing process, which has historically not been under much time pressure.
Data integrity, authenticity and management
Whenever electronic records are used within the framework of legal or regulatory compliance, data integrity and data authenticity are fundamental requirements of the computer systems used to create, manipulate, store and transmit those records. Tese requirements may also apply to in- house intellectual property (IP) protection requirements. It will therefore be necessary for a laboratory informatics implementation project to very carefully consider the specific requirements of their organisation in this area.[14] Te characteristics of trustworthy
electronic records are: • Reliability – the content must be trusted as accurate;
• Authenticity – records must be proven to be what they purport to be, and were created and transmitted by the person who purports to have created and transmitted them;
• Integrity – must be complete and unaltered, physically and logically intact; and
• Usability – must be easily located, retrieved presented and interpreted.
Data integrity, in a general sense, means
that data cannot be created, changed, or deleted without authorisation. Put simply, data integrity is the assurance that data is consistent, correct and accessible. Data integrity can be compromised in a number of ways – human error during data entry, errors that occur when data is transmitted from one system to another, soſtware bugs or viruses, hardware malfunctions, and natural disasters. Tere are many ways to minimise these threats to data integrity including backing up data regularly, controlling access to data via security mechanisms, designing user interfaces that prevent the input of invalid data, and using error detection and correction soſtware when transmitting data. Data authenticity is the term used to
reinforce the integrity of electronic data by authenticating authorship by means of electronic signatures and time stamping. Generally speaking, electronic signatures are considered admissible in evidence to en sure the integrity and authenticity of electronic records. An electronic signature is a generic term used to indicate ‘an electronic sound, symbol or process attached to or logically associated with a record, and executed or adopted by a person with the intent to sign the record.’ A digital signature is a specific sub-
set of an electronic signature that uses a cryptographic technique to confirm the identity of the author, based on a username and password and the time at which the record was signed. Te requirements for an informatics project will be somewhat dependent on the nature of the organisation’s business and internal requirements, but security, access control and electronic signatures are factors that must be given appropriate consideration. Tere are a number of ways to ensure
data integrity and authenticity. Te first is to develop clear, written policies and procedures of what is expected when work is carried out in any laboratory; the integrity of the data generated in the laboratory is paramount and must not be compromised. Tis is the ‘quality’ aspect of the quality management system (QMS) that must be followed. Tere is the parallel need to provide
initial and ongoing training in this area. Te training should start when somebody new joins the laboratory, and should continue as part of the individual’s ongoing training over the course of their career with the laboratory. To help train staff, we need to know the basics of laboratory data integrity.
www.scientific-computing.com/BASL2015
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44