Building a Smart Laboratory 2018


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: n Reliability – the content must be trusted as accurate;


n 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;


n Integrity – must be complete and unaltered, physically and logically intact; and


n 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 ensure the integrity and authenticity of electronic


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There is a growing level of interest in how consumer technologies can enhance the user experience of working with laboratory informatics tools


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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. Te main criteria are listed below:


n Attributable – who acquired the data or performed an action, and when?


n Legible – can you read the data and any laboratory notebook entries?


n Contemporaneous – was it documented at the time of the activity?


n Original – is it a written printout or observation or a certified copy thereof?


n Accurate – no errors or editing without documented amendments;


n Complete – all data including any repeat or reanalysis performed on the sample;


n Consistent – do all elements of the chromatographic analysis, such as the sequence of events, follow on and are they date- or time-stamped in expected sequence?


paper, hybrid systems or fully electronic systems. To support the human work, we also need to provide automation in the form of integrated laboratory instrumentation with data handling systems and laboratory information management systems (LIMS) as necessary. In any laboratory, this integration needs to include effective audit trails to help maintain data integrity and monitor changes to data. Supervisors and quality personnel need to


monitor these audit trails to assess the quality of data being produced in a laboratory – if necessary a key performance indicator (KPI) or measurable metric could be produced.


Chapter summary


From a broader business perspective, the introduction of computerised tools for managing laboratory information comes at a perceived higher cost, and challenges the user to consider very carefully the consequences of moving from a paper-based existence to one based on technology. Te return on investment equation is


critical in obtaining the initial go-ahead for an informatics project, but the transition to digital from paper represents a major upheaval to long-established and well- understood information management processes. Computer systems used in regulated


environments need to be validated; the user needs to be confident that computerised systems can deliver productivity benefits, and data integrity and data authenticity can be guaranteed in a digital world. Lawyers and patent attorneys need


to be confident electronic lab notebooks can be presented as evidence in patent submissions, interferences and litigation. n


35


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


Beyond the laboratory


n Enduring – they must not be recorded on the back of envelopes, cigarette packets, or the sleeves of a laboratory coat but in laboratory note books and/or electronically by the chromatography data system and LIMS; and


n Available – for review and audit or inspection over the lifetime of the record.


It is important that laboratory staff understand these criteria and apply them in their respective analytical methods regardless of working on


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