Building a Smart Laboratory 2017

Beyond the laboratory reanalysis performed on the sample;

l 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?

l 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

l 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 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

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. Te main criteria are listed below:

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

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

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

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

l Accurate – no errors or editing without documented amendments;

l Complete – all data including any repeat or

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 that data integrity and data authenticity can be guaranteed in a digital world. Lawyers and patent attorneys need to be confident that electronic lab notebooks can be presented as evidence in patent submissions, interferences and litigation. n


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