Business requirements Building a Smart Laboratory 2012


• Tere are some changes that mean proof of inventive activities will be especially important for joint research activities. You may also need to improve the retention of other documentation related to Joint Research project;


• Derivation proceedings will 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 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 that it is necessary to start paying attention to their 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. It will therefore be necessary for a laboratory informatics implementation project to very carefully consider the specific requirements of their organisation in this area.[11]


Data integrity


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; • Natural disasters. Tere are many ways to minimise these threats to data integrity. Tese include:


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• Backing up data regularly; • Controlling access to data via security mechanisms;


• Designing user interfaces that prevent the input of invalid data;


• Using error detection and correction soſtware when transmitting data.


Data authenticity


Data authenticity is the term used to reinforce the integrity of electronic data by authenticating authorship by means of electronic signatures and time stamping. 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.’ Generally speaking, they are considered admissible in evidence to assure the integrity and authenticity of electronic records. 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 user name 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.


Data management


Tere are a number of ways that we can assure 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 lab is paramount and must not be compromised. Tis is the ‘quality’ aspect of the quality management system (QMS) that you work under. 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 lab. To help training staff we need to know


the basics of laboratory data integrity and the main criteria are listed below: • Attributable: who acquired the data or performed an action and when?


• Legible: can you read the data and any laboratory notebook entries?


• Contemporaneous: documented at the time of the activity;


• Original: written printout or observation or a certified copy thereof;


• Accurate: no errors or editing without documented amendments;


• Complete: all data including any repeat or reanalysis performed on the sample;


• Consistent: all elements of the chromatographic analysis, such as the sequence of events, follow on and are date- or time-stamped in the expected sequence;


• Enduring: not recorded on the back of envelopes, cigarette packets, Post- It notes or the sleeves of a lab coat, but in laboratory notebooks and/or electronically by the chromatography data system and LIMS used in the lab;


• Available: for review and audit or inspection over the lifetime of the record. Laboratory staff need to understand these criteria and apply them in their


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