Building a Smart Laboratory 2018 coded to suit the business processes.


n Example: it varies, but includes all internally/ externally developed IT applications, custom firmware and spreadsheet macros. Parts of Category 4 systems may be in this category.


n Validation: the same as Category 4, plus more rigorous supplier assessment/audit, full life cycle documentation, design and source code review.


brief test will show that the system is up and running.


System validation


Te validation itself usually needs to be divided into more manageable pieces. One way is to use the ‘4Q method’. Tis comprises development qualification (DQ), installation qualification (IQ), operation qualification (OQ), and performance/process qualification (PQ). What the chosen manageable pieces or phases are is up to the individual, but it must be described in the validation plan. Tis defines the phases, the input and output of the phases, and which documents will be created during the phases. Typically, this will be a phase plan including test plans, the testing itself and the test documentation, and the phase report.


DQ – development qualification Tis includes writing the user requirements specification, choosing the system, auditing the supplier if the risk assessment says that this is needed, and implementing the system.


IQ – Installation qualification Installing the system is usually just a matter of following the description from the supplier. A


OQ – Operation qualification Tis may be defined differently in different organisations, but a common definition is to test each function separately. Tis is oſten what the supplier already has done, so the user may not have to do this if documentation and/or a supplier audit has shown that this has been done.


PQ – Performance or process qualification Te PQ is also defined differently in different organisations. Basically, the PQ is testing that the implemented system is according to business processes. Tis includes indirectly testing that the separate functions work as intended. Tis may also be called the system testing. If the supplier’s OQ testing is unavailable,


more of the functions may have to be included in testing. It is perfectly fine to combine the OQ and PQ into one combined phase. It is important to qualify or validate all the


functions needed for your workflows. A thorough description of IT validation


can be found in the book, International IT Regulations and Compliance. Tis book also has chapters on LIMS and instrument systems, and the tips there are useful to read and follow in


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


“


order to get a really smart laboratory with the information required. But validation is never done. It’s important


to prove that the system is still validated, even aſter changes in and around the system. Having appropriate procedures to explain how to keep the validated state, and documentation to prove that procedures have been followed, are a must. Tese procedures need to cover whatever is


appropriate, including: n Error handling, including corrective action and preventive action;


n Change management; n Validation/qualification of changes; n Backup and recovery; n Configuration management; n Disaster recovery and business continuity; n E-signatures; n Environmental conditions; n Risk assessment and management; n Security and user access; n Service level agreements; n System description; n Training; n Validation and qualification; n Supplier audit; n Daily use; n Implementation of data in the system; n Qualification/validation of implemented data in the system; and


FIG 6 System costs of paper notebooks and ELNs Paper Electronic


Patent-related issues Te US patent system is based on ‘First to


Number of users www.scientific-computing.com/BASL2018


Invent’ and, in order to help determine who was first to invent, most companies engaged in scientific research create and preserve evidence that they can use to defend their patents at a future date. Traditionally, this evidence has been in the form of the bound paper laboratory notebook. In a patent dispute, any inventor is assumed to have an interest in the outcome of the case, so their testimony must


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n Data transfer between systems. Some of these SOPs will be generic in the organisation, and some will be system specific. Validation is a never-ending job, but with a


validated system the user can be sure that the system works as intended and that the data is secured inside the system. Tat means that the user can prove beyond doubt that the data was entered on a given date and that the system will show that data has been corrected later.


Beyond the laboratory


System cost


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