LABORATORY INFORMATICS
Regulating scientific discovery
SOPHIA KTORI EXPLORES THE USE OF INFORMATICS SOFTWARE IN THE FIRST OF TWO ARTICLES COVERING THE USE OF LABORATORY INFORMATICS SOFTWARE IN REGULATED INDUSTRIES
Most of the issues for regulated industries are centred on how you acquire, manage and store your
data, and knowing what depth and breadth of data may come under regulatory scrutiny from development to manufacturing QA/QC, explains John Gabathuler, director, industrial and environmental, at LabWare. ‘While all laboratories should comply with their own, national and international regulatory standards that are applicable, laboratories operating in regulated sectors may also have to comply with standards such as the ISO 17025 quality management standard, regulatory data integrity guidance’s, and 21 CFR Part 11’ said Gabathuler. The ISO 17025 standard (broadly)
encompasses technical competence, documentation, the control of records and data, and results reporting. Regulatory data integrity applies to systems and processes in the chain of custody of the data, while 21 CFR Part 11 details FDA’s regulations on electronic records and e-signatures. There are many requirements that must be met to achieve compliance, Gabathuler continues. ‘Labs must provide sufficient evidence of adherence to their regulatory procedures. And, critically, they have to
16 Scientific Computing World June/July 2018
demonstrate that the results being put into the system are the true results that were acquired at the point of testing.’ Do this electronically by integrating
your instruments with your laboratory management system – laboratory information management system (LIMS) and electronic laboratory notebook (ELN) – and there is much less opportunity for error. Labs with analysts and technicians inputting data manually will have more processes in place to ensure the integrity of their data, he notes. While it may seem that the topic of
regulatory data integrity has become unavoidable in any discussion on data management, its importance really can’t be overstated, Gabathuler suggests.
Capturing the right data ‘Historically it’s been the QA/QC laboratories’ LIMS that test products going out the door, or laboratories that test the raw materials coming into a manufacturing process, which have been most concerned with regulatory data integrity, but we are now seeing this whole concept driving down into other industries and also into research and development workflows. Audit trails, electronic signatures and laboratory execution functionality are now more common in electronic laboratory notebooks (ELNs) that serve structured and less structured laboratory workflows,’ comments Gabathuler. Everything comes down to the ability
to capture data at source, and to ensure that your data has not been modified, or if it has, that any modification has been assessed by the relevant authorised staff, qualified and approved, he continues. ‘From a compliance standpoint this holds true whether you are in a discovery lab
or a QA/QC lab, and whether you are capturing data automatically from an instrument that interfaces directly with your LIMS, or whether you are capturing or recording data on a mobile device such as a smartphone or tablet.’ Interestingly, most of the regulatory bodies do not provide companies with to-the-letter instructions on how to achieve compliance, Gabathuler notes. Rather, their guidelines and standards expect laboratories to demonstrate sufficient evidence that they have the processes and controls, the required level of validation, and the ongoing risk-based data reviews in place. ‘For a LIMS or ELN system, such as
LabWare LIMS or LabWare ELN, that means building functionality into the system both for direct results capture, and for a full and complete audit trail that encompasses all data input,’ comments Graham Langrish, sales manager for life sciences at LabWare. ‘The idea is that we provide the standard functionality to help customers meet compliance and ensure regulatory data integrity, but at the same time offer the flexibility so that clients can adapt the system to meet their business processes as well,’ adds Gabathuler. A software system designed to help
achieve regulatory compliance in a laboratory should also be versatile to accommodate changes in existing regulations, or to encompass new compliance mandates, Gabathuler continues: ‘Key to that is building a versatile system that won’t become obsolete, or require customisation in the face of new or changing regulations, and that will also allow companies to adapt , as simply as possible, according
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