Data integrity takes centre stage

Te smart laboratory can help maintain data integrity. But, as Isabel Muñoz- Willery and Roberto Castelnovo of the consultancy NL42 discuss, the place to start is with an organisation’s business needs, not the technology and informatics tools themselves

As Peter Boogaard highlighted in the most recent edition of Scientific Computing World’s Laboratory Informatics Guide, ‘data integrity’ is the key concept in the laboratory. Te regulatory authorities’ concerns over the integrity of laboratory data have finally set a deadline for the pharmaceutical companies to be completely compliant. Te paperless, smart laboratory is no longer an abstract fantasy, but is urgently needed as the best way to conform with these regulatory requirements. Data integrity covers the whole product

life-cycle and a variety of organisations have put together educational and training activities across Europe to address this issue. Te US Food and Drug Administration (FDA) is in the lead for many opportunities


to attend training remotely. Te FDA’s Office of Manufacturing and Product Quality (OMPQ ) recognises the effort invested in training inspectors to detect signs of data management problems, and of altered or manipulated records. It has already shown readiness on informatics technologies and raised the bar in the understanding of data integration capabilities available today.

Pay attention to the design, not the tools

Regulatory authorities are finding more issues with data integrity than ever before. It is important to reduce the risk that the integrity of laboratory data might be compromised, by ensuring that controls are correctly implemented and appropriately managed throughout the entire life of a record. Ensuring strong data integrity requires attention to the design, operation, and monitoring of processes and systems involved. Once again, we´re glad to contribute

to this year’s edition of Building a Smart Laboratory drawing on our knowledge of dynamics of laboratory informatics in Europe – and more specifically in South Europe. While our article in BASL 2015 more concretely described the dynamics of the Spanish economy, the different pharmaceutical companies’ categories, and the relevance of cultural differences for international providers, this time we´d like to highlight the opportunities to implement a transformational change, revisiting

“Many companies are now emerging with new, cloud- based products”

existing processes, finding potential gaps in data integrity and introducing a higher level of automation. Let’s start by defining the processes

required to ensure the integrity of the data. Data integrity is the assurance that data records are accurate, complete, and intact. Ensuring data integrity means protecting


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