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Data governance and data integrity

Companies that excel at using their data as an asset to boost their competitiveness in a global market have recognised that their Quality System (QS) provide more than a regulatory requirement check box and data integrity is key. In fact, you can improve operational efficiency through collection and analysis to make informed decisions about which business processes to improve, as Deming said, “In God we trust, all others must bring data.” Good data governance enables these organisations to rely on their Quality system, with procedures and policies in place to ensure their data & information assets are available, usable, secure and have demonstrable integrity.

Benefits of good data governance

  • Better decision making
  • Transparency into processes
  • Reduce operating costs
  • Improved strategic planning
  • Reduced risk of data loss and corruption

Data Integrity is fundamentally a design problem; but is should be noted that electronic systems are not inherently safer or at lower risk compared to manual or paper based systems, without proper controls and well thought out governance structures the end results can be significant costs to your business and impacts to the long term success of your processes. From the ‘MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015′

“Manufacturers and analytical laboratories should be aware that reverting from automated / computerised to manual / paper-based systems will not in itself remove the need for data integrity controls.”

The purpose of this blog series is to discuss critical design decisions when building Quality Processes, with a focus on Microsoft technology as the platform. Primarily we will use SharePoint as the user interface, SharePoint provides a simple, low cost environment that is highly customisable to meet the requirements of the most demanding manufacturing environments. The support of Microsoft to further the development of these applications is large incentive to invest in the long term outcomes, and with a global developer base already available the risk of being left with a ‘niche’ solution that is cost prohibitive to develop for is removed.