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QMS

Still relying on spreadsheets for quality management?

By QEdge Team  Published On October 5, 2016

Pharmaceutical, Life science and healthcare are few of the industries need to pass under shrewd scanner of various quality and regulatory authorities like USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India). As these industries are delivering products to enhance the level of health of mankind, hence need to ensure the efficacy, safety and quality of their products. So the importance of having digital quality management system and training management system is very high. FDA has defined Current Good Manufacturing Practices (cGMP) for these above mentioned industries as a disciplinary guide line to produce superior quality of products.

But still most of the companies relying on hybrid methods like using spreadsheets for complaint, deviation, CAPA, OOS & OOT, audit and training management. Spreadsheets are the most cost effective solution and you can do plenty of things in that but when there is a question comes about data integrity, transparency and control, it has failed to deliver.

Here are the complexities associated with Spreadsheets:

  • Error prone system
  • Required lot of time, cost and effort
  • Data available in different silos
  • Enhance the non-compliance instances
  • Unable to provide the centralized view to the management
  • Unable to send notifications and reminders
  • Unable to produce dynamic reports
  • Unable to design required workflow
  • Unable to provide information on the go
  • Unable to provide prevention in case of duplicate entry

The good news is that technology now enable companies to take advantage of digital quality management Systems to perform tasks without relying on spreadsheets and greatly reduces the potential for mistakes. Do you handle sensitive data? What would happen if you lost critical information on a spreadsheet and what would the cost be to your company?

The true cost goes far beyond the initial purchase price of an Excel-based system. This is because companies reuse spreadsheets from year to year and 90% of them have errors (Coopers & Lybrand study). These errors can jeopardize an entire organization’s reputation and hidden errors and inaccuracies can also lead to very bad decision-making.

Edge out the paper based quality management hassles with QEdge by Sarjen Systems.


What does a modern pharmaceutical quality management system look like
Still addressing out of specification/out of trend (OOS and OOT) manually?
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