QA/QC Insight: If it’s on paper…where is it?

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No matter what industry you work in, your laboratory faces some combination of legal, regulatory or corporate requirements to provide secure and on-going access to the data and documents that support your test results.

At any time, a customer audit, a corporate audit, a regulatory investigation or even a legal proceeding, may require that you show on a step-by-step basis how a result was determined and prove that the result you reported is indeed the correct result.  That can be a challenge when your data and supporting documents are on paper.

A study conducted by Price Waterhouse clearly illustrates how difficult that can be.

The study asked a staff of paralegals to search over 10,000 documents, looking for a specific topic, author and date range. Manually searching through paper files took 67 hours (almost 3 days) and turned up 15 documents. The same search, done electronically, found 20 documents in only 4.5 seconds - about as long as it takes to read this sentence.

That points out two critical concerns for every laboratory with paper-based systems:

   1. The amount of time it takes to manually search for documents. When people are waiting for answers you don’t want to keep them waiting while you try to track down a piece of paper.

   2. The likelihood that key documentation may not be found in a manual search. In the study, 25% (5 out of 20) of the documents that met the search criteria were not found in the manual search.

The supporting documentation for even a single sample can include instrument results, calibration information, solution preparation procedures, certificates of analysis for raw materials and more. It isn’t uncommon for the documentation for a single test to run into dozens of pages.

In a paper-based system, accessing those documents can mean having to manually search through forms that have been put away in filing cabinets, stacked in boxes in a storage room or even sent to an offsite storage location. And that needs to be done as quickly and accurately as possible.

In a paperless lab where documents are stored electronically, you can very quickly and accurately identify and retrieve all of the documentation that you need in order to resolve problems or to satisfy auditors and investigators. No more time wasted searching for pieces of paper that you may never find.

For more insight into eliminating the costs and risks of paper based systems in the laboratory, watch our full length presentation “The Paperless Lab – More than a Vision”.