LEAN life sciences practices: A macro- and microresponse to document management

By Kim Dyrenius

Life sciences companies are under pressure to cut costs and improve efficiencies across every part of the business. For an industry that is data dependent across the research and development (R&D) and the quality and manufacturing (Q&M) life cycles, cost cutting and efficiency have meant adopting LEAN principles when managing documents.

Traditionally, companies have been paper dependent, sifting through reams of content from preclinical, clinical, safety and labeling organizations; regulatory agencies; manufacturing and marketing firms, and beyond. This has led to large production areas that are bogged down with multiple binders. For example, with Q&M, every change means paper updates and making sure that every person is working from the latest version, is trained, uses the most recent standard operating procedures (SOPs), and that the company is well placed to manage an audit. Every time a document is updated — an almost daily occurrence, particularly in larger plants — these documents need to be switched. Users must also spend countless hours going through binders to ensure that the latest version has been included and must check that no other paper copies have been left lying around.

This is where a shift to LEAN practices comes into its own, for example with the adoption of electronic libraries and a holistic and digital approach to manage documents with electronic collections.

At the same time, regulatory and other professionals are pushing for solutions that are adaptable to the modern workplace. They want to ensure that there are no bottlenecks in the workflow, which means they need mobile capabilities with their document management solutions that allow them to open, read and sign documents on the go in a secure and compliant way.

Eye in the sky

These macrolevel issues go hand-in-glove with the microproblems regulatory and other departments face daily when it comes to documentation. When a printed copy is needed, users need to be sure those documents don’t get in the wrong hands, that the copies are controlled, issued to the right area of use, and that the latest version is being used.

When paper is used, a process needs to be in place to ensure not only that the correct version is used but that old documents and versions are destroyed.

A common issue during an audit is that the wrong documents are being used, which can be attributed to people not being trained on the latest documents or not having access to the most current version.

Best practices in document management have ensured that both the macro issues and the micro concerns companies face can be handled by next-generation digital capabilities. For example, during an audit, QR codes can be quickly scanned to make it easy to pull up the latest document or have access to the latest document versions via an electronic document library or document collection.

Another best practice is the adoption of training workflows which ensure that users are trained on the latest documents, that they read and absorb them, and then sign to acknowledge that they have followed the required steps. This provides a clear audit trail, since users and inspectors will know exactly who has been trained in the latest documents. When a document is updated, a prompt provides a reminder that users need to be trained on the new version.

Increasingly, life sciences companies expect to be able to take advantage of digital innovations, mobility and LEAN practices. Industry leaders will look to deploy technology that enables them to be nimble, respond to new regulations globally and improve business efficiencies while cutting costs, all the while remaining compliant with regulatory guidelines.


By Kim Dyrenius, Solution Specialist, DXC

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