The client develops and manufactures pharmaceutical products for a wide range of medical disciplines. Specifically, the Vaccine Research and Development group is responsible for the development of therapeutic vaccines. The company engaged Clarkston Consulting to support and deploy capabilities to allow paperless processes by transforming manual operating procedures supported to fully capable electronic laboratory information management system (LIMS) processes.

The primary goal was the business adoption and transformation to a digital process with complete elimination of physical forms and data packages. Data packages were previously made up of hundreds of paper forms and standard operating procedures (SOPs). Due to an increasing number of studies, samples, and assays, the continued maintenance and operation costs of paper processes were unsustainable.

Clarkston worked with the client to transform the operational processes dependent on paper workflows into LIMS “totally paperless” processes. The project included training and change management to deploy and assist with end-user adoption. The solution provided improved data quality and security, the ability to automate data validation, lowered operation costs, and enabled real-time analytics. The lab operations are now totally digital – and totally paperless.

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Clarkston and the client primarily set out to achieve business digital transformation to operations to go paperless and improve process efficiency by eliminating physical data packages and other associated forms. The goal was to simplify data collection and analysis, in turn reducing data entry errors by developing automatic data validation checks which are possible by the action to go paperless. By implementing process change it would increase functionality to allow for greater system utilization.

The resolution of this project with Clarkston Consulting and the client included using teams focused on individual business processes to analyze and convert paper forms into electronic workflows within LIMS to effect operational change in the action to go paperless. The team configured workflows that leveraged LIMS functionality, including test calculations, data validation, and analytical reporting to perform lab processes that were previously performed manually. The team also implemented and validated the developed workflows using agile and iterative cycles of design.

Some of the key benefits of this project included digital standardization of process flow, data collection, and analytical reporting within LIMS and “go paperless” method. Simplified lab processes by reducing effort involved in creating and managing data packages and paper forms were also recognized, in addition to improved data security gained by converting paperwork into electronic forms within an access-restricted system. To read more about the other key benefits and resolutions of this client project with Clarkston, download the full case study below.

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Contributions by Brandon Hocker.