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Team Talk

Challenges with Documenting GMP Sample Preparation

LabTwin Team
LabTwin Team September 29, 2020

Poor quality samples lead to poor quality assay results. Therefore, sample collection and preparation methods are a critical part of Good Manufacturing Practice (GMP). Documentation and data integrity are also essential components of GMP. Data integrity, as defined by regulatory agencies such as the U.S Food and Drug Administration (FDA), means data must be complete, original, accurate, contemporaneous and attributable.

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However, it is impossible for a scientist to fully concentrate on sample preparation and, at the same time, make a complete and accurate record of everything they did to prepare that sample. This is especially true for complicated sample preparation protocols where the end product is prone to degradation, such as RNA extraction.

 

Technicians must wear gloves to protect themselves and the sample from contamination. Work with potentially infectious material must also take place in a biosafety cabinet. All these factors make it difficult to generate contemporaneous, accurate and complete records of GMP activities.

 

Technicians may have to leave their samples on the bench and remove their gloves in order to record data on paper, or enter data into a manufacturing execution system (MES) or Laboratory Information Management System (LIMS). MES and LIMS are often on computers located away from the bench. This disconnect can significantly disrupt workflow during sample preparation, compromising the quality of both the sample and associated data.

 

If scientists choose instead to complete sample preparation and then update records at a later time, the data is no longer contemporaneous.

 

With voice-activated digital lab assistants, technicians can follow protocols, make notes and collect data while they work at the bench. Digital lab assistants make it possible to create truly contemporaneous, complete, accurate and original records during GMP manufacturing. Technicians can concentrate on their work, knowing their voice notes are automatically digitized and attributed with user identification and time and date stamps.

 

In the Lab of the Future, digital assistants will also connect with all lab instruments and automatically note critical metadata including lab temperature and humidity, and reagent identification, weights and batch numbers. This will allow technicians and managers to monitor how conditions affect sample and product quality.

 

To learn more about how voice-activated digital lab assistants can overcome documentation challenges in GMP environments, read this white paper.

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