IDBS Blog | 21st February 2017

Increasing Data Quality through Traceability

When R&D data is managed in silos, it’s inevitable that transcription errors and inaccuracies will occur especially when moving data between systems, people and organizations.

The problems seem obvious, don’t they?

When data is spread across multiple systems, the ability to trace the source information is dramatically compromised, making it difficult to even identify if, and when, critical information is missing. This can result in lengthy investigations towards the end of the development process, often taking months to complete and requiring key experiments to be repeated to fill the gaps.

Investigations, in turn, divert the attention of development teams – reducing their capacity to work on other development projects resulting in a detrimental impact on the entire R&D pipeline.

There are other issues too. Silos introduce redundancy, meaning the same information is often stored in at least two, or more, separate places. In instances where this information is conflicting, it’s usually unclear which version is correct.

An Integrated Development Platform could put an end to these headaches, by increasing the traceability of both information and materials.

By maintaining linkages between preparation, processing and use, a data management platform can automatically create a searchable genealogy. The details of all processing steps can be recorded in the same system, making it possible to track the progress of material from one unit operation to another.

This also aids troubleshooting. If an issue is identified with a particular lot of drug or excipient, formulators can rapidly determine where it has been used and identify all formulation batches that are affected.

One platform, one single point of truth

Problems can be identified faster and the inherent traceability of information makes it possible to identify potential problems, such as an issue related to a change of supplier that may affect other ongoing studies, proactively correcting or terminating them, potentially saving $10,000s in re-work and development delays.

That’s not all. Applying the auditing requirements of good manufacturing practice (GMP) throughout the development process also ensures traceability and helps facilitate regulatory inspections.

It seems so simple: having all your data in one place guarantees both data integrity, completeness and traceability.

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