It’s all about quality: How to validate data migrations in the life sciences industry

Colleague | migration-center Team

migration-center team

September  14, 2022

Working processes in the life sciences and pharmaceutical industries are controlled by strict quality and security regulations. The comprehensive regulatory requirements also apply when migrating data during the implementation of new IT applications or the consolidation of different systems after mergers and acquisitions. The question is: how can life sciences companies meet compliance guidelines and manage the quality of their data in the context of content migrations?

To answer this question, we talked to the Vice President of Migration Services at fme US, Wesley White, who has in-depth expertise in data migration projects in life sciences for the past 20+ years.

Colleague | Wesley White

Wesley White – Vice President of Migration Services at fme US

We already mentioned the sensitive framework of the life sciences industry within the interview of Florian Piaszyk-Hensen. Nonetheless, why would you say content migration projects are worth the effort?

Wesley White: They are not only worth the effort but are generally a required activity. This requirement is founded, not only on the fact that in a merger or acquisition position but also compliance with the new systems of record of the company. The data points are completely different regarding available document types and attributes from the source environment.

So, it becomes a natural requirement to facilitate a migration project to get this content from the source environment to the new target environment. By providing the capability of migrating the other systems data, through transformation and updated business rules, you allow the opportunity to allow the usage of this content in the new system of record.

This also has the benefit of not managing more than a single system for the same purpose and has a number of other benefits for a company.

That sounds like a promising opportunity. In life sciences data might influence product quality and thereby the patient’s safety. To perform a successful data migration and ensure an error-free data quality, a crucial step is verifying the accuracy of the migration. Could you elaborate a little bit more on the data validation process?

Wesley White: The data verification process can be complex, but with a solid methodology the process can be simplified regarding expectations of results. As part of our methodology, we ensure that there are various stepping points to make sure that the validation of the output from our migration toolset is done as expected. We do this by:

  1. Having the appropriate test scripts that are executed against the mappings which ensure the output is as expected by the approved mappings in hand.
  2. In addition, we provide a component of a visual inspection of the content as part of the script execution.
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ANSI standard approach

The visual inspection provides additional confirmation as we utilize an ANSI standard approach based on the volume of content in scope. This way, we can prove that what we see is within the acceptance ratios provided by the ANSI standard. It also allows us to record a like – for – like comparison between the source and target documents, renditions and attributes. This level of review provides the confidence our clients need that the migration output was done correctly and as expected.

Once the script/verification effort is completed we wrap up our findings in a summary report which allows us to track how many documents were migrated, how many errors, and if there are any errors; the steps that were taken to address those errors. The method in which we address the errors is the key to providing a solid validation approach as well.

If errors arise from the migration, we have a deviation process that allows us to:

  1. identify the error
  2. identify the documents affected
  3. provide a mitigation path
  4. and ultimately correct the error through migrating the errored content again

This allows a complete end to end verification and mitigation process to validating our content and allows for the highest level of success and confidence when performing migrations.

Even in case of a thoroughly prepared project planning and execution, there certainly are misjudged project aspects. According to your experience, why do migration projects of life sciences companies sometimes fail?

Wesley White: While I wouldn’t necessarily call it a failure, as there is always a road to success, some migration projects do introduce their own complexities which can lead to some failures. As stated previously, a component of our migration methodology allows us to identify the document failures and mitigate the reasons for them through analysis, updates to mappings, updates to rules, and ultimately re-migration of the content which experienced the issues.

This solidifies the capability to successfully migrate content although there are initial failures. Allowing our clients, the piece of mind that their content has made its journey to the new target successfully.