Data management in life sciences is a big task: not only does your team have to make sure the right data is generated, but also that it remains accurate and consistent. Robust compliance software tools can help your team bolster data integrity, provided they have the right features. There are four key data integrity features in particular that your organization should look for in any compliance software tool.
Globalization has empowered organizations to obtain and collaborate with talent around the world when formulating new and innovative life science products. However, this presents a major challenge to data integrity: with multiple remote teams generating and passing project information back and forth, the risk of data being compromised or lost increases. Plus, some sites can inadvertently silo information away, resulting in rework or other product design issues.
One drawback with database centralization is not having multiple repositories for information; with all of your product information stored within a unified cloud infrastructure, the records are not spread out across your sites. As a result, the risk of catastrophic data loss can increase. It’s therefore important to find a vendor that applies a risk management framework to data integrity and has controls in place to mitigate any of these issues. In particular, you want to make sure the compliance software tool vendor applies industry best practices for data storage safety and integrity, such as:
Leveraging audit trails, your team can see all the changes and touches to data authored and retained within the tool’s centralized database. In the event of later-stage issues, root causes can be quickly identified and controlled. In addition, audit trails can show who has altered or changed data, improving accountability and transparency.
With traceability incorporated into the compliance software tool your team uses, they can use the feature to link project data between and within requirements levels from across design stages. Viewing these linkages and analyzing data integrity issues for their impact is simpler, as well as the resulting control activities. As a result, resources utilized in remediation can be optimized, saving critical time and effort.
One of the biggest pain points of data integrity is access—who is allowed to author, alter, remove, or otherwise touch product information. When manually managing data in documents, this access is hard to control. More data access means a higher chance of human error.
Compliance software that has all these features built in is crucial to managing the integrity of your life science product’s data. Especially as the industry moves from document-centric to data-centric modes of development, having all the tools at your disposal to manage your product information will be highly beneficial in the years to come.