For companies that deal with issues of compliance and independent testing, data integrity has been a significant topic for a while now. Pharmaceutical manufacturers are under a huge burden to not only produce safe, effective products for the market, but also to prove that the data used is sound, unaltered, and protected against possible corruption.
The FDA does not, as an organization, personally test products or devices to demonstrate safety and efficacy. Rather, the FDA relies on third-party testing labs, like us, to provide critical data sets. That begs the bigger question: how can the FDA be sure those data sets are reliable–and have integrity?
The reliability of data addresses the ability of a lab to generate valid results.
The integrity of data addresses the data being raw and unmanipulated, after it is produced.
Since the pen-and-paper era of scientific inquiry, the FDA has always expected data integrity; Code 211.68 from the Code of Federal Regulations lays out the guiding principles of data integrity, requiring that all data is exact, secure, and cannot be altered, erased, or lost accidentally. More digital data means the FDA must set clearer expectations and boundaries surrounding which practices do and do not support data integrity.
Gavin Smith, one of our lead scientists, is always considering how data integrity compliance ensures that Polymer Solutions’ analyses are trustworthy and effective. When we asked him about data integrity, he got right to the point. “With our compliance strategies in place, our data will be viewed as more reliable than other labs that don’t have these strategies in place.”
The world of data integrity encompasses so much of what’s integral to what we do here in our analytical and legal testing labs. Without a strong core and commitment to this complex issue, our testing labs would not be able to offer industry-leading and cutting edge testing resources.
Our CEO, Cynthia Rancourt, said on the subject: “Data integrity is part of the Great Science that all team members embrace at PSI.” PSI’s focus on continuous improvement is a huge part of the compliance strategy in place since long before we formally wrote our data integrity policy. It is this focus that helps PSI stay current with good manufacturing practices! Along with ensuring compliance to the standards our clients need, data integrity supports the great science that will stand the tests of scrutiny, oversight, and further analysis.
Our passion and dedication to compliance makes our testing labs a superior choice for clients working within these strict compliance guidelines every day. From the start of testing through delivery of results, we set our clients and scientists up for success with our FDA-sanctioned data compliance policies.