Data integrity is critical to the regulated life sciences industry.  The FDA has increasingly focused on the topic, and many recent warning letters posted to the FDA website mention data integrity.  Data is the foundation of life sciences companies.  It supports product development, FDA product approval, product release to market, and monitoring of product during manufacture.  That data must be reliable, or a company’s entire operation can be called into question.

 

Data integrity applies to all data generated by a company in support of cGMP, GLP, GCP, and other regulated activities.  Broadly speaking, such data must be complete, consistent, accurate, and remain that way throughout the data’s lifecycle.  Such a lifecycle starts with initial recording of data, continues through review, storage, and modification, and ends with archival or destruction after the retention period is completed.  To be fully compliant with regulations and to ensure data integrity, data must be recorded at the time it is observed, and once recorded, must be properly retained.  This includes not just the data itself, but metadata describing the context of the data including who recorded the data and when.  Any modifications made after the fact must be done in such a way that the original data is still available, that those making changes are identified, and that changes are justified.  When the quality unit makes product disposition decisions, all data generated in the manufacture and testing of that product must be made available for review.

 

The concept of data integrity applies to both paper based and electronic systems, though the implications for both are different.  Ensuring data integrity with paper-based systems requires robust procedures that ensure good documentation practices are followed, and staff appropriately trained on such procedures.  Additionally, such paper records have to be controlled, from initial issuance, through filing, and must be stored in such a way to ensure records are not lost or accidently destroyed.  Electronic systems must be designed in such as way that they are compliant with 21 CFR Part 11, and that staff are properly trained on use of such systems, with robust procedures.  This includes controlling user access and ensuring audit trails function properly to capture changes made to the system and identify who made those changes.  Lastly, electronic data must be properly backed up to prevent loss.

 

Data integrity is a broad topic that affects all parts of life sciences companies.  Ensuring data integrity requires a wide array of infrastructure including procedures, training, proper configuration and testing of electronic systems, and auditing to ensure procedures are followed.  Globiox offers all of these services and can help ensure the integrity of data at companies both large and small.  Whether you are a startup looking to establish programs to ensure data integrity, an established company looking to improve your processes, or if you have received 483 observations or warning letters related to data integrity, Globiox can provide consultants well versed in the solutions required to ensure data integrity.