Data Integrity
Data integrity is more complex than just knowing where your data is stored and who has access. The FDA’s 2018 guidance “Data Integrity and Compliance with CGMP Guidance for Industry” clarifies the role of data integrity in the regulated space. The FDA expects all data, whether electronic or on paper, to be attributable, legible, contemporaneous, original and accurate (ALCOA). The guidance recommends implementing meaningful and effective strategies to manage data integrity risks based upon process understanding, management of technologies, and business models.
But what does this guidance mean for your business and your lab? CSols tailors our data integrity engagements to meet the needs of individual clients. (watch data integrity video)
True data integrity means being able to answer:
- Where is my data?
- How does my data move through my local systems?
- How does my data move through my enterprise systems?
- Who has access to my data?
- Does my data adhere to ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate)?
- Is my data protected?
- Is all my data readily retrievable?
If you can’t answer all of these questions with confidence, CSols can help you bring your data under control. We have the experience and expertise to help you evaluate systems and processes to ensure your data is exactly where, and what you think it is.
One client realized they had limited ability to search for data and could not confirm if the paper they found with data was the current version or had been reintegrated. They could not ensure if the paper printout represented the reported data. Moving to an entirely validated electronic LIMS gave them peace of mind that the data reported was accurate and could be readily searchable, saving at least one man day for each search of data.
Our process begins with an in-depth data integrity assessment for your laboratory data. We focus on the completeness, consistency, and accuracy of regulated data collected, maintained, analyzed, and/or reported by your computer systems.
Our Consultants work with your staff to help you identify data integrity risks and gaps and recommend corrective actions and remediation activities.
CSols can help support your data integrity program.