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:
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 calculated that a chromatography method cost about $5 per run, including reagents, labor, electricity, and average instrument maintenance cost. Reducing the overall run time was not as important as reducing the number of runs each day. One justification for their LIMS was reducing the number of retests and repeats.
Another client took a different approach and calculated that reagents, labor, electricity, and average instrument maintenance costs came to about $100/hour for each of five reactors. This lab could not reduce the number of reactor loads, but reducing reactor run time was one justification for a LIMS purchase.
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.