Archiving of Paper and Electronic Data of great Concern for FDA and EU Authorities

Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful audit or inspection for any GMP regulated quality control laboratory.

US GMP regulations state that “Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: …..”. In the FDA Guide to the Inspection of QC Laboratories is the statement “We expect raw data to be maintained in bound books or sheets for which there is accountability”. A number of high profile cases over the past few years have shown that data integrity is not maintained and can be fraudulent. The Able Laboratories fraud case in 2005 was one such instance where the data were fraudulently generated destroying any trust in the data integrity of laboratory data and the calculated results. However this is neither an isolated case nor the only area for concern as recent FDA warning letters indicated covering the integrity and security of laboratory data include the following citations throughout the whole pharmaceutical supply chain:

Loss of Data
The gas chromatographic analysis performed and the data provided to the application sponsor is not traceable to raw data. The original chromatograms could not be located during the inspection. (FDA Warning Letter, September 2010)

Data Falsification (impacting the integrity of the whole laboratory)
An analyst substituted IR spectra from a passing batch: This practice is unacceptable and raises serious concerns regarding the integrity and reliability of the laboratory analyses conducted by your firm. (FDA Warning Letter, January 2010).

Missing Documented Traceability of Results
Note that the copies of analytical notebooks submitted in your response remain incomplete in that they lacked: laboratory equipment/instrument information; standards and reagents information; filter information; dates and signatures of the persons who performed each test and reviewed the data; reference to the test method, version number, and effective date; and statement of how the test results compare with acceptance criteria. (FDA Warning Letter, August 2009).

A training course on Raw Data, Results and Reportable Values on 21 - 22 May 2012 in Copenhagen will provide you with the tools and techniques to define “complete data” in the context of paper, hybrid and electronic records to ensure the integrity and security of laboratory records regardless of the mode of generation.