PDA Points To Consider: Fundamental Concepts in Data Integrity

References

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   EMA/INS/GCP/454280/2010: Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials European Medicines Agency GCP Inspectors Working Group, 09 June 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/08/WC500095754.pdf (accessed 28 June 2016).
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   Elements of a Code of Conduct for the Pharmaceutical Industry, Parenteral Drug Association. March 2016 www.pda.org/CodeofConduct (accessed 29 June 2016).
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   U.S. Code of Federal Regulations Title 21 Part 211.25 Current Good Manufacturing Practice for Finished Pharmaceuticals Personnel Qualifications. U.S. Food and Drug Administration http://www.ecfr.gov/ (accessed June 27, 2016).
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   U.S. Code of Federal Regulations Title 21 Part 211.68 Automatic, mechanical, and electronic equipment. U.S. Food and Drug Administration http://www.ecfr.gov/ (accessed June 27, 2016).
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   Quality Guideline Q10: Pharmaceutical Quality System International Conference on Harmonization. June 2008.
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   U.S. Code of Federal Regulations Title 21 Part CFR 211.192 Production Record Review. U.S. Food and Drug Administration http://www.ecfr.gov/ (accessed June 27, 2016).
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   U.S. Code of Federal Regulations Title 21 Part CFR 211.100 Current Good Manufacturing Practice for Finished Pharmaceuticals: Written Procedures; deviations. U.S. Food and Drug Administration http://www.ecfr.gov/ (accessed June 27, 2016).