The FDA defines data integrity as “completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)”. ALCOA itself has evolved to ALCOA Plus, which incorporates two of the fundamental definition terms as stated by the FDA; complete, consistent, enduring and available. Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell products into the United States, and also applies to other related industries.
PerkinElmer’s Spectrum™ FL Enhanced Security (ES) software platform for fluorescence spectroscopy provides structural requirements and features to match the specific needs for ensuring data integrity. It affords the system owner the ability to comply with regulations and incorporate features into the validation plan to exhibit compliance. The purpose of this document is to demonstrate how Spectrum FL ES meets the technical requirements for 21 CFR Part 11.