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™ 10 Enhanced Security (ES) software platform for infrared spectroscopy provides structural requirements and features to assist with the needs for ensuring data integrity and compliance. 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 10 ES meets the technical requirements for 21 CFR Part 11.