It affords the system owner the ability to comply with regulations and incorporate features into the validation plan to exhibit compliance. PerkinElmer s UV WinLab Enhanced Security (ES) software platform for UV/Visible spectroscopy provides structural requirements and features to assist with the needs for ensuring data integrity and compliance. 2 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. 1 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. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). 1 WHITE PAPER Data Integrity UV WinLab Enhanced Security (ES) Software for UV/Visible Spectroscopy Introduction The FDA defines data integrity as "completeness, consistency, and accuracy of data.
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