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JUL-AUG 2017

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Questions to consider l At what point are pass/fail results known by an analyst? Can they stop the process before anything is recorded? l How is the data backed up and archived? Does it include all raw data or only a printout or PDF? l How is data reviewed (paper only or go to the instrument)? l Are there any system folders other than the one the instru- ment is routinely using? l Can data be erased from the system? Can data be renamed? Can times or dates on the computer be changed? l Look at configuration settings: Is overwriting allowed? l How is access to the system controlled? What are the access levels, and who has them? l How frequently do they review the access levels? Data mapping Data mapping is important for understanding the path in- formation takes with raw data existing in many formats. For example, the chromatograph on the right side of the drawing could be printed as a PDF and used within the master batch record and lab records. That printout is static and does not indicate the history or record of what occurred. That information needs to be electronically fed back to the laboratory information management (LIM) system and the chromatography system, and the sys - tem needs to demonstrate all the metadata exists that il- lustrates how that testing was performed from the start through the release. Paper documents can be scanned and stored electroni- 32 INTECH JULY/AUGUST 2017 WWW.ISA.ORG AUTOMATION IT Electronic record(s) Electronic record(s) Batch doc controlled forms Raw data and records can exist in many places throughout our control system architecture. Are the controls in place to preserve the relevant raw data? PDFs are static data! Simple/complex instruments Controllers/recorders Computers/servers Active directory Historians/MES, etc. Primary record Primary record Primary record Primary record Attributable Legible Contemporaneous Original Accurate Complete Consistent Enduring Available Data integrity attribute System review categories Access/ Audit trail Repeat Change PC clock/ Event/ Backups/ security review testing control time stamp alarm archival Electronic systems are designed to consistently perform processes. Data can be checked for accuracy and completeness at time of initial entry through retention period . Examples

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