By Orlando Lopez

Data integrity is prime in a pharmaceutical and scientific units caliber method. This publication offers functional info to allow compliance with facts integrity, whereas highlighting and successfully integrating world wide law into the topic. the information offered during this publication are in accordance with decades’ event in regulated industries in a variety of desktops improvement, upkeep, and caliber services. as well as case stories, a realistic method should be awarded to extend potency and to make sure that the layout and checking out of the information integrity controls are thoroughly achieved.

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Extra resources for Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance

Example text

This practice is repeated until passing and/or desirable results are achieved. 2. Established laboratory control mechanisms are not followed. Electronic records are used, but they do not meet systems validation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. (Italian Medicines Agency) Failure to manage laboratory systems with sufficient controls to ensure conformance to established specifications and prevent omission of data. Other significant deficiencies noted in your laboratory system include failure to use separate passwords for each analyst’s access to the laboratory systems.

Data integrity. (Source: Health Canada) Regulatory partner. Data integrity. (Source: Health Canada) Regulatory partner. (Continued) Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. a. The inspection found that the audit trail feature for your GC instruments was not used until October 2013, even though your 2009 GC software validation included a satisfactory evaluation of the audit trail capability. b. There is no assurance that you maintain complete electronic raw data for the (b)(4) GC instruments, the Malvern particle size analyzer, and the ultraviolet (UV) spectrophotometer.

Some instruments had date and time functions unlocked and were not linked to a server, so time stamps could be manipulated. One HPLC had a shared password so actions were not attributable to a particular individual. In some cases, trial injections were carried out but were not included as part of the test record. A general login on one computer allows data stored on the hard drives of these instruments to be changed or deleted by any user. 1 (Continued) 2013–2016 Cases Relating to E-Records Integrity 14 ◾ Data Integrity in Pharmaceutical and Medical Devices (Continued) b.

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