New PDF release: Data integrity in pharmaceutical and medical devices

By Orlando Lopez

ISBN-10: 1498773249

ISBN-13: 9781498773249

Data integrity is key in a pharmaceutical and scientific units caliber approach. This booklet offers sensible details to permit compliance with facts integrity, whereas highlighting and successfully integrating all over the world legislation into the topic. the information offered during this publication are in line with a long time’ event in regulated industries in a number of desktops improvement, upkeep, and caliber capabilities. as well as case experiences, a pragmatic process could be awarded to extend potency and to make sure that the layout and trying out of the information integrity controls are accurately achieved.

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Additional info for Data integrity in pharmaceutical and medical devices regulation operations: best practices ... guide to electronic records compliance

Example text

You do not have a record of the acquisition of all data, nor do you have records of changes to or modifications of such data. L Rusa Pharma LTD Cadila Healthcare Limited A Letter of Concern (WHO) GMP Statement of NonCompliance to GMPs Statement of NonCompliance to GMPs Art. 111(7) of Directive 2001/83/EC as amended Art. 80(7) of Directive 2001/82/EC as amended Art. 15 of Directive 2001/20/EC Art. 111(7) of Directive 2001/83/EC as amended Art. 80(7) of Directive 2001/82/EC as amended Art. 15 of Directive 2001/20/EC ◾ (Continued) Inaccuracies on environmental monitoring area.

The raw data generated from the semiautomated thickness tester used to measure the thickness of perimeter seals on bags used as container closure systems for injectable drugs can be overwritten with new data without explanation and the original data is erased from the computer’s memory when overwritten. 194(a) 2003/94/EC (EU GMPs) (Continued) The agency observed manipulation and falsification of documents and data in different departments. There was no raw data available in the QC laboratory for the verification of compendial analytical methods.

Inspection Trends ◾ 31 Nov 2015 Nov 2015 Dr. 68(b) API Regulation Observation 6. “Your firm failed to establish appropriate controls over computers and related systems to ensure that changes in master production and control records or other records are instituted only by authorized personnel (21 CFR Part 211. 68(b)). , HPLC systems are configured so that no passwords are required to log in and no access controls to prevent alteration or deletion of data. Provide specific details of the steps you have taken to prevent unauthorized access to your electronic data systems and to ensure that data systems retain complete, accurate, reliable, and traceable results of analyses performed.

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Data integrity in pharmaceutical and medical devices regulation operations: best practices ... guide to electronic records compliance by Orlando Lopez


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