Data integrity in pharmaceutical and medical devices by Orlando Lopez

By Orlando Lopez

Data integrity is key in a pharmaceutical and scientific units caliber method. This e-book presents sensible details to let compliance with information integrity, whereas highlighting and successfully integrating world wide rules into the topic. the information offered during this e-book are according to a long time’ event in regulated industries in a number of desktops improvement, upkeep, and caliber capabilities. as well as case reports, a pragmatic method should be awarded to extend potency and to make sure that the layout and checking out of the information integrity controls are appropriately achieved.

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For example: a. During the inspection, the investigator found no procedures for manual integration or review of electronic and printed analytical data for (b)(4) stability samples. Electronic integration parameters were not saved or recorded manually. When the next samples were analyzed, the previous parameters were overwritten during the subsequent analyses. , Ltd Oct 2015 Statement of noncompliance with GMPs Article 47 of Directive 2001/83/EC (API) (Continued) Two of 10 major deficiencies were related to data integrity, computer system validation, and change control.

European Union’s GMP guideline 2003/94/EC (EU GMPs) Regulation Entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner. (Competent Authority of United Kingdom) The computer system being used for HPLC did not have adequate controls to prevent unrecorded changes to data. (MHRA) It was not possible to confirm the validity of stability testing data. Several falsified and inaccurate results had been reported in long-term stability and batch testing.

We acknowledge your commitment to take corrective actions and preventive actions to ensure that your laboratory instruments and systems are fully compliant by January 15, 2015. In response to this letter, provide a copy of your system qualification to demonstrate that your electronic data systems prevent deletion and alteration of electronic data. , installing better systems or software) if your qualification efforts determine that the current system infrastructure does not ensure adequate data integrity.

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