This magic phrase, Data Integrity

Very many people, if not everyone, are now hearing the charming phrase “Data Integrity”. This intuitively recognized concept has quickly burst into pharmaceutical use as a fairly large number of manuals devoted to this issue have been published in recent years: WHO TRS 996, Annex 5, Guidance on good data and record management practices Data … читать далее →

In tune with the times! Hotel based courses in EU by Compliance and Validation Ltd.

In November 2018 LabPromEngineering’s head of validation department Oleksandr Belinskyi was attended the hotel based courses, organized by Compliance and Validation Ltd. (UK). From 6 to 8 of November in Copenhagen there were HVAC systems in focus, from 20 to 22 of November in Amsterdam there was the pharmaceutical sterilization under discussion. The attendees were … читать далее →

LabPromEngineering takes part in review of ISPE guidances

ISPE Baseline Commissioning and Qualification 2nd edition. The purpose of this Guide is to provide a detailed description of a science and risk-based approach for the Commissioning and Qualification of Facilities and Equipment, providing an update to the Baseline® Guide on C&Q that is adequate to allow the development and implementation of an efficient effective … читать далее →