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CCS News Ticker:

  • Read our new article on LinkedIn: Software Development Validation of SDLC tools like Confluence, JIRA according ISPE GAMP 5.
  • The Conference is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons. 29. and 30. September 2017 Venue Best Western Hotel M 56a Bulevar Oslobođenja Street, Belgrade Read more: …
  • The US FDA Agency  was announcing the availability of a draft guidance for industry entitled ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records …
  • Data integrity has become a major challenge but also a chance for modernization and optimization. To comply with expectations and regulations, companies need to analyze their overall GMP data management, system landscape and related GMP data flows. The following article outlines a basic data-flow oriented approach for such data assessments, as well as considerations for …
  • Auszug aus dem GMP-BERATER Dokumentation ist ein wesentlicher Bestandteil des pharmazeutischen Qualitätssystems. Sie spielt in jeder Phase des Lebenszyklus eines Arzneimittels eine wichtige Rolle, denn die Qualität eines pharmazeutischen Produktes muss zweifelsfrei nachweisbar sein! Deshalb ist es kaum verwunderlich, dass viele Verantwortliche aus dem Pharmabereich mit einer wahren Flut an Daten und Dokumenten kämpfen müssen. …
  • Please find below the German translation of PIC/S PI 041-1: GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS Deutsche Übersetzung (freie Übersetzung) des PIC/S PI 041-1: Link: Übersetzung PI_041_1_Draft_2_Guidance_on_Data_Integrity Find more information and download for free at: DOWNLOADS
  • Partnership Announcement Radbee and CCS CCS is delighted to announce a strategic partnership with Radbee Ltd. London, UK. RadBee Ltd. offers software solutions for quality assurance in the medtech, biotech and pharmaceutical industries. By tailoring JIRA and Confluence software to meet their clients’ specific needs, RadBee Ltd. creates quality management systems that make compliance easy and help …
  • You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome. Get practical knowledge of: What inspectors are looking for Successful preparation and management of Inspections Typical compliance issues and proactive compliance …
  • Die Datenintegrität der GMP-Daten ist ein zentrales Inspektionsthema. In diversen US FDA Warning Lettern als auch EMA GMP Reports werden bereits entsprechende Mängel dargestellt. Im Seminar lernen Sie die Anforderungen an die Datenintegrität kennen und Sie erfahren die aktuellen Richtlinien und Inspektionsergebnisse. PTS Schulung am 13.-14.06.2017 in Baden-Baden: Link für mehr Infos und zur Anmeldung… …
  • Seriously, who will review the Audit Trail Review? First who will execute the Audit Trail Review? An internal Quality role – in the course of the batch by batch execution and review of records, during internal inspections or during an regulatory inspection preparation? Or weekly, bi-monthly or every third batch – or simply just all audit trails created …