Microsoft Azure GXP Guideline now published – reviewed by CCS

The goal of this GXP guidelines document is to provide life sciences organizations with a comprehensive toolset for using Microsoft Azure while adhering to industry best practices and applicable regulations. It identifies the shared responsibilities between Microsoft and its life sciences customers for meeting regulatory requirements, such as US-FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11), and EudraLex Volume 4 – Annex 11 Computerised Systems (EMA Annex 11).

Microsoft Azure GxP Guidelines – 06.12.2017 – Download

Events 2018: How to validate Software Development tools used for GXP and MedDev?

8 February 2018, Stuttgart, Germany (9 am to 5 pm)

Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany

The programme will focus on regulated companies that are in the process of the implementation and validation of software development tools like JIRA, BitBucket and Confluence (Atlassian). If such tools are used for GXP activities (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) these must comply with regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11.

Several standards and guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like ISPE GAMP, ISO 12207, IEC 62304, CMMI and AAMI TIR45:2012.

This conference covers regulations, standards, examples and solutions!

The event can also be found on XING Event Plus – OPEN LINK.

Register online here.

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EU-US mutual recognition of inspections

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.

Read more:

  • EMA Press Release
  • Third QP conference: QP challenges in modern pharmaceutical trading; 29. / 30. September 2017, Belgrade

    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: http://www.pharmacy.bg.ac.rs/files/Doga%C4%91aji/2017/QP%20konferencija/flajer%20engleski%202017.pdf

    US-FDA: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11— Questions and Answers; Draft Guidance for Industry

    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 and electronic signatures under our regulations in clinical investigations of medical products.

    Download: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11— Questions and Answers; Draft Guidance for Industry

    Article: Data Integrity – FOLLOW THE DATA (@pharmind June 2017)

    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 compliant and proper data categorization, how to define different useful types of audit trails and how to define and understand the so called “Audit Trail Review” in order to gain knowledge about the product and process attributes according to ICH Q10 and Q11. (…)

    READ MORE – ONLINE LINK

    Aktuelle Buch Neuerscheinung: Papierbasierte und elektronische Dokumentation im Pharmaunternehmen

    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.

    Dieses Fachbuch hilft Ihnen Schritt für Schritt, den Überblick über die Datenflut zu behalten. Neben Erläuterungen zu aktuellen regulatorischen Anforderungen finden Sie hier auch das 1×1 der guten Dokumentationspraxis im täglichen Umgang mit Dokumenten. Das Buch liefert Ihnen Informationen zu unterschiedlichen Systemtypen, GMP-relevanten Funktionen und Einsatzmöglichkeiten elektronischer Systeme. Mit diesem Wissen sind Sie gut vorbereitet für die nächste Datenflut!

    Aus dem Inhalt:
    • Erstellung, Lenkung und Kontrolle von Dokumenten
    • Dokumentation im Labor
    • Anforderungen an die Datenintegrität
    • Validierung eines Dokumentenmanagementsystems
    • Umstellung auf elektronische Chargendokumentation

    Mehr Informationen zum Buch: externer LINK

    GXP compliant JIRA & Confluence

    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 organizations achieve more.

    Continue reading “GXP compliant JIRA & Confluence”