Event: “EU-MDR: Perspektiven und Potenziale”
Datum: 07. Februar 2019
Veranstaltungsort: Aesculap Academy
Besuchen Sie uns bei der Veranstaltung “EU-MDR: Perspektiven und Potenziale”.
Wir wollen Ihnen zusammen mit unseren Partnern die Möglichkeit bieten, sich mit Experten aus der Medizintechnikbranche, die Einblicke und Meinungen zu aktuellen regulatorischen Fragen in der Branche haben, auszutauschen. Die Veranstaltung umfasst interaktive Workshops sowie direkten Meinungsaustausch.
Mehr zum Event, Programm und zur Anmeldung….
On 30 November 2018 PIC/S revised the current revision of PI 041-1 – DRAFT 3.
Here is the announcement from the PIC/S website (source)
Focused stakeholders consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Geneva, 30 November 2018: a revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)) has been prepared by the PIC/S Working Group on Data Integrity, co-led by Australia / TGA and UK / MHRA.
The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonised approach to the inspection, including reporting in regards to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.
The document (PI 041-1 (Draft 3)) is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period.
The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.
To submit feedback, please provide feedback exclusively on the dedicated template available on the websites of the below associations and submit by e-mail with subject line “PIC/S Focused Public Consultation – Data Management and Integrity” to one of the following associations which will collect and compile responses. Stakeholders should only reply once.
To download the consultation document (PI 041-1 (Draft 3)) please consult the page “Publications” or click on the link below:
PIC/S requests a Focused Public Consultation on Data Management and Integrity until 28. February 2019, which is highly appreciated. Please feel free to comment on the Guidance – it will be your benefit to do so.
CCS is preparing a detailed review in January 2019 in order to provide substantive comments on the current DRAFT 3 version.
Read more – Download Center
After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions was published in March 2018.
Looking into the history of the document and content the major changes have been to replace and extend from “GMP” to GXP (covering GCP, GDP, GLP, GMP and GPvP). All this GXP areas had already requirements for data integrity or study integrity or similar for many years and are covered by European EMA regulations, directives and the EMA EudraLex Volumes or other regulations (e.g. chemical for GLP). The second change was the title “Guidance for Industry” to a “Guide“. Maybe the document type “Guidance for Industry” would remind you to US regulations and you are right. But in the EU such a document type in a regulatory structure and understanding is also not known. Maybe the roots of the first versions were coming from US or consultants or authors from this region. In general an own opinion might be better as to listen to any opinion-makers with commercial interests. Continue reading “MHRA’s GXP data integrity guide published – March 2018”
Read our new article on LinkedIn: Software Development
Validation of SDLC tools like Confluence, JIRA according ISPE GAMP 5.
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
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 organizations achieve more.
Continue reading “GXP compliant JIRA & Confluence”
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 by a system?
And who will analyze in detail and finally judge the results of the Audit Trail Review?
Continue reading “Who will review the Audit Trail Review?”
In 2016 a lot of questions were asked about the good old Audit Trail and about the new topic of the so called “Audit Trail Review”. CCS has published a concept paper for an Audit Trail Specification and some considerations for the Audit Trail Review approach.
- What is an Audit Trail – in the GMP context of the PQS?
- What is the difference of a log and a GMP Data Audit Trail?
- What is an Audit Trail Review good for? How often? Why?
- What should be reviewed – function or data? What are the results – knowledge management?
- Detection of data manipulation? Data Audit Trail or Activity Trail required?
- Which data should be audit trailed and which one should be reviewed?
- What are CPPs, CQAs, system parameters and/or master data / meta data?
- How should a specification look like for a real GMP Data Audit Trail?
- Why is the reason for change so important for a real GMP Data Audit Trail?
- User roles and concept: Different types for the role Administrator?
- GMP documentation with instructions and records vs. electronic data?
- What is GMP critical data and knowledge management – on product and process level?
- Which roles should be audit trailed and when and if so, how?
- Is the Audit Trail Review executed manually or automatically?
You may find some answers or at least ideas for that in the free download provided by CCS below:
Download (revision 1): CCS_ Audit Trail Specification and Review_ 2017_rev1
Find more free Downloads at our: Download Page
Link – New Article: Who will review the Audit Trail Review?
Contact us for more information: mailto:email@example.com
comes compliance services (CCS), a leading GXP consulting service provider, for Pharmaceutical Quality Systems, Data Governance and Integrity, Computer System Validation and Inspection Readiness Programs, today announced that it has acquired more than 100 business customers since the launch of its services in 2009. Pharmaceutical and Medical Device customers rely on the compliance and consultancy services since many years provided by CCS. About 80 % of CCS projects are repeat-business and sales continue to ramp steadily. Continue reading “CCS – 100 – business customers reached in 2016”