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Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11— Questions and Answers; Draft Guidance for Industry

The US FDA Agency  was announcing the availability of a draft guidance for industry entitled ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties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Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11— Questions and Answers; Draft Guidance for Industry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”

Who will review the Audit Trail Review?

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?”

Audit Trail Specification & 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:talk@comes-services.com

CCS – 100 – business customers reached in 2016

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”