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”

ECA Training: Inspection Management – How to Pass EU and FDA Inspections

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
  • Performing a MOCK Inspection
  • The psychology of inspections

Download the PDF program…

ECA Training: Hamburg, Germany

Read more or register….

PTS Schulung: GMP Datenintegrität am 13.-14.06.2017 in Baden-Baden

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…

Teilnehmerfeedback aus dem letzten Kurs:

Inhalte sehr detailliert und praxisnah; gute Darbietung; lebhafte Diskussion Gute Atmosphäre; aktive Mitarbeit; Zahlreiche Workshops und praktische Beispiele waren super!

Link zum ausführlichen Feedback-Bericht

Kontakt: talk@comes-services.com

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

PTS Seminar: GMP Datenmanagement – Behörde und Industrie im Dialog

Seminar, 30.03.2017 in Unna bei Dortmund

Bedeutung des Data Governance Systems für die Pharmawelt:

  • Von messbaren Datenparametern: Sicherstellung von Datenintegrität, Vertraulichkeit, Verfügbarkeit, Authentizität, Verbindlichkeit
  • Von der Datenerhebung und Datenerfassung, über Datendokumentation, Datenverwendung / Prozessieren, Datenablage zur Datenarchivierung
  • Von Entwicklungsdaten, zu Prozessdaten, zu qualitätsrelevanten Freigabedaten, Qualitätskennzahlen zum digitalen Information Management über den gesamten Life-Cycle
  • Hin zur Frage: Was sind Faktoren der digitale Wertschöpfungskette in der Pharmaindustrie?

Lesen Sie mehr zu diesem PTS Training…

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”