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CCS News Ticker:

  • 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 …
  • 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? … ...
  • 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...
  • This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work. Special Work Shop on Data Integrity: Why it is so important for QPs? How can the QP be sure about the integrity of data: what … ...
  • Come and visit us the ILMAC Messe Basel to the Data Integrity session on 20. September 2016, 09:30 – 12:40. Read more: External Reference
  • 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 …
  • Europe EMA (Q&A GMP) – see below full text PIC/S: PI_041_1_Draft_2_Guidance_on_Data_Integrity_2 WHO – Technical Report 996 – WHO_TRS_996_annex05 British MHRA (before “Brexit”): July 2016 Draft US-FDA: Guidance for Industry: US-FDA Data Integrity EMA Q&A: Data integrity (NEW August 2016) Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities. It is a fundamental …