GCP: study integrity – trail integrity – data integrity

GCP: study integrity – trail integrity – data integrity

Data integrity requirements define the assurance that records are accurate, complete, intact and maintained. These requirements are basic GCP requirements as defined in ICH E6. CCS offers detailed GCP data integrity checks and assessments for the Study Design and Reporting,

The new MHRA Inspectorate blog

In June 2015 the MHRA has published their Inspectorate Blog. Read more at (external links): MHRA Blog Welcome Page  MHRA Guidelines MHRA Data Integrity Part 1 – first blog message   You can also request an automatic email: Request Contact us

PTS Training: GMP Datenintegrität und Rohdatenmanagement am 20.10.2015 in Darmstadt

PTS Training zum Thema Datenintegrität und Rohdaten-Management am 20.10.2015 in Darmstadt: Sie erfahren den Gesamtüberblick der Definitionen und Anforderungen an die Datenintegrität! Praxisumsetzung dieser Highlight: Datenmanagement, Datenspeicherung und Zugriff inklusive Benutzermanagement, elektronische Daten und Ausdrucke, Datenänderungen inklusive Audit Trail, Sicherung

50 Years of EU Pharmaceutical Legislation – EudraBook

2015 marks the 50th anniversary of the adoption of the first law on the authorisation of pharmaceuticals at EU level, which set the basis for some of the key principles that are still valid today. Read more: http://ec.europa.eu/health/human-use/50years/ Download (free):

GMP Datenintegrität – Schulung in der Schweiz – Mai 2015

Speziell zum Thema Datenintegrität & Rohdatenmanagement wird am 12.05.2015 in Olten – CH eine 1-Tages Schulung stattfinden. Obwohl viele Systeme im Labor als validiert gelten, sind diese heutig im Inspektionsfokus nicht mehr als valide zu verteidigen. Exemplarisch soll Bezug genommen werden auf

Audit Service Center: Shared Third Party Audits by CCS

The Audit Service Center (ASC) is an independent provider of value-added regulatory quality and audit management services. Starting with the existing compliance programs of our clients we optimize such programs and manage quality audits of manufacturers of materials, products, components, and

Validation Templates

CCS provides ready-to-use Validation Procedures, Templates and Forms. Each package includes additional integration and support services. Templates, forms and documents will be provided in MS Word / MS Excel format, as download versions or during integration workshops on site. You

Annex 15: Qualification and Validation – Revision 2015

The new EudraLex  Annex 15 describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. Deadline for coming into operation: 1 October 2015 Download Annex 15 Now