Consulting Company for GxP-Compliance, Quality Assurance and Continuous Improvement of Processes, Data and Computerized Systems
|We provide professional compliance services for pharmaceutical and medical device companies. We support start-up companies as well as SMEs and global corporations throughout the entire product lifecycle.|
Events: German-language Seminar "The EU Clinical Trials Regulation and ist impact", 21 October 2015 in Frankfurt a.M.
[14 September 2015] This seminar is hosted by Colloquium Pharmaceuticum and will give participants an overview of the most important content of the new EU Regulation 536/2014 on clinical trials, including the new submission and approval procedures, reporting requirements and the EU portal / EU database. Dr. Jenny Gebhardt, Medical Director at Q-FINITY, will present information on what pitfalls for auditing the new Regulation may present, as well as how the Regulation impacts safety processes.
Events: Meet Q-FINITY at the 8th GAMP 5 Conference in Mannheim
[06. August 2015] Are you new to the topic of „Validation with GAMP 5“ or do you want to know more about Industry 4.0?
The visit us at the der GAMP 5 Conference in December in Mannheim. Mr. Herrmann (Q-FINITY) and Dr. Spingat (Bayer Pharma AG) will introduce participants to key content such as specifications, risk management and their respective purpose in the context of verification/ validation. Mr. Mierau (Q-FINITY) and Dr. Terhechte will then give a presentation on Industry 4.0 and present ideas on Qualification and Validation as well as Data Integrity and Security.
Events: 2nd GAMP GCP Conference in Mannheim
[04. August 2015] The 2nd GAMP GCP Conference’s motto this year is "(e)Clinical Trials - Clinical Research for the 21st Century" and will again address the topic of validation of computerized GCP-systems. Experts from industry, regualtors and service providers will present current case studies, trends and developments. Q-FINITY will be represented by Oliver Herrmann, who will chair the conference and give a presentation ("Risk-based Auditing of computerized GCP systems“), as well as Dr. Jenny Gebhardt, who will present a case study on the topic of GCLP compliance ("Processes in clinical laboratories and compliance of their systems – GCLP“).
Focus: Risk-based Quality Management / Risk-based Monitoring, Moving from paper to electronic solutions, Auditing of computerized GCP-Systems, electronic source data (eSource), electronic signatures in clinical trials, archiving of clinical data, contemporaneous copy of CRF data, digitalization of patient files, GCLP (Good Clinical Laboratory Practice)
Publication: Pharma Technologie Journal - IT-Trends im GxP-Umfeld [IT trends in the GxP fields]
[1 August 2015] In this German-language publication, established experts from industry, consulting and suppliers provide insights into current trends and their practical implications in the GxP fields. Among the authors, Q-FINITY is represented by Oliver Herrmann and Dr. Jenny Gebhardt ("Validierung von computergestützten GCP Systemen: Grundlagen, Ansätze, Herausforderungen und Trends" [Validation of computerized Systems: Basics, Approaches, Challenges and Trends]) and Dr. Stefan Schaaf ("Enterprise-Managementsysteme als Basis für GxP-Compliance in der Life-Science-Industrie" [Enterprise Management System as the Foundation for GxP compliance in the Life Sciences Industry]).
More information: Order this publication here ! - ISBN: 978-3-87193-302-8
Project News: Approach to the Qualification of IT infrastructure
[23 June 2015] In the context of centralizing its IT services, a pharmaceutical manufacturer has contract Q-FINITY to support the implementation of an approach for qualifying the IT infrastructure. Q-FINITY provides coaching through client workshops in order to provide basic knowledge as a foundation for Q-FINITY’s ongoing support.
Project News: Data Integrity- Workshop and Gap Analysis
[5 May 2015] An API manufacturer wishes to conduct a data integrity analysis in preparation for an FDA audit planned for the mid-term. Q-FINITY is training the client in the basics concerning GxP, CSV and data integrity and is analyzing the systems (automation, laboratory and IT) in order derive an action plan to ensure conformity with requirements.
Project News: Implementation of a Field Service Management Solution based on Salesforce
[27 April 2015] To support its Field Service Management a medical device manufacturer planst o implement a software solution based on Salesforce basierenden Software-Lösung. The goal is primarily to collect information on key indicators. In the context of this project, Q-FINITY has a supporting role, for example in analyzing the requirements, in performing risk analyses and in ensuring GxP-compliant implementation of the system (Audit Trail, handwritten signatures on electronic devices). A GxP-compliant template is being created for worldwide rollout (multi-site approach).
Project News: SAP Release Change at a pharmaceutical manufacturer
[30 April 2015] The client plans to upgrade his SAP system landscape (using SAP HANA in-memory database technology) and wants use this opportunity to improve the company’s approach to implementation, validation and operation of these systems. Q-FINITY will provide strategic and conceptual support for this project.
Project News: Audit of an electronic batch record (EBR)
[11 April 2015] Our medical technology client wants to establish the electronic batch record as the central tool for production documentation (including archiving). The contracted audit is intended to verify the regulatory compliance (USA / EU) of the implementation project, the computerized processes for producing an electronic batch record and the implementation of the process in an electronic tool (SAP), while also checking for weaknesses in the logistical sequence.
Q-Services for ERP-Systems and Medical Technology
[17 March 2015] Q-FINITY expands its services for validating processes, data and systems in the area of ERP Systems (SAP, Infor, Microsoft etc. ) and medical technology.
ISPE GAMP D-A-CH News
[15 March 2015] Oliver Herrmann, CEO of Q-FINITY, will be replacing Dr. Heinrich Hambloch as Deputy Chair of the GAMP D-A-CH group and was introduced in his new role at the last GAMP D-A-CH meeting in Berlin.
Webinar, 16. November 2015, Risk-Based Monitoring in Clinical Trialss (in german language)
[14 January 2015] This webinar presents the concepts behind risk-based monitoring in clinical trials with two initiatives as examples, namely ADAMON and Transcelerate. Participants will be able to more clearly understand the idea of risk-based monitoring and will receive insights into two (freely accessible) methologies with different tools for supporting implementation of their techniques.
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