Consulting Company for Risk-based Quality Management, Quality Assurance, GxP-Compliance 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.|
Project News: Development of a validation framework and validation of Open-Source EDC software for a European physicians’ association
[09 December 2016] A European contract research organization (CRO), associated with an association of European physicians, needed to validate its Open-Source data collection system (EDC) for conducting clinical trials. Q-FINITY trained the organization's employees in the basics concerning GxP, CSV and Part 11, and provided the necessary SOPs and templates for validation and operation, while supporting the ongoing validation of the EDC system (OpenClinica) by coaching.
Project News: GVP Audit of Processes and Computerized Systems at a Pharmaceutical Manufacturer
[10 November 2016] A pharmaceutical marketing authorization holder and manufacturer contracts Q-FINITY to perform a routine audit of the pharmacovigilance system as part of their audit program. This included a review of corrective actions from previous audits to confirm their completion.
Project News: Auditing the clinical data management process of a university institute, including checking the validation documents of an Open-Source EDC software
[07 November 2016] A university institute (CRO) wished to perform clinical trials with an Open-Source electronic data capture (EDC) system. Q-FINITY was commissioned by the QA department of the university to perform an audit concerning the compliance of the validation project and the validation documents for the EDC system, as well as other regulatory documents necessary for conducting clinical trials.
Project News: GCP Audit of Processes and Computerized Systems at an academic CRO
[3 November 2016] An academic CRO contracts Q-FINITY to audit its GCP processes for compliance with regulatory requirements. The audit also included the processes and validation status of computerized systems used for data management and statistical analyses.
Project News: GCP Audit of Processes and Computerized Systems at an academic CRO and its Partners
[13 October 2016] An academic CRO contracts Q-FINITY to audit its GCP processes for compliance with regulatory requirements. The audit also included the processes and validation status of computerized systems at the partner institutes within the university responsible for statistical analyses and data management.
Project News: Review of the effectiveness of a CSV approach using a questionnaire
[25 July 2016] Q-FINITY was commissioned by a global pharmaceutical manufacturer to challenge its CSV validation approach, which has been in place for several years, with regard to further simplifications, optimizations and improvements (framework with templates, application in projects, support of tools used). A comparison of the method with other companies was also to be carried out. For this purpose, Q-FINITY created a comprehensive questionnaire, which is used to conduct interviews at the international level with people from different divisions and roles (business departments, IT, QA, external consultants of the customer). On the basis of the prepared results, detailed recommendations on the individual topics are proposed.
Project News: GVP Audit of Processes and Computerized Systems at a pharmaceutical Manufacturer
[27 June 2016] A pharmaceutical marketing authorization holder and manufacturer contracts Q-FINITY to perform a routine audit of the pharmacovigilance system as part of their audit program. The audit also focused on computerized systems that impact pharmacovigilance processes and on the particular role of the German Pharmacovigilance Officer within the company.
Project News: Review and optimization approach to the 21 CFR Part 11 capability of a planned ERP system
[10 June 2016] A manufacturer of high-performance ceramics for dentists and dental technicians is planned to introduce a new ERP system. The 21 CFR Part 11 capability of the new system was to be considered. In addition to this, Q-FINITY provided a workshop for the elaboration and the recommendations that should be taken into account regarding Part 11 in the new system.
Project News: Data Management Audit of processes and computerized systems at an academic spinoff company
[3 May 2016] An academic spinoff company contracts Q-FINITY to audit its data management processes for compliance with regulatory requirements. The audit also included the processes and documentation concerning the underlying computerized systems, including their validation status.
Project News: Validation of a laboratory process in a contract research organization
[15 April 2016] A bioanalytical contract research organization wanted to validate its process for high-sensitivity large-molecule bioanalysis, which is supported by a laboratory system and a subsequent, self-developed analysis and evaluation software (based on Excel with VBA). Q-FINITY provided the necessary SOPs and templates and carried out the validation activities with the customer.
Project News: Audit of the Quality Management Processes of a small/midsize CRO
[7 March 2016] A small-to-midsize CRO contracts Q-FINITY to conduct an audit of the quality management system in order to identify opportunities for improvement. The audit comprised all the processes associated with the QM unit and its documentation.
Project News: Audit of the GCP Safety Processes and the underlying computerized systems of a small/midsize CRO
[23 February 2016] A small-to-midsize CRO contracts Q-FINITY to conduct an audit of the safety processes and the underlying computerized systems. The audit included an assessment of the validation status of the pharmacovigilance software in use at the CRO.
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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