Change to S4 / HANA for a globally established SAP R/3 system of a pharmaceutical company

S4/HANA is the new version of SAP that brings fundamental changes in data management and requires extensive technical customization and testing as part of a technical update. QFINITY ensures the quality of the upgrade in the role of Validation Manager, which also includes the development of a plan for running parallel versions and, in particular, for updating the validation documents. The SAP smartShift Tool is used, which allows a semi-automatic modification of the source code and whose qualification is part of the project.

Roll-out SAP and EWM (Extended Warehouse Management) worldwide

The SAP and EWM systems constituting the core company systems for the financial and especially the logistical processes are to be consolidated at a global pharmaceutical company.  Existing legacy systems are to be replaced and their data migrated. QFINITY provides the project quality assurance for change management, document life cycle, testing and data migration.

Workshop to analyze the data integrity of a HPLC software

To define requirements for the software provider and internal processes for the implementation of a new HPLC software, QFINITY leads a workshop to analyze the data, processes and planned infrastructure.

Regulatory Compliance Check at a Contract Research Organization (CRO)

CRO contracts QFINITY to plan and conduct regulatory compliance checks.

Training und Workshop at a Contract Research Organization (CRO)

CRO contracts QFINITY to plan and conduct basic training in validation of computerized GCP systems. In a supplementary Workshop, the established QM system was analyzed to identify significant weaknesses.

QFINITY consults about the 21 CFR Part 11 in the U.S.

A major U.S. Pharma company commissioned QFINITY for the production of an expert opinion regarding the implementation of FDA 21 CFR Part 11 / EU GMP Annex 11 for the introduction of an Electronic Clinical Supply Management system, including Interactive Voice & Web Response Services (IVRS / IWRS ).

IT-Compliance at a Pharmaceutical Manufacturer

A mid-size manufacturer of pharmaceuticals contracts QFINITY to plan and execute a global validation strategy for all computerized systems.

SAP R/3 Validation at a Medical Technology Company

A reputable manufacturer of medical technology contracts QFINITY to plan and support SAP R/3 validation activities.

Clinical studies in medical technology

QFINITY supports major manufacturers of medical technology in the validation of a clinical trial management system (CTMS) including the connection to a statistical software.

Introduction of a DMS with a medical manufacturer

QFINITY supports a medium-sized enterprise with the requirements analysis, supplier selection, implementation (including prospective validation) of a document management system (DMS) in accordance with the requirements of 21 CFR Part 820, ISO 13485 and 21 CFR Part 11.

Validation approach for statistical software

QFINITY developed a strategy for achieving the compliance of SAS installations including a generic approach for the validation of study-specific and cross-study programs for a customer.

Review and streamlining of IT SOPs at a pharma company

Pharmaunternehmen beauftragt QFINITY damit, die IT-SOP Landschaft erheblich zu “verschlanken”. D.h. Dokumente sind sowohl in ihrer Anzahl als auch in ihrem Umfang zu reduzieren, ohne dadurch die regulatorische Belastbarkeit zu gefährden.

Online Training Asia/Pacific

Medical technology company contracts QFINITY to plan and conduct online training sessions for employees of its IT departments, including modification of the existing training materials for online training.

Implementation and Validation of an UDI-Lösung

Strategic and operative support for a project to impelement a system landscape for automated transfer of product information to the FDA. The project was intended to create a technological foundation for facilitating the automated transfer of product data from an SAP system tot he GUDID of the FDA via an external gateway.

Audit of an electronic batch record (EBR)

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.

SAP Release Change at a pharmaceutical manufacturer

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. QFINITY will provide strategic and conceptual support for this project.

Implementation of a Field Service Management Solution based on Salesforce

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, QFINITY 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).

Data Integrity – Workshop and Gap Analysis

An API manufacturer wishes to conduct a data integrity analysis in preparation for an FDA audit planned for the mid-term. QFINITY 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.

Approach to the Qualification of IT infrastructure

In the context of centralizing its IT services, a pharmaceutical manufacturer has contracted Q-FINITY to support the implementation of an approach for qualifying the IT infrastructure. QFINITY provides coaching through client workshops in order to provide basic knowledge as a foundation for QFINITY‘s ongoing support.

Audit of the GCP Safety Processes and the underlying computerized systems of a small/midsize CRO

A small-to-midsize CRO contracts QFINITY 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.

Audit of the Quality Management Processes of a small/midsize CRO

A small-to-midsize CRO contracts QFINITY 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.

Validation of a laboratory process in a contract research organization

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, QFINITY provided a workshop for the elaboration and the recommendations that should be taken into account regarding Part 11 in the new system.

Data Management Audit of processes and computerized systems at an academic spinoff company

An academic spinoff company contracts QFINITY 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.

Review and optimization approach to the 21 CFR Part 11 capability of a planned ERP system

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, QFINITY provided a workshop for the elaboration and the recommendations that should be taken into account regarding Part 11 in the new system.

Review of the effectiveness of a CSV approach using a questionnaire

QFINITY 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, QFINITY 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.

Auditing of the GVP processes and the underlying computer-aided systems at a pharmaceutical manufacturer

A pharmaceutical manufacturer hires QFINITY to conduct a routine audit of the pharmacovigilance system to verify compliance with regulatory requirements. The audit also includes the relevant computer-aided systems that influence processes in the pharmacovigilance area, as well as the special role of a qualified person in the company.

Auditing of the GCP processes and the underlying computer-aided systems at a university KKS and its university partner organisations

A coordination centre for clinical studies in the university sector commissions QFINITY with the auditing of its GCP processes. The audit also includes two partner institutes of the university who are responsible for statistics and data management and also examines the computerized systems used and their validation.

GCP Audit of Processes and Computerized Systems at an academic CRO

An academic CRO contracts QFINITY 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.

Auditing the clinical data management process of a university institute, including checking the validation documents of an Open-Source EDC software

A university institute (CRO) wished to perform clinical trials with an Open-Source electronic data capture (EDC) system. QFINITY 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.

Development of a validation framework and validation of Open-Source EDC software for a European physicians’ association

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. QFINITY 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.

Track & Trace for a phytopharmaceutical manufacturer

QFINITY supports the introduction and implementation of a concept for the regulation-compliant introduction of “track and trace”. Based on the legal requirements, a concept was developed in close cooperation with the client, which would also allow smaller manufacturers an economical way to meet legal requirements.

Data Governance and Data Integrity at a large pharmaceutical company

QFINITY creates the basis for the establishment and implementation of a comprehensive set of guidelines for the company-specific and effective fulfillment of data governance and data integrity requirements in a large, corporate-affiliated pharmaceutical company.

Workshop Audit Trail Review

Due to the requirements of Annex 11 regarding audit trail review, companies are increasingly trying to standardize their procedures. Especially with complex systems like ERP (Enterprise Resource Planning), different aspects of the system have to be considered. As part of the launch of a new ERP system, QFINITY collaborates with a pharmaceutical company to define a process for this activity.

Production optimization at a North German manufacturer of phytopharmaceuticals

QFINITY accompanied the optimisation and rationalisation of the bottling and packaging line throughout the entire project phase, from the preparation of the specifications and system selection to the completion of the validation activities.

Preparation of a Service Level Agreement (SLA)

With the requirements of Annex 11, the implementation of a Service Level Agreement (SLA) between the business department and the IT department is essential. QFINITY supports a pharmaceutical manufacturer in the preparation and coordination of the contents of the SLA.

Introduction of SAP Governance, Risk & Compliance (GRC)

Authorization management, especially critical access and segregation of duties (SoD), are central topics of audits. Therefore, many companies introduce central solutions to technically support or control these issues. The global ERP system is particularly important here. The introduction of SAP Governance, Risk & Compliance (GRC) has become an elementary component of the SAP lifecycle, as processes such as change management can be supported centrally and system-oriented. QFINITY introduces SAP CHaRM (Change Request Management) for various SAP systems around the world at one of the leading pharmaceutical manufacturers as a technical expert and project manager.

Definition of the general procedure for the operation and the qualification of an IT infrastructure

Many companies have individual procedures for the operation and qualification of infrastructure components, but they often do not have a centralized, unified approach. QFINITY conducts training on infrastructure control requirements at a pharmaceutical company and uses it to create comprehensive SOPs and templates.