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LabWare
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Reckitt
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ratiopharm
SANOFI
Boehringer Ingelheim
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Heraeus
Takeda
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UMM
STORCK
Torrent Pharma
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We’re proud to be the quality partner for companies active in life sciences. From initial concepts to delivery to patients, our journey with each client is unique and driven by a commitment to excellence.
A German pharmaceutical company approached Zamann requesting support as they needed technical consultancy to ensure that the CSV documentation related to the Waters Empower system was 100% compliant with the required standards and references. Therefore, we proposed a complete documentation evaluation, considering that this GAP Assessment process would be essential to ensure compliance with FDA regulations and GAMP guidelines. We offered a clear, self-explanatory, robust and holistic assessment of the entire environment surrounding CSV, and expert recommendations for remediation through CAPAs (Corrective and Preventive Actions).
A mid-sized German pharmaceutical company specializing in the development and production of injectable drugs faced significant challenges in managing its Computerized Systems. The company needed to create a robust Computerized System Validation (CSV) framework to comply with GAMP5, FDA (21 CFR Part 11), and EU Annex 11 regulations. However, the absence of formalized processes and a lack of staff training on CSV principles posed risks to data integrity and regulatory compliance. The get in contact with Zamann Pharma Support to develop a structured CSV landscape, create all necessary SOPs, and train their staff to establish a culture of compliance and operational excellence.
A prominent German pharmaceutical company, specializing in advanced formulations and biotechnology, implemented a Laboratory Information Management System (LIMS) using Labware to optimize laboratory workflows and data management. The system was validated internally, but the company sought an expert review to ensure compliance with regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines.
A leading Indian pharmaceutical company sought to strengthen its data integrity framework by implementing a robust and compliant Audit Trail Periodic Review process. Although audit trail functionality was enabled on their computerized systems, they lacked the procedural framework and tools to ensure consistent periodic reviews, as required by regulatory authorities like the FDA, EMA, and PIC/S.
A leading pharmaceutical company specializing in biotechnology drugs for cancer treatment sought to enhance its Computerized System Validation (CSV) documentation processes. Due to the complex nature of their operations and the critical importance of regulatory compliance, the client needed a robust mechanism for reviewing CSV documentation to ensure quality, consistency, and adherence to industry standards such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
A nig pharmaceutical and vaccine manufacturer located in south Germany sought to address the burdensome amount of paper-based documentation generated in their quality control (QC) laboratories. Each batch of product samples required detailed logging of devices, eluents, and various other parameters for regulatory compliance. These repetitive tasks produced a massive paper trail each month, often leading to inefficiency, errors, and significant storage challenges.
A large pharmaceutical site faced difficulties migrating millions of datasets from an older Labware v5 system to a new Labware v8 platform. The transfer required a reliable approach to mapping, updating, and verifying legacy Master Data while ensuring that day-to-day operations in the lab remained unaffected. Zamann Pharma Support was brought in to design a plan that would manage the massive data extraction, align it with the new system’s configuration, and enforce a temporary “Master Data Freeze.” A structured backlog management system was introduced to handle ongoing Master Data changes without interrupting the validation timeline or the site’s operational workflows.
A mid-sized pharmaceutical organization sought to streamline its Labware LIMS operations by unifying multiple stages—validation, deployment, and ongoing run support—under one service provider. Previous efforts involved separate vendors for each phase, leading to fragmented communication and additional expenses. Seeking a single integrated model, they turned to Zamann Pharma Support. The goal was to maintain consistent processes, strengthen regulatory compliance, and reduce overhead by eliminating duplicated efforts between different teams.
A leading biotechnology company in Germany engaged Zamann Pharma Support (ZPS) to deliver Labware 8 training for their end users. Following the successful deployment, the client requested ZPS to document the training within Veeva, a regulatory-compliant content management platform. Despite a smooth training delivery, ZPS encountered challenges during the documentation phase in Veeva.
The migration aimed to align the client’s document practices with current regulatory standards while enabling efficient long-term storage and seamless access. The process required operating SOP Guard and Veeva Vault Quality in parallel, presenting unique challenges such as ensuring documents were not concurrently effective in both systems and maintaining compliance during the migration.
The client aimed to transition from manual demand management to an automated system, enabling greater efficiency, improved decision-making, and significant cost savings. ZPS leveraged its expertise in Jira, Confluence, and ServiceNow to design and implement a customized solution that automated workflows, enhanced reporting, and integrated demand management tools for a unified approach.
The client’s objective was to find a sustainable, cost-effective solution to manage TrackWise without compromising performance or compliance. ZPS proposed migrating TrackWise to AWS Cloud, highlighting its ability to reduce infrastructure costs, optimize application performance, and enhance security. The proposal also offered scalability to handle global operations and streamlined maintenance with self-managed cloud operations.
One of the largest healthcare providers partnered with Zamann Pharma Support (ZPS) to implement an advanced AI-driven predictive modeling solution. The client required a robust predictive analytics solution to improve patient care by identifying individuals at risk of adverse health outcomes. Leveraging AI and machine learning (ML), ZPS developed a system that analyzed vast amounts of patient data, predicting risk factors and guiding treatment plans.
The manual process of logging and managing complaints was cumbersome, time-consuming, and prone to errors, resulting in inefficiencies that impacted overall operations. To address these challenges, a German Pharmaceutical industry engaged Zamann Pharma Support (ZPS) to design a streamlined and automated solution.
A leading biotech company in central Germany was implementing a global eQMS system (TrackWise) across multiple sites and countries. Although they had a nominal “Key User” Management model in place, it was not functioning effectively. User acceptance remained low, and key users worked in silos without sharing best practices or learnings. This lack of coordination led to disjointed system usage, incomplete training, and recurring compliance challenges.
A global LIMS implementation project for a biotech pharma company required a comprehensive training concept to address varying levels of user knowledge. While some sites were transitioning from an older LIMS version, others were implementing the system for the first time, shifting from paper-based workflows to digital. Zamann Pharma Support was tasked with creating a tailored training solution to ensure smooth adoption and high user acceptance.
A project required collaboration across various departments within a multinational pharmaceutical company and external parties. The project aimed to harmonize efforts, overcome differing approaches to work, and streamline task execution through effective project management and communication.
A German pharmaceutical company approached Zamann requesting support as they needed technical and operational consultancy to ensure that their current technical and third-party quality agreements (TA and QTA) are reviewed and renewed. Therefore, we proposed a complete documentation update, considering German and European approaches, pharmacovigilance inclusion and global company harmonized approaches to ensure compliance with regulations and company guidelines. We offered a fast, robust and harmonized documentation renewal.
A global pharmaceutical company approached Zamann Pharma Support to provide expert guidance in segregating their Quality Management System (QMS) requirements to accommodate multiple business entities. These entities, spanning manufacturing, distribution, warehousing, and laboratory services, operated under differing regulatory and operational demands. Zamann Pharma Support proposed a tailored and systematic approach to align QMS processes with entity-specific needs while ensuring overall compliance with global and local regulatory requirements.
A German pharmaceutical company based in Heidelberg, partnered with Zamann Pharma Support to transition from a traditional paper-based training system to a robust electronic training management solution. The goal was to improve training efficiency, ensure regulatory compliance, and streamline record management processes in alignment with EU GMP requirements.).
A multinational pharmaceutical company approached Zamann Pharma Support to harmonize their Quality Management System (QMS) processes across various Standard Operating Procedures (SOPs) used by different entities. The goal was to create unified and consistent processes that ensured compliance with regulatory requirements while addressing entity-specific needs.
An industrial company based in Mannheim engaged Zamann Pharma Support to establish fundamental Quality Management System (QMS) standards. The client lacked a structured QMS framework, and their goal was to improve process control, ensure regulatory compliance, and enhance operational efficiency. Zamann Pharma Support provided a step-by-step approach to design and implement a customized QMS that met both industry standards and business needs.
A pharmaceutical company near Frankfurt in Germany, was commissioning a new pharmaceutical manufacturing building but faced significant challenges in getting the facility fully operational. Multiple runs were required—water runs, engineering runs, validation runs, and Process Performance Qualification (PPQ) runs. Each activity involved multiple departments and distinct procedures that had to be synchronized. The organization needed a structured plan that would accommodate everything from tech transfer and method validation to stability testing and process validation.
A German pharmaceutical company required a well-coordinated laboratory move to a newly built space to accommodate growing tasks and operations. The challenge was to ensure no interruptions to testing workflows, maintain full GxP compliance, and meet strict timelines without impacting lot release schedules. Zamann Pharma Support was engaged to plan and manage this transition, providing detailed organization, communication, and risk management.
A biotech pharma industry required the relocation of 30 analytical devices (such as LightCyclers, workbenches, centrifuges, etc.) to a new operational space. The relocation had to be executed with minimal downtime, ensuring that all equipment remained GxP compliant and operationally ready post-move. Zamann Pharma Support was brought in to plan, manage, and execute the equipment move while adhering to strict timelines and quality requirements.
A French multi-national Pharmaceutical Company required support in the Nitrosamines Project in describing a process for Sample Management and Batch sending Process. Defining the process for sample management and the batch sending process for drug products being tested for nitrosamines required clear, compliant workflows. These workflows must align with regulatory requirements (e.g., EMA, FDA, ICH) and internal quality standards.
A Swiss pharmaceutical company sought assistance in streamlining their expert assessment process for a Nitrosamines Project to address regulatory requirements efficiently. They needed support in coordinating cross-functional teams, managing complex data, and ensuring consistent evaluations across products. The focus was on establishing clear workflows, enhancing communication, and creating standardized tools to improve the accuracy and speed of the assessment process while maintaining compliance.
A multinational pharmaceutical company needed assistance establishing its Nitrosamines Project framework and implementing key performance indicator (KPI) tracking. This support involved defining project goals, creating standardized workflows, and developing tools for monitoring progress. With clear KPIs in place, the company aimed to measure effectiveness, maintain regulatory compliance, and continuously improve their processes.
A pharmaceutical company needed support in establishing a Confirmatory Testing Committee as part of their Nitrosamine Project, ensuring consistent and effective oversight throughout the testing process. They required guidance on defining the committee’s roles and responsibilities, selecting qualified members, and setting clear decision-making protocols. This involved creating a structured meeting schedule, standardizing documentation practices, and implementing a robust tracking system to follow up on action items. By seeking external help, the company aimed to gain transparency, maintain regulatory compliance, and ensure timely responses to any confirmatory testing results or recommendations issued by the committee.
