Client Cases
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.
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 prominent pharmaceutical company initiated the rollout of LabWare 8 across its Quality Control laboratories. This implementation was part of a broader effort to enhance data integrity, reduce manual errors, and support GxP-compliant workflows. The company identified the Method Execution (MethEx) module as a critical element in their LIMS digitalization strategy.
Zamann Pharma Support was engaged by a multinational pharmaceutical company (German facility), to lead a critical validation project step, related to the implementation of Labware LIMS 8 at one of their German manufacturing sites.
A leading global biopharmaceutical company planned a rollout of new version of a LIMS system trainings developed centrally in English. At its German site, however, a separate local training system in German was already in place, aligned with national regulatory expectations.
Pharmaceutical laboratories execute countless repetitive analyses every week. Often, identical instruments, reagents, and standards are used across multiple lots. However, in many organizations, analysts still prepare each lot separately in LIMS and re-enter the same data repeatedly.
A global pharmaceutical company implemented LabWare 8 across multiple sites. Meanwhile, headquarters designed a unified training concept based on e-learnings, generic role models, and high-level workflows. However, this approach followed a strict “one-size-fits-all” logic.
In many GMP-controlled QC environments, teams operate a standalone Environmental Monitoring (EM) system alongside LabWare LIMS 8. At first, this setup appears functional and practical. However, over time, operational complexity increases across validation, infrastructure, and data reconciliation.
The pharmaceutical industry is under increasing pressure to produce safe, high-quality medicines faster, more cost-effectively, and with full regulatory compliance.
Environmental Monitoring (EM) is one of the most critical and resource-intensive activities in pharmaceutical cleanrooms. Every contact plate, settle plate, swab, and record must meet strict GMP requirements while maintaining full traceability.
A pharmaceutical manufacturing site approached Zamann Pharma Support to understand the hidden risks created by different levels of digital maturity across production areas.
A global pharmaceutical company used Veeva Vault QMS to manage deviations, CAPAs, and change controls.
Over time, teams added product structures, device hierarchies, stability data, and manufacturing details. Consequently, Vault started to replace functions that belonged to ERP, LIMS, and MES systems
Stability management looks straightforward: define the protocol, create the study, schedule sample pulls, perform testing, review trends, and prepare reports. However, daily operations often reveal a different reality.
A high-value injectable batch on Line 3 is nearly complete. MES shows that production is close to completion. Therefore, operators start discussing the next campaign, while the supply chain team pushes for batch release.
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 pharmaceutical company operating a German production site faced a recurring challenge during a global system rollout. The global project team had prepared a comprehensive training package in English and deployed it across all sites. However, at the local level, the situation was different.
A German pharmaceutical manufacturer asked Zamann to strengthen its Equipment Qualification compliance. At first, the project appeared to involve technical weaknesses, including incomplete documentation, weak protocols, and missing Design Qualification records.
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 operating a newly built plasma fractionation facility approached Zamann Pharma Support due to an increasing backlog of deviations. The facility had implemented stringent specifications for media, environmental monitoring, and manufacturing processes—especially for plasma fractions—which led to a high number of complex deviations.
In sterile pharmaceutical manufacturing, small operational deviations can quickly escalate into serious compliance risks. One of the most frequently underestimated areas during FDA inspections is vial reject handling during filling operations, especially in media fill studies.
Pharmaceutical companies increasingly need alternative API suppliers because of supply disruptions, cost pressures, and portfolio growth.
However, API supplier qualification now requires more than GMP certificates and audit reports.
Line clearance often appears to be a basic GMP activity. However, one leftover label can show that the entire control process failed.
In an anonymized packaging scenario, the previous batch used Product A labels. Some labels fell into a scrap tray.
A newly funded medical device startup had successfully proven its technology concept but lacked the internal resources to navigate the complexities of Quality Management, Regulatory Affairs, and Technical Documentation. Building a robust Quality Management System (QMS) from scratch would have diverted precious time and funding from core product development. Instead, the company chose Zamann Pharma Support’s “Quality as a Service” model, which allowed them to join Zamann’s existing QMS framework within two months.
A well-known IVD consumer product in Europe suddenly became the target of a competitor’s lawsuit, forcing its manufacturer to urgently revise the product’s marketing strategy, packaging, and labeling. Any delay in supplying this product could have led to a significant drop in market share. Given these high stakes, the company sought immediate assistance from Zamann Pharma Support.
A global medical device company in Northern Germany faced a critical need to update its product documentation to comply with the new Medical Device Regulation (MDR), replacing the older Medical Device Directive (MDD). Recognizing the potential impact on product registrations, labeling, and post-market activities, they turned to Zamann Pharma Support for assistance. The project involved evaluating all existing technical documentation and formulating an action plan to align those documents with MDR standards.
During a project in a South American pharmaceutical company, the team validated the purified water (PW) system three years earlier and released it for operation. However, they did not perform any structured periodic reassessment after the original qualification.
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.
During a project, Zamann supported a German pharmaceutical company to strengthen CSV compliance with EMA and FDA expectations. However, the team identified a common and risky assumption. The company believed that a system remains valid because it was validated years ago.
Purified Water systems do not usually fail because of equipment; instead, they degrade silently due to biofilm formation, weak loop design, and missing microbial trending.
Environmental Monitoring (EM) plays a critical role in pharmaceutical, biotechnology, and medical device industries. Therefore, organizations depend on systems like LabWare 8 EM Planner to define sampling frequencies, assign sampling points, and generate structured schedules.
When Zamann Pharma Support started working with a German pharmaceutical manufacturer, the request initially focused on improving compliance with FDA and EMA requirements for Equipment Qualification.
However, after deeper analysis, a critical issue became visible. In reality, the core problem was not the qualification system itself. Instead, the organization continuously implemented changes on already qualified equipment without properly evaluating their impact on the validated state.
A German pharmaceutical company engaged Zamann Pharma Support to strengthen compliance of its Equipment Qualification (EQ) system in line with FDA and EMA expectations.
However, during the initial assessment, Zamann identified a critical issue.
When Zamann engaged with a German pharmaceutical manufacturer to improve compliance with EMA and FDA expectations for Equipment Qualification (EQ), a critical issue surfaced immediately. The company lacked reliable data integrity controls within the qualification lifecycle.
A German pharmaceutical company approached Zamann Pharma Support to strengthen compliance around the Waters Empower-related CSV and surrounding validation environment.
A German pharmaceutical manufacturer engaged Zamann Pharma Support to strengthen compliance in Equipment Qualification (EQ), specifically around Waters Empower CSV documentation and lifecycle controls.
A German pharmaceutical company approached Zamann requesting support to strengthen CSV compliance with EMA and FDA expectations.
Many pharma QC labs trust their LabWare setup because “we’ve never had a serious finding.”
However, regulators do not evaluate historical comfort. Instead, they assess the current control state of computerized systems.
Lot release is the most critical step in pharmaceutical quality management because it determines whether a batch is safe for patient use. However, across the industry, deviations still occur where lots are released without full review and approval of all underlying samples or tests, creating serious compliance and data integrity risks.
A pharmaceutical organization planned to upgrade its Laboratory Information Management System (LIMS) from LabWare 7 to LabWare 8. Initially, the migration was considered a routine technical upgrade because both versions belonged to the same software family.
In many global pharmaceutical companies, SAP Quality Management and LabWare LIMS should operate as one connected quality system.
SAP creates an inspection lot for a specific material and batch. Next, the interface transfers the inspection information to LabWare. Laboratory analysts then perform the required tests and record the results.
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.
A pharmaceutical company approached Zamann Pharma Support because they needed a cost-effective and compliant strategy to manage nitrosamine risk assessment for their drug products.
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In 2024, the European Medicines Agency updated its guidance on nitrosamine impurities. The update revised several Acceptable Intake values, expanded the list of N-nitrosamine drug-substance-related impurities, and introduced stricter expectations for risk assessment…
