How eCValidation delivered efficient Computerized System Validation (CSV) results
The client sought to validate two modules within a new system, P4Labs, developed to meet specific company requirements (GAMP 5 category). The modules included:
How we assisted our client in re-validating their clinical testing management system
The client’s objective was to re-validate their clinical testing management system, comprising multiple modules. Following an audit deviation and the outcome of the periodic review, the client aimed to attain a verified state of the system, aligning with legal requirements and best practices.
eCValidation at XV Spring Pharmaceutical Conference BMP
We are attending the XV Spring Pharmaceutical Conference BMP, focused on Efficiency and Optimization. As the pharmaceutical industry continuously adapts to evolving factors such as geopolitical shifts, quality demands, and access to active ingredients, experts at the conference will address these challenges, sharing insights and proven strategies. The event brings together industry professionals to explore …
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CEBioForum 2024
We’re pleased to be part of CEBioForum 2024, an event focused on driving advancements in the Polish biotech-pharma sector, improving diagnostics, and pioneering new therapies. This forum provides an excellent opportunity to connect with industry leaders and gain valuable insights into the future of biotechnology. We look forward to catching up!
How we assisted our global customer with thermal mapping in a factory in Switzerland
Our primary task was to assist the client in meeting deadlines for qualifying approximately 40 devices. The objective was SIP* Cycle Development (CD). The plan was to provide documented evidence that the SIP process could fulfill the defined acceptance criteria,
eCValidation at Europe’s Premier Independent Healthcare Conference for Life Sciences
We are excited to be part of DIA Europe 2024 in Brussels, Europe’s leading independent healthcare conference for life sciences professionals addressing today’s most significant challenges. DIA Europe 2024 is centered around sustainability, innovation, and collaboration, covering a broad range of topics from the environmental impact of pharmaceuticals and the drug development process to building …
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eCValidation at DIA Europe 2024
In just one week, we’ll be attending DIA Europe 2024 in Brussels! We would love for you to join us at our presentation in Innovation Hub 2. Topic: Advancing Regulatory Practices and Pharmacovigilance through Industry 4.0: A Detailed AnalysisSpeaker: Michał Timler, Director of Validation Business Unit Overview: The adoption of Industry 4.0 technologies within the …
How GMP implementation made our client stand out in the market
The client aimed to achieve the best GMP standard for spirits production in Europe. Their goal was to differentiate themselves from competitors based on quality assurance, ensuring that customers would choose their products even in the face of slight price differences.
How did we drive compliance improvement for our global Norwegian client?
Operating within the European market, our client must adhere to EU regulations while also preparing for inspections from international bodies such as the United States Food and Drug Administration (FDA). Their validation processes lacked comprehensive documentation.
Implementation of GMP requirements in industries outside the pharmaceutical sector
The implementation and maintenance of the GMP system is a highly challenging, time-consuming, often tedious, and demanding task. It is so burdensome that most individuals working within this system would respond negatively to the question of whether to implement even elements of GMP if it is not directly required by law. The topic is very …
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