As we continue our busy schedule, we are now attending Pharma 2024 in Barcelona, hosted by Reuters Events Pharma, for the next two days. This event brings together over 1,200 top professionals from across the pharmaceutical industry, including experts in commercial, marketing, medical affairs, patient engagement, market access, real-world evidence, and digital health.
The client sought to validate two modules within a new system, P4Labs, developed to meet specific company requirements (GAMP 5 category). The modules included:
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.
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 …
eCValidation at XV Spring Pharmaceutical Conference BMP Read More »
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!
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,
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 …
eCValidation at Europe’s Premier Independent Healthcare Conference for Life Sciences Read More »
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 …
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.
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.
We provide comprehensive and goal-oriented quality services for companies in regulated industries and beyond. We handle everything from step one and deliver more than you expect. On time.
Contact
Aleje Jerozolimskie 195B
02-222 Warszawa
ecvalidation is a team of experts specializing in validation and qualification services of software, equipment, installations, rooms and processes.