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Case study for computer system validation

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Registered in England and Wales. Number The dynamic duo is back, leading the way and bringing together the quality and validation community for updates, strategies and comprehensive takeaways. Live interactive content and on-demand sessions to view at your convenience, plus all content available for 30 days post-event to view at your leisure. You will benefit from attending this event if you are a professional at a pharmaceutical , biotech or medical device manufacturer with responsibilities in the following areas:.
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Greenlight Guru Medical Device Blog

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Computer System Validation (CSV) Efficiency & Governance | Case Study | Arbour Group

This Training Course has unfortunately already taken place. Therefore, registration is not possible any more. However, recordings are available for many courses, which you can order and view at any time. You will find these recordings in a list sorted by topic. Of course you can also use the following contact form to send us your request. If you have any questions, please contact us: Tel. Learn how to plan validation verification activities, leveraging the expertise of your supplier Learn how to minimise duplication of effort between the supplier and your regulated company in order to achieve lean and effective processes throughout the system life cycle Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship Computerised Systems Validation Master Class: As a specialist for the validation of computerised systems, this Live Online Training will provide you with Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA Computer Software Assurance can be put into practice Real-life examples of how validation effort can be scaled according to risk-based approaches Answers to specific questions, e.
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MHRA Blog - Computer Systems Validation (GCP)

Drug and medical device manufacturing in the modern world relies increasingly on computerized systems. Being highly regulated industries, ensuring quality and accuracy of data is paramount; and thus, Computer System Validation CSV is necessary to assure that critical processes are functioning properly. Many regulated companies, however, still use unvalidated computer systems. Computer System Process Validation Process validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process a product, a service or other outcome can be practically guaranteed.
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Axteon is a technology company that provides innovative solutions in the field of computerized systems validation, software development services, and source code escrow. Axteon specializes in the validation of computer systems for the pharmaceutical and biotechnology industry, widely referred to as Life Sciences. Axteon provides a deposit solution for IT source code escrow, license key escrow. We have extensive knowledge in the field of IT programming, IT architecture, IT infrastructure including cloud computing supported by experience in concluding IT agreements in Central and Western Europe Benelux countries.
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