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Built for Quality without compromise
Quality is imperative throughout the entire development, validation, and final release testing of any therapeutic product. Often involving many complex and multifaceted challenges, vendors have a responsibility to ensure that their products meet defined criteria to deliver reliability and peace of mind to the end user.
We have partnered with SelectScience® to bring you this discussion about how a modern chromatography data system (CDS) can provide a secure software platform from its early design, offering all the tools you need to maintain the integrity of your data, while alleviating concerns associated with regulatory audits.
Key learning objectives
- Learn how CDS is devised from initial design to final product
- Discover how technical controls can help drive quality and streamline operations
- Find out how CDS can make compliance easier, and how to prepare for the inevitable audit
Who should attend
- CDS power users
- Laboratory managers
- Quality Assurance professionals
Deliver assurance and product quality with your CDS
Software design and development require a solid approach to methodology and testing to deliver a product that meets end user requirements for performance, stability, and quality. The directions taken will often follow a specific model to confirm that the product is fit for use and of high manufactured quality.
Key learning objectives
- Find out how a CDS is devised from initial design to final product
- Discover how features are tested to ensure high specification
- Learn about the validation model used for software product development
About the presenters
Simon Hoffmann
Senior Manager, Software Development
Thermo Fisher Scientific
Vera Zimmermann
Senior Manager, Software Test Engineering
Thermo Fisher Scientific
Resources
Using innovative compliance tools to ensure data quality and integrity
Accurate and reliable analytical results are paramount to producing safe therapeutic products with high efficacy, while adhering to changing regulatory guidelines remains a constant challenge.
In this online seminar we will demonstrate how you can drive data quality using the comprehensive compliance tools in Chromeleon CDS to provide data integrity, ensuring that records are accurate and consistent, with advanced tools to detect suspicious activity.
Key learning objectives
- Discover how technical controls can help drive quality and streamline operations
- Find out how you can effectively and efficiently interrogate your data
- Learn how a CDS can make compliance easier
About the presenter
Peter Zipfell
Product Marketing Manager
Thermo Fisher Scientific
Resources
Ensuring system quality to deliver easier audits
Any lab operating in a regulated industry can be subject to a compliance audit. System qualification and validation is an important part of being prepared for this. With careful planning you can mitigate the intense scrutiny that could be faced from a meticulous auditor.
In this webinar we will explain how Thermo Fisher Scientific and Chromeleon CDS can help you with system quality to ease the burden of an inspection, which in return delivers audit confidence without major citations.
Key learning objectives
- Find out how you can prepare for the inevitable audit
- Learn about current regulatory requirements and what this means for your lab
- Discover expert hints and tips for system review
About the presenter
Patrick Kenny
Software Compliance Product Manager
Thermo Fisher Scientific
Resources
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