INTEGRA: Stringent Paperless Process Documentation for Media Preparation Labs

INTEGRA has announced that its MEDIACLAVE 10/30 media preparation systems have been upgraded to provide all the necessary tools to support the most stringent process documentation and validation needs.

More and more laboratories rely on electronic process documentation to avoid costs associated with paper use and excessive storage space requirements. However, laboratories must also ensure that their electronic process documentation comply with regulatory requirements. According to FDA (21 CFR Part 11) and EU (GMP Annex 11) protocols, electronic process file must be verified with a digital signature.

New generation MEDIACLAVE 10/30 systems now provide the feature of digitally signed log files as a safeguard against tampering with downloaded files. The signed log files fully comply with FDA (21CFR Part 11) and EU (GMP Annex 11) directives requirements for electronic process documentation.

A newly integrated USB port on MEDIACLAVE 10/30 systems allows the automated transfer of all run data log files to a flash drive. Saving and managing process data has never been so easy. Furthermore, MEDIACLAVE 10/30 systems are equipped with Ethernet connection, allowing connection to a PC, LAN or easy integration with LIMS. As a consequence run log files can be easily and simply transferred and archived to a personal computer or data storage device of your choice.

For further information please contact INTEGRA on +41-81-286-9540 / +1-603-578-5800 or info@integra-biosciences.com.  

INTEGRA Biosciences is a leading provider of high-quality laboratory tools for liquid handling, media preparation, sterilisation and cell cultivation. The company is committed to creating innovative solutions which fulfil the needs of its customers in research, diagnostics and quality control within the life science markets and medical industry. Today, INTEGRA innovative laboratory products are widely used all around the world. More than ninety distribution-partners form a worldwide sales network providing responsive and competent services to customers. These distribution partners are supported by a highly motivated and experienced team of specialists at the company headquarters in Zizers, Switzerland and Hudson, NH, USA.  INTEGRA is an ISO 9001 certified company.

 

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Worldwide HQ

INTEGRA Biosciences AG
Zizers, Switzerland

Tel: + 41 81 286 9530
Email: info@integra-biosciences.com
www.integra-biosciences.com

 

USA

 

INTEGRA Biosciences Corporation

Hudson, NH 03051

USA

 

tel. +1 603 578 5800

Email: loneil@viaflo.com

www.integra-bioscience.com