Twist2, a newly founded small Shanghai based company, released KMS 1.1 and LIMS-On-Demand 1.1 framework today. The new module added into Twist2 KMS and LIMS is mainly for compliance with American FDA CFR 21 Part 11 Regulation. Major requirements of FDA CFR 21 part 11 are electronic signatures, audit trails, and long-term archiving. This new module is incorporated within the routine workflow to generate the critical information required by research, development and production.

Documents in Twist2 LIMS-OD, KMS can be digitally signed using key-pair encryption (public and private keys). Once signed, these documents can't be modified. Any modification to files after signing will be reported. Multiple users can sign a doucument (e.g., researcher and supervior) after minor customization and configuration to guarantee and validate their authenticity.

 

Background on Twist2 Inc.,

Twist2 is located in the heart of the Shanghai Zhangjiang High-tech Park , which is renowned as the "Pharmaceutical Valley" in China. Our team includes leading scientist, information technology experts and business professionals.

Twist 2' s mission statement is to help local Life Science Industry accelerate lead discovery process, increase productivity, and improve management efficiency through our customized solution. With extensive experience and in-depth understanding in both life science and informatics, we are pleased to ensure that we are able to integrate our solution to customer's specific environment and deliver our solution on time, on budget, and on target.

For more information, please contact: Michael H. ZHAO, info@twist2.com or call 86-21-68562206