Instem - Information Solutions For Life

Solutions

• Provantis
• Genetic Toxicology
• Submit SEND solution
• Toxicology Resource Planning
• Information Management
• Regulatory

Instem recognizes that the management of quality during the software development process is not only desirable from a business perspective but complements international regulations.

We were one of the first...

We were one of the first software companies to achieve the international quality standard ISO9001 and we have maintained this leadership position with early accreditation to ISO9001:2000. Close global links with the industry’s regulators keep our solutions at the forefront of regulatory compliance. Instem has taken a leading role in ensuring compliance with the FDA’s regulations from the Red Apple workshop in the 1980s to providing the first solution in the market to support the FDA’s SEND initiative, which introduced new standards for submitting and viewing electronic study data.

Since 1997 Instem has taken a leading role in ensuring compliance with the FDA’s regulations covering Electronic Records and Electronic Signatures (21 CFR Part 11). Together with The User Group (TUG -a coalition of Provantis users throughout the world) we continually review how we can assist customers to comply with Part 11 and where the most benefit could be achieved in the shortest time-scale.

Today, our systems are used to submit dossiers to regulatory bodies around the world. We have led the industry in our levels of investment in R&D and in our development and deployment methodology. That is why customers consistently benefit from on-time delivery of product releases; something almost unique in the IT sector.

For further information please contact us at regs@instem-lss.com