Are your systems 21 CFR Part 11 compliant?
Scientific Solutions “R” US can help with onsite assessment and compliance. SSRUS offers comprehensive packages based on onsite assessment that will bring all laboratory systems to current compliance standards saving money and regulatory citations.
Laboratory Equipment Qualification (Computerized Systems) – Computerized systems may simplistically be considered to exist as three main types of applications; process control systems, data processing systems (including data collection/capture) and data record/ storage systems. There are links between the three types of systems, described also as ‘interfaces’. The regulated user should be able to demonstrate through validation evidence that they have a high level of confidence in the integrity of both the processes executed within the controlling computer system and in those processes controlled by the computer system within the prescribed operating environment. We also lead and support SAP and ORACLE based systems.
Scientific Solutions “R” Us can help! Due to decades of experience and the high
intelligence level of the SS”R”Us team of professionals, we are able to make
complex subject matters easy to comprehend. Scientific Solutions “R” Us
understands that training is not enough and that is why we guarantee continued support
from our Experts onsite for as long as you need until you the Solution you desire. We offer “Virtual Validation” support 24 hours a day, 7 a week. Join our online Validation Club, where you will receive weekly updates on new regulatory initiatives, documentation tips, equipment recommendations and referrals, troubleshooting tips, etc. Join our Validation blogs where industry professionals all over the world meet and exchange ideas and experiences. Share the pains of validation and gain tips and answers from peers through shared experiences. Contact Us today for your free validation tip! Follow Us on Facebook, Twitter, and LinkedIn.