Software helps ensure regulatory compliance
Bensalem, Pa. -Stelex, a regulatory compliance consulting and solutions provider, recently introduced ComplianceBuilder, a patent pending technology for creating a secure, central archive database for all documents related to regulatory compliance. ComplianceBuilder is designed to address each section of the FDA's 21 CFR Part 11 regulation on electronic records and signatures and is available in two versions. ComplianceBuilder/File version is designed for instrument data files, datasets, Microsoft Word and Excel, or other document formats. ComplianceBuilder/SCADA is designed to interface with PLCs, DCSs, SCADAs, and MESs using OPC or vendor specific Com-plianceBuilder interfaces.