Regulatory Compliance
Sciency fully meets the requirements for GxP and 21 CFR Part 11 by providing administrator definable access control, granular audit trails and electronic signature sign offs.
Sciency is compliant with the following standards:
- FDA 21 CFR Part 11
- GLP/GMP (Good Laboratory Practice and Good Manufacturing Practice)
- Section 508 Accessibility Guidelines
Sciency ensures compatibility with:
- Business Process Execution Language for Web Services (BPEL4WS)
- Standardized vocabularies, ontology and other structured nomenclature
- NCI Thesaurus (NCIt)
- LOINC (Logical Observation Identifiers Names and Codes)
- RadLex (Radiology Lexicon)
- SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms)
- MedDRA (Medical Dictionary for Regulatory Activities)
