Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
Act by which an authoritative body grants a credit or recognition to an institutional body or person competent to carry out specific tasks maintaining guidelines for quality standards.
An organization or agency authorized to inspect a facility and provide written evidence of its compliance (certification) and competence (accreditation) with a standard.
Systematic, independent and documented verification process of LIMS sample data.
Audit trails are documented evidences to series of activities occurring at any given point of time, specific operation or event ever since they are first recorded. As part of 21 Code of Federal Regulations Part 11 (21 CFR Part 11), it's a mandate for diagnostics, biobanks and CROs to preserve their records in chronological order for traceability purposes. Information recorded in the audit trail typically includes operator code, case number, amount and quantity prior to change, notes etc.
A system managing tracking of bills for consumables/ reagents and financial transactions such as payment processing, quotes, expenses within a LIMS set-up.
A system that ensures efficient tracking of biospecimen lifespan, from its receiving, storage, tagging their physical and clinical annotations while processing, associating physical locations till its final disposition.
A biorepository which includes a large collection of biological data and tissue samples for research purposes.
Prevention or maintenance check on safety conditions for microbial contamination, their integrity, infection or toxic reaction leading to hazardous incidents to protect humans and environment.