Any company manufacturing drug products, biologics or medical devices must follow current Good Manufacturing Practice (cGMP) regulations. These regulations ensure that medical products are safe and effective for patients and consumers. cGMP regulations are enforced by a number of regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
cGMP regulations include minimum standards for all facilities, equipment, processes and quality management systems used to manufacture medical products. LabTwin’s voice-powered digital lab assistant can help companies comply with cGMP requirements, by allowing staff to accurately record manufacturing conditions and processes, in real-time, from anywhere within manufacturing facilities.
Better Record Keeping with Full Audit Trail
Unlike ELNs, LIMS and MES software, LabTwin’s digital lab assistant allows real-time data collection by directly communicating with lab equipment, as well as instantly transcribing voice notes. LabTwin lowers data transcription error rates because data are automatically collected at the point of experimentation, with time stamps and electronic signatures.
Easier Validation of Equipment and Processes
With LabTwin’s digital lab assistant, scientists can make real-time data-driven decisions when validating equipment and processes. Instant access to data makes it easier to trouble-shoot methods and ensure that equipment and processes perform within acceptable limits.
Automated Equipment Maintenance
LabTwin can automatically connect to lab instruments, making it easy to monitor equipment calibration. The digital lab assistant can also remind staff of essential equipment maintenance schedules to maintain optimal function.
Streamlined SOP Management
Scientists can access SOPs by voice commands with LabTwin’s voice-activated digital lab assistant. LabTwin can also dictate SOPs step-by-step to scientists and record protocol adherence, thus improving compliance and facilitating auditability. The digital lab assistant also makes it easy to update protocols in real time, and record any protocol deviations, thus ensuring that all staff use the most up-to-date and validated SOPs.
Facilitated Staff Training and Competency
The digital lab assistant can identify users and track use of SOPs and other training documents. These features make it easy to record staff training and monitor staff competency.
LabTwin makes it easier to record and manage data for all aspects of manufacturing. This results in improved record keeping with complete traceability. Combined with time stamps and electronic signatures, this provides a full audit trail.
Any manufacturer wishing to market medicines or drug products within the U.S or the E.U. must comply with cGMP regulations. LabTwin’s voice-activated digital lab assistant helps with cGMP compliance by allowing companies to accurately record data and manufacturing conditions. With LabTwin, companies can manage equipment and process validation, SOP compliance, staff training and quality control processes.
U.S Food and Drug Administration Current Good Manufacturing Practice (CGMP) Regulations (Online) Accessed April 30, 2020 at https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
U.S Food and Drug Administration Facts About the Current Good Manufacturing Practices (CGMP) (Online) Accessed April 30, 2020 at https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
U.S. Food and Drug Administration Quality System (QS) Regulation/Medical Device Good Manufacturing Practices (Online) Accessed April 30, 2020 at https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
European Medicines Agency Good Manufacturing Practice (Online) Accessed April 30, 2020 at https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice