Assay development and validation, instrument data acquisition and integration, regulatory and QC data reporting, lab inventory and metrology, workflow automation and validation
Process optimisation, automation, validation and QC through BPMN, technology and change management to automate business rules to support decisions and scale
Automated assay and screening, batch release, workflow orchestration, BPMN, low-code-no-code process automation (RPA) and robotics platforms.
"Always on", end-user support, proven scale, quality, processes and knowledge of scientific applications have a measurable impact on end-user efficiency, satisfaction and application downtime.
Aggregating and ensuring the regulatory integrity of information for specifications, manufacturing process control parameters, stability parameters and analytical test variance data.
CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP
Early Pharmacology, ADME, Assay Automation, PK/PD, Assay Development & Validation, Bioanalysis, Inventory Management etc. and the linked regulatory aspects of GLP and IND/NDA/BLA creation support.
Instrument validation strategy, IQ, OQ, PQ qualification, risk-based approaches, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all analytical instrument hardware platforms
New quality system design/delivery/maintenance, auditing against regional regulatory guidelines (21CFRpart11, GLP, GMP, GCP, GAMP5), quality system audit and recommendations, quality system best practice adoption
Study design (DoE) and planning, sample tracking and pull date scheduling, environmental monitoring, sample testing and analytical test results capture, study results aggregation, validation, statistical analysis
Handover of analytical testing processes, manufacturing process parameters, product specification data transfer, data integrity support, validation & compliance, manufacturing plant design