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Manufacturing QC & Product Release

As products progress from R&D to Manufacturing, the demands on informatics and business processes change. Zifo’s can support your tech transfer labs and plant operations with our services and product capabilities developed to meet the rigorous demands of compliance, validation and regulatory compliance in Tech transfer, Testing, CMC and Product Release.

analytical-testing

Assay development and validation, instrument data acquisition and integration, regulatory and QC data reporting, lab inventory and metrology, workflow automation and validation

batch-release

Process optimisation, automation, validation and QC through BPMN, technology and change management to automate business rules to support decisions and scale

data-integrity-compliance

CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP

In-vitro-In-Vivo_540_281

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.

lab-instrument-validation

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

managed-services

"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.

process-automation

Automated assay and screening, batch release, workflow orchestration, BPMN, low-code-no-code process automation (RPA) and robotics platforms.

quality-compliance

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