Process and analytical method development - easier, faster, and less expensive with Valgenesis iCMC™

What's in it

This data sheet gives a clear view of what ValGenesis iCMC™ does across process and analytical method development, including the workflows, tools, integrations, and compliance features you can expect.

What you’ll find inside

• Process and product definition capabilities like QTPP definition, process mapping, CQA identification and assessment, CPP analysis, process knowledge analysis, and causality/correlation analysis.

• Risk assessment and analysis toolbox including methods such as PHA, FMEA (D-FMEA/P-FMEA), HAZOP, HACCP, fault tree analysis, Ishikawa diagram, cause-effect matrix, decision trees, and control strategy and CCP assessments.

• Qualification and validation support across the lifecycle, including IQ/OQ/PQ-related activities and items such as URS, equipment risk assessment, FDS, IOPQ, and validation plans.

• Reporting and documentation with custom reports, versioning, audit trails, flexible layouts, a document repository, and conclusions for review and approval.

• Knowledge and data management through a knowledge base, master data lists, and a template manager.

• Compliance and data security overview covering audit trails and support for expectations such as 21 CFR Part 11 (e-records/e-signatures), 21 CFR Parts 210/211, EU Annex 11, ICH Q2/Q8–Q14 items listed, GAMP 5, ALCOA+, and several ISO standards noted in the sheet.

Who this is for

• CMC leaders and CMC program owners

• Process development scientists and engineers

• Analytical method development leaders

• MSAT and technology transfer leads

• Quality Assurance and Quality Systems teams

• Validation and CSV/CSA leaders involved in development-to-commercial handoffs

• Regulatory Affairs and CMC regulatory teams supporting submissions

• Manufacturing and technical operations leaders who need consistent transfer packages and visibility

• IT and digital quality leaders supporting integrated systems and access controls

What it helps with

• Provides feature coverage, workflows, and the toolset in one place

• Supports procurement and internal reviews with integration, scalability, security, and compliance details