Faster and Safer CMC Development

Quality by Design was built to bring science and structure to process development, yet most teams still juggle scattered files and one‑off templates. The result: inconsistent data, duplicated effort and delayed deliverables.

The ValGenesis Process Lifecycle Suite changes that equation. It unifies every QbD element - CQAs, CMAs, CPPs, risk assessments and control strategies - inside a single, database‑driven platform so you can design, justify and scale processes without the downstream surprises.

With ValGenesis Process Lifecycle Suit you can expect:

• End‑to‑end QbD workflows – guided yet flexible templates standardize how teams define CQAs, map CPPs and document rationale.
• Automated risk assessments & reports – generate FMEA, HACCP and other analyses in a click, complete with up‑to‑date heat maps and charts.
• Central knowledge base – capture process learnings once and re‑use them during scale‑up, tech transfer and commercial monitoring.
• Integrated data integrity – controlled access, e‑signatures and full audit trails ensure decisions are traceable and inspection‑ready.
• Real‑time insight – compare risk scenarios side‑by‑side, update control strategies instantly and push changes downstream without re‑keying data.