Validation you can prove
Track the qualification and validation state of every computerized system, with evidence mapped to GAMP 5 and CSA expectations so audits move faster.
Pharma & life sciences
Data integrity and GxP, continuously proven
Senissa connects to your validated systems, quality tools, and cloud to monitor GxP controls and data integrity around the clock. Evidence stays inspection-ready, and access to research and trial data stays tightly governed.
- ALCOA+ data integrity, evidenced
- 21 CFR Part 11 controls
- Validation state monitored continuously
How it works
From validation binders to a living quality record
Replace periodic reviews and screenshot folders with continuous checks across every GxP and computerized system you run.
Connect
Every validated system, in one control plane
Senissa integrates with the systems where your regulated data lives - LIMS, ELN, MES, QMS, eTMF, and the cloud and identity platforms behind them. Controls, configurations, and validation state are read continuously, not sampled once a quarter. Nothing depends on a coordinator chasing exports the week before an inspection.
- LIMS, ELN, MES and QMS
- Cloud, identity and code systems
- Validation state read continuously
Govern
Data integrity and access, watched in real time
Every record is checked against ALCOA+ expectations, so gaps in attribution, audit trails, or contemporaneous capture surface the moment they appear. Access to trial and research data is measured against least-privilege rules, with drift flagged and logged. When an inspector asks, the proof is already assembled and timestamped.
- ALCOA+ checks on every record
- Least-privilege access to trial data
- Timestamped, inspection-ready evidence
Built for regulated science
Compliance that keeps pace with GxP
One platform for the frameworks and data-integrity rules that govern drug development, manufacturing, and clinical research.
Guarded research data
Govern who can reach clinical, trial, and IP-sensitive datasets, and get alerted the moment access drifts from policy.
Part 11 evidence
Electronic records and signatures, audit trails, and access reviews are collected and organized to satisfy 21 CFR Part 11 and EU Annex 11.
Ready for your next inspection?
See how Senissa keeps GxP evidence, data integrity, and access governance continuously audit-ready.