Built for regulated pharmacovigilance
PVgenix is engineered around GxP, GAMP 5, and 21 CFR Part 11 — pairing the security controls, audit traceability, and validation documentation that regulated safety operations expect with a continuously-monitored, fully-managed platform.
Three layers, one connected case record
Regulatory alignment, data security, and end-to-end traceability work together so every regulated action is permitted, protected, and provable.
- 21 CFR Part 11 — electronic records & signatures
- EU GVP modules for pharmacovigilance obligations
- GAMP 5 computerised-system validation lifecycle
- GxP operational compliance throughout
- Role-based access control with least-privilege design
- Tenant isolation — logical for SaaS, physical for dedicated
- Encryption in transit (TLS 1.2+) and at rest (AES-256)
- Secrets management for credentials & keys
- Full audit logging — every create / read / update / delete
- Detailed audit trail — who, what, when, before / after
- Tamper-evident logging with a hash-chained record
- Electronic signatures captured & verified
A complete GAMP 5 evidence set, ready for your qualification
PVgenix ships with the full computerised-system validation lifecycle — specifications on the way down, qualification on the way up, and a Requirements Traceability Matrix linking every requirement to its proof.
The validation V-model
Each specification on the left is verified by a matching qualification on the right; the RTM (dashed) maintains the trace.
PVgenix is validation-ready and audit-ready: it ships with a complete IQ/OQ/PQ documentation package to support client-led validation. "Validated" is a state achieved only after qualification is executed in a specific client environment.
Bright Infonet develops and delivers the software, environment setup, and supporting documentation. The client and their qualified PV personnel own PV decisions, regulatory interpretation, validation execution, and compliance obligations.
Every action recorded, every record provable
Each create, read, update, and delete is written to an append-only audit trail. Entries are hash-chained, so any retroactive change to history breaks the chain and is detectable on inspection.
Field-level diffs capture the prior and new value of every changed attribute, with the acting user and UTC timestamp.
Each entry embeds the hash of the one before it, making the log verifiable end-to-end during an inspection.
Signed actions capture meaning, signer identity, and timestamp — bound to the record and re-verifiable.
Least-privilege, enforced by role
Roles grant only the permissions a function requires. Every grant is configurable per tenant, and every change to a role is written to the audit trail.
Clear lines between platform and PV ownership
Bright Infonet delivers and operates the software; your qualified PV personnel own the regulated decisions. Knowing where each line sits is itself part of an audit-ready posture.
We build & operate
- Platform software development & continuous delivery
- Cloud-native hosting, environment setup & patching
- Security controls, encryption & 24/7 monitoring
- IQ/OQ/PQ package & SOP templates for validation
You decide & validate
- PV decisions & regulatory interpretation
- Validation execution in your environment
- Compliance obligations & regulatory reporting
- User access governance & SOP adoption
Review the compliance posture with our team
Request a demo to walk through the security controls, audit trail, and documentation package with your QA / CSV team.