Pharmacovigilance systems
Implementation and configuration of safety databases, case intake, signal management and periodic reporting workflows.
Systems integration · Life sciences
Complex pharma software, implemented right the first time.
We design, integrate and validate the enterprise platforms that pharmaceutical companies rely on for drug safety, regulatory compliance and quality — from first requirements to inspection-ready go-live.
Built for regulated environments
21 CFR Part 11EU Annex 11GAMP 5ICH E2B(R3)GxP
What we do
One partner for the systems your compliance depends on.
Pharmaceutical software is rarely a single product. It is a chain of databases, gateways, workflows and integrations that must work together — and stand up to regulatory scrutiny. We take ownership of that whole chain.
Regulatory submissions
E2B(R3) electronic transmission, gateway connectivity and regulatory information management integrated end to end.
Computer system validation
Risk-based validation aligned with GAMP 5 — validation plans, traceability, IQ/OQ/PQ and audit-ready documentation.
Enterprise integration
Connecting safety, quality, clinical and ERP platforms through secure, monitored interfaces and APIs.
Data migration
Controlled migration of legacy case and product data with mapping, reconciliation and full verification evidence.
Managed support
Post go-live administration, upgrades, change control and periodic review to keep systems in a validated state.
How we work
A delivery method built around inspection readiness.
Every engagement follows a documented, repeatable lifecycle. Validation is not a phase at the end — it is built into each step, so there are no surprises when auditors arrive.
Step 01
Assess
Current-state review, user requirements, risk assessment and a clear implementation roadmap.
Step 02
Design
Functional and configuration specifications, integration architecture and data migration strategy.
Step 03
Build & validate
Configuration, interface development and test execution with full requirements traceability.
Step 04
Go live & sustain
Controlled cutover, hypercare, user training and ongoing support under change control.
Why DrugSafetySoft
Domain expertise and engineering discipline, in one team.
- Pharma-first focus. We work exclusively in life sciences, so we understand the regulations behind every requirement.
- Vendor-neutral advice. We recommend the platforms and architecture that fit your organization — not a reseller quota.
- Documentation you can defend. Deliverables are written to withstand FDA and EMA inspection.
- Local, accountable team. Based in North Carolina, close to the Research Triangle life sciences community.
“In a regulated industry, a system that works is not enough. It has to be proven to work — and stay that way.”
Planning an implementation or upgrade?
Tell us about your systems and timelines. We will respond within one business day with next steps.
Email our team →
contact@drugsafetysoft.com