Frequently asked questions

BioWise is a compliance orchestration platform for pharmaceutical quality teams. It connects to your existing quality systems — Veeva, SAP, TrackWise, and others — and builds a unified data layer across them. The result is that questions which previously required pulling data from multiple systems manually can be answered in seconds. BioWise doesn't replace any of those systems. It sits alongside them as a read and orchestration layer.

No. BioWise is not a replacement for any existing system. Your teams continue using Veeva, SAP, and TrackWise exactly as they do today. BioWise connects to those systems and makes the data work together — surfacing cross-system answers, tracking relationships between objects (certificates, suppliers, products, components), and automating workflows that currently require manual coordination across multiple systems. Think of it as the layer above your existing systems, not a replacement for any of them.

BioWise has pre-built connectors for 12 systems including Veeva Vault, SAP QM, TrackWise, Loftware/NiceLabel, DocuSign, ServiceNow, SharePoint, EMA, FDA, and WHO. Connectors use read-only API access by default during initial deployment — BioWise reads data from your systems but does not write back unless you explicitly configure write workflows. For systems without a pre-built connector, BioWise supports custom connectors via a REST API and webhook interface.

BioWise reads data from connected systems and stores a normalized representation in its own data layer. Your source systems are not modified. The data BioWise stores is used to build the cross-system object graph — the relationships between suppliers, certificates, components, and products. You control what data is synced and how long it is retained. For on-premises deployments, no data leaves your network.

Yes. BioWise can be used as a standalone platform without connecting to any external system. You can manually upload certificates, create supplier records, define product-component relationships, and run AI agents on data entered directly into BioWise. This is a common starting point for organizations that want to evaluate the platform before configuring integrations. The full AI and compliance functionality is available regardless of whether external systems are connected.

Yes. 21 CFR Part 11 compliance is built into the platform, not added as a feature. This covers electronic records (complete audit trails with before/after values for every data modification, tamper-evident storage, system access controls) and electronic signatures (cryptographic hashing, user identity binding, reason for signature, timestamp). The audit engine and signature engine are Cython-compiled modules — they cannot be modified at runtime, which protects the integrity of compliance-critical functionality.

CSV timelines depend on how BioWise is deployed and what it's used for. For a read-only integration layer — the most common initial deployment — CSV typically takes 4-8 weeks rather than the 3-6 months standard for net-new GxP systems. This is because BioWise ships a pre-built IQ/OQ/PQ validation package (see below), and read-only systems carry lower validation risk under GAMP 5. Full write-back integrations require a longer validation period. We work with your quality and IT validation teams directly.

Yes. BioWise ships a complete Computer System Validation package: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation with 46 documented test cases, all executed and passing. The package follows GAMP 5 risk-based methodology and is structured to integrate with your organization's existing validation SOPs. It is available as part of the Enterprise tier and on request for Professional customers.

Every data modification in BioWise is recorded in an immutable audit log that captures: the action performed, the user who performed it (with authenticated identity), the timestamp, the before and after values of modified fields, and the reason for change where applicable. This applies to both human actions and AI agent actions. Audit logs are tamper-evident, stored separately from application data, and available for export for FDA/EMA inspection. AI agent decisions are logged with full traceability including the input, the decision, the confidence level, and whether human review was involved.

Yes. BioWise supports on-premises and private cloud deployment for organizations that cannot use SaaS infrastructure for GxP data. The full platform — including all AI agents — runs on-premises. AI uses Ollama for local model inference, so no data is sent to external AI providers. On-premises deployment requires Kubernetes and is documented in the infrastructure package. This option is available for Enterprise tier customers.

BioWise is priced on a per-seat, annual subscription basis. There are three tiers: Starter (small quality teams, core certificate and supplier management), Professional (growing organizations, full AI agents, advanced analytics, priority support), and Enterprise (large organizations, unlimited users, dedicated success manager, on-premises deployment option, custom integrations, SLA guarantees). Pricing for Starter and Professional is published on the pricing page. Enterprise pricing is custom and based on scope.

We offer a structured pilot program rather than a self-service free trial. This is intentional — BioWise is a GxP platform and getting meaningful value requires connecting to real systems or loading real data, which is better done with guidance than through a generic trial. A typical pilot is 4-8 weeks and includes implementation support, training, and a defined success criteria document. Request access to start a pilot conversation.

All tiers include email support and access to documentation. Professional adds priority support with a defined response SLA. Enterprise includes a dedicated Customer Success Manager, access to the implementation team for integration setup, on-site training options, and a 24-hour response SLA for critical issues. Support for compliance and validation questions — including help answering your internal CSV or IT security questionnaires — is available across all tiers.

Request a demo via the form on this site. We'll schedule an initial call to understand your systems, use cases, and compliance requirements. From there we'll put together a pilot scope document defining what systems we'll connect to, what success looks like, and what the timeline is. Most pilots start within 2-3 weeks of the initial conversation. We do not require a contract or purchase order to begin a pilot.

Enterprise includes everything in Professional plus: unlimited user seats, on-premises and private cloud deployment, dedicated Customer Success Manager, custom system connectors beyond the 12 standard pre-built connectors, custom AI agent development for organization-specific workflows, SSO/SAML integration, the full IQ/OQ/PQ validation package with implementation support, SOC 2 Type II report on request (once available, target Q2 2026), and negotiated SLA terms. Enterprise pricing is scoped per engagement.