Frequently Asked Questions

BioWise is an intelligent compliance orchestration platform designed for pharmaceutical and life sciences companies. It connects your existing quality systems (like Veeva, SAP, and TrackWise) into a unified layer, enabling cross-system visibility, automated workflows, and AI-powered document processing without replacing your current systems.

BioWise uses pre-built connectors and APIs to integrate with common pharmaceutical quality systems including Veeva Vault, SAP QM, TrackWise, LIMS, and document management systems. We sit alongside your existing infrastructure as an orchestration layer, reading and correlating data without requiring you to migrate or replace your current systems.

BioWise can process a wide variety of quality documents including Certificates of Analysis (CoA), Certificates of Conformity (CoC), supplier qualification documents, audit reports, deviation reports, CAPA documentation, batch records, and regulatory submissions. Our AI agents extract structured data from both digital and scanned documents.

No. BioWise is designed to complement and connect your existing systems, not replace them. We understand that pharmaceutical companies have significant investments in validated systems like Veeva and SAP. BioWise serves as an intelligent layer that makes these systems work together more effectively.

Yes. BioWise is designed from the ground up to meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. This includes complete audit trails, user authentication, access controls, data integrity safeguards, and electronic signature capabilities with signer identification.

BioWise aligns with EU GMP Annex 11 guidelines for computerized systems in GMP-regulated environments. We provide risk-based validation support, supplier qualification documentation, periodic review capabilities, change control mechanisms, and business continuity features as required by the regulation.

BioWise is classified as a GAMP Category 4 (Configured Product) system. This means validation focuses on configuration verification rather than full code-level testing, significantly reducing your validation burden while maintaining compliance. We provide comprehensive validation documentation including URS, FS, and IQ/OQ/PQ protocols.

Every feature in BioWise is designed with ALCOA+ principles at its core. Data is Attributable (every action linked to a user), Legible (clear, permanent records), Contemporaneous (recorded at time of event), Original (first capture preserved), and Accurate. We also ensure data is Complete, Consistent, Enduring, and Available throughout its lifecycle.

Absolutely. We provide comprehensive Computer System Validation (CSV) support packages including User Requirements Specifications, Functional Specifications, Design Specifications, and IQ/OQ/PQ protocols. Our team works with your quality assurance department to ensure a smooth validation process aligned with your SOPs.

BioWise employs enterprise-grade security including AES-256 encryption at rest, TLS 1.3 encryption in transit, multi-factor authentication, role-based access control (RBAC), and complete multi-tenant data isolation. We also offer customer-managed encryption keys for organizations requiring additional control.

BioWise is hosted on AWS infrastructure with data residency options in the United States and European Union. We maintain SOC 2 Type II certification and ISO 27001 compliance. For organizations with specific data sovereignty requirements, we offer dedicated deployment options.

Yes. BioWise supports enterprise SSO integration via SAML 2.0 and OpenID Connect (OIDC) protocols. This allows your users to authenticate using your existing identity provider (such as Azure AD, Okta, or Ping Identity) while maintaining centralized access control.

BioWise implements Zero Trust security principles for supplier access. Suppliers can only access data specifically shared with them through our secure portal. All access is authenticated, authorized per-resource, and fully audited. This eliminates the security risks associated with VPN-based supplier access.

BioWise AI agents are specialized assistants that automate specific quality workflows. Our Certificate Intake Agent extracts data from supplier documents. The Change Impact Agent assesses how changes affect related products and processes. The Expiry Management Agent monitors certificate and qualification expiries. All AI actions are logged with complete audit trails and include human-in-the-loop review capabilities.

Yes. All AI agent actions in BioWise are fully transparent and auditable. Every AI decision includes an explanation of the reasoning, confidence scores, and source references. Critical decisions require human approval before execution. Complete audit trails capture what the AI analyzed, concluded, and recommended.

Yes. BioWise AI agents can be configured to match your organization's specific workflows, terminology, and decision criteria. This includes customizing extraction rules for your supplier document formats, setting thresholds for automated versus human-reviewed decisions, and defining approval workflows.

Implementation timelines vary based on scope and complexity. A typical pilot deployment connecting 2-3 systems takes 4-8 weeks. Full enterprise deployments with multiple system integrations and custom workflows typically take 3-6 months. We follow an agile implementation methodology with early wins and iterative expansion.

Our implementation includes a dedicated project manager, technical integration specialists, and validation consultants. We provide hands-on training for your team, comprehensive documentation, and knowledge transfer sessions. Post-implementation, you have access to our support team and customer success managers.

BioWise provides tiered support options including standard business hours support, extended hours support, and 24/7 premium support. All plans include access to our knowledge base, regular system updates, security patches, and quarterly business reviews to optimize your use of the platform.

BioWise pricing is based on a subscription model that considers the number of connected systems, data volume, and feature modules required. We offer packages for mid-size companies and enterprise deployments. Contact our sales team for a customized quote based on your specific requirements.

We offer a proof-of-concept engagement where we work with your team to demonstrate BioWise capabilities using your actual data and systems. This allows you to validate the value proposition before committing to a full deployment. Contact us to discuss a POC for your organization.