2.1 “Software” means the V5 Traceability software, including updates, upgrades, and documentation provided by Provider under this MSA. This Agreement applies to Version 5.9 during the applicable term unless otherwise agreed in writing.
2.2 “Hosted Services” means the hosting, maintenance, and support of the Software on a third-party cloud hosting provider’s infrastructure, managed by Provider and accessible by Customer via the internet.
2.3 “On-Premise Installation” means the installation and operation of the Software on Customer’s own hardware and / or infrastructure at Customer’s designated location.
2.3.1 “Default Deployment Architecture” means unless otherwise specified in the Order Form / Signed Proposal, the Software shall be deployed on-premises at Customer’s designated location. If Customer elects a hosted (cloud) deployment, this must be clearly indicated on the Order Form / Signed Proposal at the time of order placement.
2.4 “Services” means Hosted Services (if elected), implementation/onboarding services (if purchased), support, maintenance, training assistance, validation assistance, and/or installation services provided by Provider.
2.5 “Order Form / Signed Proposal” means a document, proposal, quote, or other record provided by Provider and accepted by Customer specifying the Software level, deployment election (Hosted vs On-Premise), license type, Services, onboarding/implementation items (if any), fees, and other details of Customer’s engagement.
2.6 “Onboarding / Implementation Services” means one-time professional services purchased by Customer for initial setup, configuration, project management, ERP gap analysis, custom API integration, training sessions, UAT facilitation (if included), validation support (if included), and related rollout activities, as described in the applicable Order Form / Signed Proposal.
2.7 “Onboarding Fees” means one-time fees for Onboarding / Implementation Services, billed upfront as stated in the applicable Order Form / Signed Proposal.
2.8 “ERP Gap Analysis” means a structured analysis of Customer’s ERP data model, workflows, and integration requirements to identify gaps, required mappings, and integration approach, which may be purchased in advance of implementation.
2.9 “Custom API Integration” means API integration work that is specific to Customer’s environment and requirements, including any custom mappings, transforms, or connectors beyond standard configuration, when purchased.
2.10 “Critical Issues” means severe Software malfunctions that prevent Customer from performing essential business operations reliant on the Software.
2.11 “Security Incident” means any unauthorized access, use, disclosure, alteration, or destruction of Customer Data, or a confirmed compromise of the confidentiality, integrity, or availability of Hosted Services.
2.12 “Sandbox Environment” means a separate, isolated testing environment provided by Provider for deploying Software upgrades prior to production use (or, for On-Premise Installations, an environment designated by Customer for testing).
2.13 “Customer Data” means all data uploaded to or generated by the Software by or on behalf of Customer (including regulated records), excluding Usage Data as defined in §2.19.
2.14 “Service Level Agreement (SLA)” means the performance guarantees and commitments outlined in Section 11 of this Agreement, including uptime, response times, and resolution targets for Hosted Services.
2.15 “Renewal Term” means each additional one-year period automatically commenced under Section 5.2.
2.16 “Invoice” means Provider’s written request for payment issued under Section 5.5 and/or Section 6.
2.17 “Device” means a dedicated human–machine interface (HMI) such as a PC or tablet computer used to access the Software, identified by a unique network interface (e.g., MAC address). For clarity, a “Device” does not include passive peripherals such as scales, scanners, printers, or similar equipment—even if such peripherals have IP or MAC addresses—unless expressly listed as licensed HMIs on an Order Form / Signed Proposal.
2.18 “Device License” means a license assigned to a specific Device (HMI) identified by its MAC address or other unique hardware identifier. A Device License is tied to that Device and may not be used concurrently by other devices.
2.19 “Usage Data” means event-level data and metadata generated by Customer’s and Users’ interaction with the Software or Hosted Services, such as login timestamps, user/account identifiers, device or browser type, session duration, feature interactions, performance metrics, and application/error logs. “Usage Data” excludes the business content of Customer’s regulated records except to the extent incidentally captured in error logs.
2.20 “Aggregated/De-identified Data” means data that does not identify—and cannot reasonably be used to identify—any natural person or Customer.
2.21 “User” means an individual authorized by Customer to access the Software.
2.22 “User License” means a license assigned to one named User and may not be shared or rotated among multiple individuals.
2.23 “Documentation” means Provider’s then-current user guides, admin guides, release notes, and training materials made available to Customer.
2.24 “Confidential Information” means non-public information disclosed by a Party that is designated as confidential or that a reasonable person would understand to be confidential, including business, technical, pricing, security, product information, and Customer Data.
2.25 “DPA” means Provider’s Data Processing Addendum (if applicable), incorporated by reference where required by law and made available upon request.
2.26 “Assessment Documentation” means the independent assessment documentation made available by Provider regarding the Software’s alignment with technical controls commonly associated with 21 CFR Part 11, EU Annex 11, and GMP expectations (e.g., assessment report and supporting artifacts provided by Provider, if any).
2.27 “IQ/OQ” means installation qualification and operational qualification activities performed as part of Customer’s validation program in Customer’s environment.
2.28 “UAT” or “User Acceptance Testing” means the pre-go-live testing performed to confirm configured workflows and system behavior meet Customer’s intended use and acceptance criteria.