Quality Manual

Purpose. This Quality Manual defines the quality management framework used by SG Systems Global for the delivery, support, maintenance, and governance of V5 Traceability and related services.

Scope. This manual applies to software and service activities delivered by SG Systems Global, including Hosted Services and On-Premise Installations where elected in an applicable Order Form or Signed Proposal.

Use. This manual is intended to support supplier qualification, governance review, audit preparation, and regulated-use discussions.

Document hierarchy. If there is a conflict, the controlling documents are:

• (1) Order Form / Signed Proposal for scope, deployment model, tier selections, and effective dates;
• (2) Supplier Quality Addendum (SQA) for regulated or GxP operating constructs, where incorporated; and
• (3) Master Services Agreement (MSA) for the broader legal, commercial, SLA, security, and customer-data framework.

Contract alignment. This manual describes the SG Systems Global quality framework. It does not amend contractual obligations.

Quality contact: support@sgsystemsglobal.com

SG Systems Global maintains a risk-based quality management framework intended to support reliable software delivery, governed service execution, supplier qualification, and controlled support for customers operating in regulated environments.

Core elements include:

• Governance and accountability for corporate, technical, compliance, support, and delivery decisions;
• Controlled documentation and traceable supporting records;
• Change and release governance for updates affecting service delivery or regulated use;
• Issue and corrective action handling where quality, service, or compliance concerns arise;
• Supplier oversight within the service boundary; and
• Continuous improvement through review, learning, and controlled revision.

SG Systems Global assigns accountable ownership for executive governance, platform governance, release control, support escalation, implementation oversight, and supplier-quality coordination.

• Corporate governance: oversight of contracts, supplier commitments, and enterprise escalation;
• Technical governance: platform authority, lifecycle control, and release oversight;
• Delivery governance: onboarding ownership, deployment coordination, and post-go-live support structure; and
• Regulated-use support: coordination of supplier-quality materials and audit-facing responses where required.

References: Leadership & Governance, Onboarding & Implementation.

SG Systems Global maintains controlled documents and records appropriate to its operating model. Governance pages, contractual documents, and qualification materials are maintained as controlled references where applicable.

Document control principles include:

• Version control: current materials are maintained and superseded content is not presented as active guidance;
• Review and approval: trust, security, and contractual materials are reviewed before publication;
• Supporting records: delivery, support, release, and issue records are maintained to support traceability and review; and
• Reference alignment: published summaries align to the controlling agreement set.

SG Systems Global assigns responsibilities by role and expects personnel to be competent for the work they perform. Role-based onboarding, technical enablement, and support readiness are part of maintaining a controlled operating model.

• Role clarity: responsibilities are aligned to governance, support, implementation, technical delivery, and quality obligations;
• Competence: personnel are expected to be appropriately prepared for the work assigned;
• Training support: customers receive onboarding and training support as purchased and governed under the applicable agreement set; and
• Customer responsibility: customers remain responsible for ensuring their own users are trained under their SOPs and regulatory obligations.

References: MSA, Onboarding & Implementation, Independent 21 CFR Part 11 Assessment.

SG Systems Global maintains controlled lifecycle and release practices intended to support a reliable and auditable software posture for customers operating in production and regulated environments.

Lifecycle and release control includes:

• Controlled change introduction: changes are planned, implemented, reviewed, and released through governed processes;
• Impact awareness: customer impact and regulated-use implications are considered where relevant;
• Release documentation: release notes and related summaries identify material changes and, where applicable, validation considerations; and
• Deployment boundary: Hosted Services deployments are provider-controlled, while On-Premise deployments are customer-controlled unless otherwise agreed.

References: Security & Trust, SQA, MSA.

SG Systems Global maintains issue handling and escalation practices intended to support prompt triage, investigation, communication, and completion tracking where quality, service, or regulated-use concerns arise.

• Classification: events are assessed by severity, impact, and urgency;
• Escalation: higher-severity or regulated-impact issues are routed through defined escalation paths;
• Investigation: material issues are reviewed to identify cause, containment, and corrective action needs; and
• Corrective action: actions are assigned and tracked to reduce recurrence risk where appropriate.

References: Security & Trust, SQA.

SG Systems Global uses third-party providers where appropriate to support service delivery. Oversight is applied in a manner consistent with the selected deployment model, confidentiality obligations, and agreed service commitments.

• Selection and suitability: providers are chosen based on business, technical, and service relevance;
• Contractual control: provider relationships are governed by written terms aligned to confidentiality and service expectations;
• Boundary awareness: Hosted and On-Premise responsibilities remain clearly separated; and
• Accountability: SG Systems remains responsible for the commitments it makes within the agreed scope.

References: Security & Trust, MSA.

SG Systems Global controls delivery through defined onboarding stages, implementation ownership, support pathways, and escalation routes designed to support stable go-live and steady-state operations.

• Onboarding structure: scope, delivery path, and responsibilities are defined through the commercial and onboarding process;
• Support handling: operational questions, issues, and escalations are routed through the support model defined in the contract framework;
• Post-go-live continuity: ongoing support follows the subscription support scope and SLA terms where applicable; and
• Expansion control: material scope changes, integrations, or redesigns are handled through controlled commercial and delivery processes.

References: Onboarding & Implementation, MSA, FAQ.

SG Systems Global supports due diligence and supplier qualification by providing governance materials, contractual quality-operational constructs for regulated accounts, and assessment artifacts intended to support review by QA, CSV, and procurement teams.

• Supplier qualification support: structured responses and reference materials are provided appropriate to the service boundary;
• Quality-operational framework: the SQA defines regulated-use expectations where incorporated into the engagement;
• Independent assessment support: the Part 11 assessment is positioned as an assessor-authored supplier artifact, not a blanket certification; and
• Validation boundary: intended use, validation, SOPs, and site controls remain customer responsibilities.

References: SQA | Independent 21 CFR Part 11 Assessment | Security & Trust

SG Systems Global uses periodic review and management oversight to evaluate whether its governance framework, delivery controls, and supplier-facing materials remain suitable for the current operating model.

Review inputs may include:

• Delivery and support trends
• Issue and escalation learnings
• Change and release observations
• Customer qualification requests and audit expectations
• Updates required to trust, contract, or governance materials

SG Systems Global supports due diligence and reasonable audit-related dialogue subject to confidentiality, scope, and the applicable agreement set.

• Qualification dialogue: structured responses can be provided to support supplier review;
• Audit cooperation: support is provided subject to reasonable scheduling and confidentiality obligations;
• Quality communication: material issues, support requests, and supplier-facing questions can be routed through defined contact channels; and
• Inspection support: regulated customers may request supplier-side information support where provider-controlled components are relevant.

Contact: support@sgsystemsglobal.com

Certain supplier-qualification questions may not apply to SG Systems Global in the same way they would apply to a physical manufacturer, testing laboratory, warehouse operator, or product release authority.

• Physical testing equipment questions: may be not applicable unless tied to a specific scoped service;
• Calibration or lab-method questions: may not apply to the core software and services model;
• Batch release or production-disposition questions: remain customer-side responsibilities unless expressly agreed; and
• Site-specific quality controls: are answered based on the actual service scope and deployment boundary.

Additional documentation may be provided to support supplier qualification, quality review, and regulated procurement workflows, subject to confidentiality obligations and, where applicable, NDA controls.

Examples may include:

• Structured supplier-questionnaire responses
• Quality or governance clarification letters
• Change-management and release summaries
• Incident or continuity summaries aligned to the selected deployment boundary
• Independent assessment materials, where applicable
• Supporting privacy, hosting, or subprocessor information where applicable

This manual does not modify contractual terms.