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- AID001_AI_Policy_SOP_v2In reviewDOCX · v2.0
Artificial Intelligence Policy
Procedure for identifying, assessing, qualifying, deploying, operating, monitoring, changing, reviewing and retiring AI/ML/GenAI systems in GxP-regulated and general business environments, aligned to GMP, data integrity and data privacy requirements.
Owner · Head of AID – Quality & Compliance Updated 2026-07-31 - AID002_FRM_Access_and_Software_PolicyDraftDOCX · v0.1
Access & Software Policy
Cross-cutting policy for user access control, software approval, licensing and security — applies to all systems at all times.
Owner · Head of AID – Tech / IT Security Updated 2026-07-31 - AID002_FRM_Project_Documentation_Master_FrameworkDraftDOCX · v0.1
AI, Data Engineering & Software Development Documentation Framework
Master framework: risk-based documentation approach, GxP/non-GxP classification, document hierarchy, traceability and governance roles.
Owner · Heads of AID — Business and Technology Updated 2026-07-31 - AID002_FRM_User_Requirements_SpecificationsDraftDOCX · v0.1
URS — User Requirement Specification
Captures business need, user requirements and the GxP/non-GxP classification with justification. Triggered by an approved charter or change request.
Owner · Business / Process owner Updated 2026-07-31 - AID002_FRM_Functional_Specification_DocumentDraftDOCX · v0.1
FSD — Functional Specification Document
Translates requirements into system functions and behaviours, including AI functional performance criteria. Triggered by an approved URS.
Owner · Head of AID – Business / Product owner Updated 2026-07-31 - AID002_FRM_High_Level_DesignDraftDOCX · v0.1
HLD — High-Level Design
Plain-language architecture, data flow and design intent for technical and non-technical stakeholders. Triggered by an approved FSD.
Owner · AID Solution architect / Tech lead / Engineering manager Updated 2026-07-31 - AID002_FRM_Technical_Design_DocumentDraftDOCX · v0.1
TDD — Technical Design Document
Engineering-only deep-dive on the same design areas as the HLD: pseudocode, code snippets, configuration, sample data and screens.
Owner · Tech architect / AI-ML lead / Data & software engineers Updated 2026-07-31 - AID002_FRM_Testing_and_Validation_Plan_NonGxPDraftDOCX · v0.1
Testing & Validation Plan (Non-GxP)
Risk-based functional, performance, security and model evaluation testing verifying the system meets the FSD/TDD.
Owner · QA / Test lead Updated 2026-07-31 - AID002_FRM_Testing_and_Validation_Protocol_GxPDraftDOCX · v0.1
Testing & Validation Protocol (GxP)
Formal IQ/OQ/PQ validation aligned to the organisational CSV SOP; PQ includes AI model performance qualification.
Owner · QA / Validation lead Updated 2026-07-31 - AID002_FRM_Implementation_PlanDraftDOCX · v0.1
Implementation Plan
Deployment strategy, cutover, rollback, training and go-live readiness. Triggered by successful testing sign-off.
Owner · AID Project manager / DevOps lead / Delivery manager Updated 2026-07-31 - AID002_FRM_Support_and_Enhancement_PlanDraftDOCX · v0.1
Support & Enhancement Plan
Post-go-live support model, monitoring, change control and enhancement intake. Triggered by go-live.
Owner · AID Program manager / Delivery manager / Support lead Updated 2026-07-31 - AID002_FRM_VAPT_ReportDraftDOCX · v0.1
VAPT Report
Vulnerability assessment and penetration test report: scope, methodology, findings with severity, evidence, remediation plan and re-verification outcome.
Owner · IT Security / AID Technical lead Updated 2026-07-31 - AID002_FRM_GxP_Bug_Deviation_ReportDraftDOCX · v0.2
GxP Bug / Deviation Report
Per-bug GxP deviation record: description, environment, steps to reproduce, severity and GxP impact assessment, root cause, corrective action, retest evidence and QA closure sign-off.
Owner · Support lead / AID Technical lead / QA Updated 2026-07-31 - AID002_SOP_User_Requirements_SpecificationsDraftDOCX · v0.1
SOP — User Requirements Specification usage
How to gather requirements and complete the URS, including the GxP/non-GxP classification decision.
Owner · AID — Business Updated 2026-07-31 - AID002_SOP_Functional_Specification_DocumentDraftDOCX · v0.1
SOP — Functional Specification Document usage
How to translate approved requirements into functional specifications.
Owner · AID — Technology Updated 2026-07-31 - AID002_SOP_High_Level_Design_documentDraftDOCX · v0.1
SOP — High-Level Design usage
How to produce and review a stakeholder-facing high-level design.
Owner · AID — Technology Updated 2026-07-31 - AID002_SOP_Technical_Design_documentDraftDOCX · v0.1
SOP — Technical Design Document usage
How to produce the engineering-level technical design.
Owner · Engineering / Data team Updated 2026-07-31 - AID002_SOP_Testing_and_Validation_NonGxP_detailsDraftDOCX · v0.1
SOP — Non-GxP Testing & Validation
How to plan and execute non-GxP, risk-based testing and validation.
Owner · QA / Test lead Updated 2026-07-31 - AID002_SOP_Testing_and_Validation_GxP_detailsDraftDOCX · v0.1
SOP — GxP Testing & Validation (IQ/OQ/PQ)
How to plan and execute GxP IQ/OQ/PQ validation in line with the CSV SOP.
Owner · QA / Validation lead Updated 2026-07-31 - AID002_SOP_Implementation_detailsDraftDOCX · v0.1
SOP — Implementation & go-live
How to plan and execute deployment, cutover and go-live.
Owner · Project manager / DevOps lead Updated 2026-07-31 - AID002_SOP_Support_and_Enhancement_runbookDraftDOCX · v0.1
SOP — Support & Enhancement runbook
How to run post-go-live support and intake enhancement requests.
Owner · Product owner / Support lead Updated 2026-07-31 - AID002_SOP_Access_and_Software_usageDraftDOCX · v0.1
SOP — Access & Software usage
How to request, grant and review system access and software approvals.
Owner · Head of AID / IT Security Updated 2026-07-31 - AID002_SOP_VAPTDraftDOCX · v0.1
SOP — VAPT
Procedure for planning, executing and closing vulnerability assessment and penetration testing, including scoping, approvals, severity rating, remediation and re-verification.
Owner · IT Security / Head of AID Updated 2026-07-31 - AID002_SOP_Incident_and_Bug_ManagementDraftDOCX · v0.1
SOP — Incident & Bug Management
Procedure for logging, triaging, prioritising, fixing, retesting and closing support incidents and bugs, including severity/priority matrix and escalation path.
Owner · Support lead / AID Delivery manager Updated 2026-07-31 - AID001_Inventory_Register_Attachment_2DraftDOCX · v0.1
Inventory Register (Attachment 2)
Register of systems, models and platforms in scope of the documentation framework.
Owner · AID Governance Updated 2026-07-31 - AID001_CA_Protocol_Annexure_3DraftDOCX · v0.1
Criticality Assessment Protocol (Annexure 3)
Protocol used to assess system criticality and support the GxP classification decision.
Owner · QA Updated 2026-07-31 - AID001_Periodic_Review_Attachment_5DraftDOCX · v0.1
Periodic Review (Attachment 5)
Template for periodic review of systems, documents and standing policies.
Owner · AID Governance Updated 2026-07-31 - AID001_AI_Model_Card_Annexure_6DraftDOCX · v0.1
AI Model Card (Annexure 6)
Model purpose, data provenance, performance metrics, drift monitoring and explainability record.
Owner · ML lead Updated 2026-07-31 - AID001_Retirement_Plan_Attachment_7DraftDOCX · v0.1
Retirement Plan (Attachment 7)
Template for decommissioning systems, data archival and record retention.
Owner · Product owner / Support lead Updated 2026-07-31 - AID002_FRM_Support_Ticket_and_Bug_RegisterDraftXLSX · v0.1
Support Ticket & Bug Register
Running register of support tickets and bugs with ID, raised date, severity/priority, owner, status, fix release and closure date.
Owner · Support lead Updated 2026-07-31