Every forge (module), one operating model

Clinical Protocol and Data Privacy & Security (DP&S) Analysis

• AI-assisted clinical and data privacy protocol risk review before ethics or HA submission
• AI-assisted DP&S requirements by country and jurisdiction — generate and save for legal / privacy review
• Amendments with tracked changes and package export
• Development of AI-assisted Mitigation plans and analysis handoff into Review & Approve
• Zero raw retention after analysis — structured results persist

CSIL · Business Requirements → AI-driven URS+TM → VP → IQ/OQ/PQ → Human Execution → VSR

• AI-assisted computerized system lifecycle from requirements through qualification
• AI-assisted vendor package review and executable gap protocol
• Smart and fast Configuration Specifications development from screenshots and evidence
• AI-assisted ERES Assessment, System and Audit Trail Periodic Reviews, AI Assurance (validation of AI systems), ISPE Data Integrity evaluation, and Event Log Review

Method validation & OOS

• Analytical method validation packages and catalogs
• Execution worklists with OOS investigation support

Design controls · DHF / DMR / DHR

• 21 CFR 820.30 / ISO 13485 design projects
• ISO 14971 risk linkage and premarket package readiness

Commitments & HA correspondence

• Health authority commitments and due actions
• Correspondence logs and submission readiness — register, not a primary analysis path

GVP readiness · PV audits

• Pharmacovigilance quality intelligence — not a global safety DB
• PSMF / SOP analysis with AuditForge handoff

Launch readiness · stage-gates · PMC

• AI-assisted launch-pack gap review (labeling, artwork, training, supply, market access)
• Cross-functional launch readiness matrix with HITL stage-gates
• Post-marketing commitments linked to RegulatoryForge — not a second RIM
• Launch readiness process — not CRM, MLR system of record, or ERP

EBR & assay gap review

• AI-assisted review of executed batch records — not LIMS or release
• Scientific Formulas: version-bound calculations where enabled

GxP infrastructure

• Component registry, diagrams, and IQ qualification
• Classification and periodic infra qualification status

Automation config / CSIL registry

• DCS / automation hierarchy mapped to the same CSIL systems
• Config change visibility for validated production systems

OT zones & inventory

• Zoning, conduits, remote access, and plant protocol inventory
• Governance forge — diagram import lives under InfraForge

Cyber assessments

• Control-catalog assessments and vendor questionnaires
• Gap packages for GxP-connected environments

AI risk & compliance

• AI system inventory against NIST AI RMF, EU AI Act, and more
• Obligation mapping for GxP / regulated use cases

IT tickets & SLAs

• GxP-aware service tickets with audit trail
• SLA reporting for validated environments

Software asset management

• GxP license inventory, renewals, and unclassified risk

SOC 2 readiness & control program

• Living TSC register with evidence from Change, Tickets, Training, CSIL
• Type I / Type II campaigns per client workspace — not a CPA opinion

Business Continuity Plans

• Guided BIA (RTO/RPO) and category assessment
• Approve-locked packages with DOCX export — human-reviewed drafts only

Structured audits · Plan → Q · AI fieldwork

• Agenda seeds the Plan; questionnaire generated from Plan topics
• Package review (SoD) before Collect; human dispositions in the field

GDPR · HIPAA · CCPA · regional packs

• AI-assisted privacy-pack gap review (policies, DPAs/BAAs, training, breach SOPs)
• Regulation packs chosen at create (GDPR, HIPAA, CCPA/CPRA, UK GDPR, LGPD, and more) copied onto the assessment
• Coverage matrix with HITL: Met needs an evidence pointer; Waived and N/A need a written justification or they stay open
• HITL convert to Change, Quality, Training, Cyber, or AIForge — not a RoPA
• Privacy readiness evaluation — not a privacy management platform or legal advice

Enterprise GxP data governance · ALCOA+ · DIRA

• AI-assisted governance-pack gap review (policy, DIRA (data integrity risk assessment), ATR (audit-trail review) SOP, quality agreement, GDocP (good documentation practice))
• Enterprise D1–D10 maturity heat map across GMP, GCP, GVP, GDP — not CSV (computerized system validation) of one system
• Gap register mapped to ALCOA+ with HITL convert to Change, Quality, Training, or Risk
• Pointers into ValidationForge DIMM (data-integrity maturity), PrivacyForge, and AuditForge vendors — not a second system of record
• Enterprise data-governance assessment — not a certification or legal opinion

Inspection readiness packages

• War-room style readiness before HA visits
• Evidence maps and live request logs

Deviations, CAPA, risk

• Deviation → investigation → CAPA → effectiveness
• Cross-links to Change Control for system / GxP changes

CCR, impact & OQ

• CIA, plan & protocol, OQ execution
• Vendor release notes → structured impact; original notes discarded after impact review

Templates & forms

• QMS packages, SOP/form library, executed forms
• Forge operating manuals for QA review

Curricula & readiness

• Assignments, role matrices, overdue tracking
• Optional gating (e.g. ARF) where training is configured

Early-warning regulatory intelligence

• FDA 483s / Warning Letters and adjacent packs, scored to your inventory
• Accept / Dismiss into Change, CAPA, Training, Ticket, or Audit — human review only

Cross-forge review queue

• One inbox for official analyses, packages, and dispositions
• Nothing becomes the system of record until a person signs it through