SOP Alignment
Implemented
GMP FlowReceiving is shown as Receive, Inspect, Quarantine, external QA/QC disposition reference, then Inventory Available when Released.
Audit evidence for receiving and inventory records.
Audit evidence for receiving records, stock state, traceability, and known future controls.
Retained paper controls, Depot-native replacements, derived registers, role boundaries, and report readiness.
Receipt, inspection, exception, quarantine, external QC/QA reference, authorized disposition, and inventory consequence chain evidence.
Adversarial consistency review covering state leakage, quantity conservation, and shared availability logic.
Future controls required before production validation and controlled operational use.
| Step | State Boundary | Depot Evidence | Availability Effect | Status |
|---|---|---|---|---|
| Receive | Received | MRN reference, Receiving Transaction, supplier, delivery note, material, quantity, carrier, receiver, package count. | Physical evidence exists; inventory is not usable. | Controlled Entry |
| Inspect | Awaiting Inspection / Under Inspection | Native inspection checks for packaging, label, quantity, documents, COA, damage, visual condition, comments, and photographs. | Inspection evidence is captured; inventory remains unavailable. | Native Record |
| Quarantine | Quarantined | Quarantine inventory row, location, availability blocker, segregation evidence, and custody movement records. | Physical stock may exist, but cannot support issue, readiness, coverage, or reorder usable stock. | Not Available |
| Review | QC Review / Technical Review | External evidence requirement flag, external source reference, external result reference, QC recommendation, COA, and external report attachments. | Review may support an external QA/QC decision; it does not change inventory availability by itself. | Review Evidence |
| QA Disposition | Released / Rejected / Hold | Authorized disposition reference, authorized role, decision date, previous state, new state, comments, and resulting location. | Only Released disposition state can create usable inventory. | Inventory Boundary |
| Inventory Available | Released / Available | Inventory creation record and released available stock position. | Stock can support issue, readiness, coverage, reorder usable stock, and valuation views. | Usable |
| Control | Why Retained | Depot Support | Evidence Use | Status |
|---|---|---|---|---|
| Material Received Note | Physical goods handover, driver and receiver signatures, carbon-copy distribution, loading bay usability, outage resilience, and chain-of-custody evidence. | MRN number, MRN date, supplier, delivery note, receiver, package count, and optional scan/photo attachment. | Controlled source document for physical receipt before Depot receiving transaction capture. | Retained |
| Stock Movement Advice | Physical movement authorization, receiver/security/QA signatures, loading-area usability, outage resilience, and independent custody evidence. | SMA number, source, destination, material, quantity, reason, requestor, receiver, security verification, QA verification, and optional attachment. | Controlled source document for physical custody movements without changing QA state. | Retained |
| Paper Record | Depot Replacement | Source Records | Report Output | Status |
|---|---|---|---|---|
| Receiving Register | Receiving Transaction records and Receiving Register report. | RCV, MRN, supplier, delivery note, material, quantity, state, location, status history. | Receiving Register | Depot Native |
| Receiving Inspection Report | Native Receiving Inspection workflow and inspection history. | INS records, inspection checks, comments, photographs, inspector, timestamp, decision. | Inspection Register | Depot Native |
| Register | Source Data | Control Purpose | Responsible Role | Evidence Retained | Status |
|---|---|---|---|---|---|
| Receiving Register | RCV and MRN-linked transaction records. | Show what arrived, who received it, and where it sits in the receiving state model. | Receiving | MRN reference, supplier, delivery note, material, quantity, status, current location. | Implemented |
| Inspection Register | INS inspection records. | Show who inspected material and what inspection decision was recorded. | Receiving | Packaging, label, quantity, documentation, COA, damage, visual checks, comments, photos. | Implemented |
| Quarantine Inventory Report | QTN/REJ records and availability bucket rows. | Separate physical stock from released available stock and final dispositions. | Warehouse / QA | Location, availability blocker, segregation evidence, returned/disposed accounting. | Implemented |
| QA Disposition Register | QAR records. | Show authorized disposition outcomes with reference, authorized role, decision date, previous state, new state, and inventory consequence. | QA/QC reference owner | Disposition reference, authorized role, decision date, previous state, new state, comments, and resulting location. | Implemented |
| Rejected Material Register | QA rejection decisions and rejected disposition records. | Keep rejected material non-issuable and traceable even after return or disposal. | QA / Warehouse | Inspection evidence, rejection reason, segregation, return or disposal outcome. | Implemented |
| Receiving Exception Register | EXC exception records. | Show what was expected, what arrived, what was wrong, what was accepted, what was rejected, and what happened next. | Receiving / QA | Exception category, expected/received/variance quantities, disposition, rationale, evidence. | Implemented |
| Hold Inventory Register | Hold state records and hold-related exceptions. | Show material blocked pending documentation, external source evidence, or authorized disposition. | QA | Hold reason, availability blocker, current location, next control. | Implemented |
| Missing Documentation Register | Missing COA, missing documentation, and supplier documentation mismatch exceptions. | Show documentation blockers that prevent Released disposition. | Receiving / QA | Missing evidence class, affected material, next control, availability blocker. | Implemented |
| Supplier Return Register | RTS return disposition records. | Show returned quantity, destination supplier, reason, authorized disposition reference, and permanent receipt history. | Warehouse / QA | Return date, quantity, supplier destination, QA evidence, SMA evidence. | Implemented |
| Disposed Material Register | DIS disposal records. | Show disposed quantity, reason, authorized disposition reference, and permanent traceability. | QA / Warehouse | Disposal date, quantity, reason, authorized disposition reference, historical visibility. | Implemented |
| SMA Register | SMA movement authorization records. | Show paper-only, digital-only, or hybrid movement authorization evidence without changing QA state. | Warehouse / Security / QA | SMA number, source, destination, material, quantity, reason, requestor, receiver, security, QA verification. | Implemented |
| Inventory Architecture Consistency Review | Shared availability helper, receiving availability rows, lots, reports, readiness, command search, and traceability evidence. | Show adversarial consistency review for state leakage, quantity conservation, and single-source availability logic. | Validation Reviewer | Verified controls, resolved inconsistencies, consolidations, and remaining risks. | Implemented |
| Prefix | Purpose | Created By | Controlled State | Evidence Type | Related Report | Status |
|---|---|---|---|---|---|---|
| MRN | Material Received Note source reference. | Receiving personnel on paper; referenced in Depot. | Physical receipt source evidence. | Paper reference, optional scan/photo. | Receiving Register | Source Document |
| RCV | Receiving transaction. | Receiving | Received, Awaiting Inspection, Under Inspection, Quarantined, Released, Rejected. | Supplier, PO, delivery note, MRN, material, quantity, lot, expiry, COA/SDS flags. | Receiving Register | Controlled Record |
| INS | Receiving inspection record. | Receiving inspector. | Accepted, Accepted with Observation, Rejected. | Inspection checks, comments, photographs, inspector, timestamp. | Inspection Register | Controlled Record |
| QTN | Quarantine inventory record. | Warehouse / Receiving. | Quarantine or Hold. | Location, availability blocker, segregation evidence. | Quarantine Inventory Report | Unavailable |
| QCR | QC or technical review record. | QC / Technical reviewer. | Review recommendation. | External evidence requirement, external source reference, external result reference, QC recommendation. | QA Disposition Register | Review Evidence |
| QAR | QA disposition inventory outcome. | Depot records an external authorized QA/QC disposition reference. | Released, Rejected, Hold. | Disposition reference, authorized role, decision date, previous state, new state, comments. | QA Disposition Register | Inventory Consequence |
| EXC | Warehouse receiving exception. | Receiving / QA. | Open, Hold, Awaiting Balance, External Evidence Requested, Closed. | Expected quantity, received quantity, variance, disposition, rationale, evidence. | Receiving Exception Register | Exception Evidence |
| SMA | Stock Movement Authorization. | Warehouse / Requestor with security and QA verification as applicable. | Requested, Authorized, Completed. | SMA number, source, destination, material, quantity, reason, receiver, security, QA evidence. | SMA Register | Movement Evidence |
| RTS | Return to supplier disposition. | Warehouse / QA. | Returned. | Return reason, return date, quantity returned, supplier destination, authorized disposition reference. | Supplier Return Register | Returned |
| DIS | Disposal disposition. | QA / Warehouse. | Disposed. | Disposal reason, quantity disposed, authorized disposition reference, date. | Disposed Material Register | Disposed |
| REJ | Rejected material inventory evidence. | Warehouse / QA. | Rejected, Returned, or Disposed outcome. | Rejected tag, segregation evidence, QA rejection, final disposition. | Rejected Material Register | Rejected Trace |
| INV | Inventory creation or non-creation outcome. | Depot system after authorized disposition evidence. | Usable stock created only after Released disposition; otherwise non-usable traceability record. | Source state, inventory result, released location, availability flag, traceability chain. | Stock Position / QA Disposition Register | Inventory Boundary |
| State | Available for Issue | Counts in Readiness | Counts in Reorder Usable Stock | Custody Transfer | Requires QA Decision | Status |
|---|---|---|---|---|---|---|
| Received | No | No | No | Yes | Yes - must inspect and review first. | Not Usable |
| Awaiting Inspection | No | No | No | Yes | Yes - inspection and review still pending. | Not Usable |
| Under Inspection | No | No | No | Yes | Yes - inspection is not release. | Not Usable |
| Quarantined | No | No | No | Yes | Yes - authorized QA/QC disposition reference required. | Not Usable |
| Hold | No | No | No | Yes | Yes - hold must be resolved by QA. | Blocked |
| Rejected | No | No | No | Yes | Decision recorded; final return/disposal path may follow. | Blocked |
| Returned | No | No | No | No | No - final disposition; not physical on-hand. | Final |
| Disposed | No | No | No | No | No - final disposition; not physical on-hand. | Final |
| Released / Available | Yes | Yes | Yes | Yes | Completed - Released disposition is the availability boundary. | Usable |
| Control Statement | Where Enforced | Evidence Surface | Status |
|---|---|---|---|
| Quarantined stock cannot be issued. | Shared availability helper, Stock Register issue guardrail, movement examples, quarantine reports. | Quarantine Inventory, Stock Register, Movements, Reports. | Verified |
| Hold stock cannot be issued. | Shared availability helper and hold-specific issue block message. | Hold Inventory Register, QA Disposition, Stock Register. | Verified |
| Rejected stock cannot be issued. | Shared availability helper, rejected material report, movement blocked-state evidence. | Rejected Material Register, Receiving Traceability, Movements. | Verified |
| Returned stock is not physical on-hand. | Bucketed availability model excludes returned quantity from physical stock and released availability. | Supplier Return Register, Lots, Receiving Availability, Inventory Architecture Consistency Review. | Verified |
| Disposed stock is not physical on-hand. | Bucketed availability model excludes disposed quantity from physical stock and released availability. | Disposed Material Register, Lots, Receiving Availability, Traceability. | Verified |
| Missing-COA stock cannot become Released. | Receiving exception model and disposition evidence show documentation blocker before any Released outcome. | Missing Documentation Register, Receiving Exception Register, QA Disposition. | Verified |
| Transfers do not change QA state. | SMA movement effect states custody movement only; QA state remains unchanged unless QA records a decision. | SMA Register, Inventory Movements, Quarantine Transfer records. | Verified |
| Partial accept/reject totals must reconcile to receipt quantity. | Receiving availability rows carry physical, returned, disposed, and total accounted buckets. | Lots, Receiving Exception Register, Inventory Architecture Consistency Review. | Verified |
| Readiness and coverage use released stock only. | Shared stock-position and allocation helpers use released available quantity for readiness, coverage, reorder, and commitment surfaces. | Coverage Map, Equipment Survival, Reorder Watch, Allocations, Reports. | Verified |
| Category | Receiving Problem | Control Expectation | Availability Rule | Status |
|---|---|---|---|---|
| Partial Delivery | Expected quantity is not fully received. | Record expected, received, and outstanding balance while preserving the original receipt. | Received quantity remains quarantined until inspection, review, and authorized disposition. | Balance Tracked |
| Over Delivery | Supplier delivers more than ordered or expected. | Record excess quantity and disposition rationale before accepting or returning excess. | Excess remains unavailable unless an authorized Released disposition is recorded for the accepted quantity. | Excess Controlled |
| Under Delivery | Received quantity is below ordered quantity. | Separate supplier shortfall from a receiving count error. | Only physically received quantity with an authorized Released disposition can become available. | Shortfall Controlled |
| Damaged Packaging | Outer packaging, seals, cartons, pallets, or containers are damaged. | Capture severity, photos, inspector comments, and accepted or rejected quantities. | Damaged or observed stock remains unavailable until authorized disposition. | Photo Evidence |
| Damaged Material | Material itself appears compromised or contaminated. | Segregate affected quantity and retain inspection evidence. | Affected material cannot be issued; reject, hold, return, or dispose by controlled disposition. | Segregate |
| Missing COA | Required certificate of analysis is absent. | Record missing COA and hold pending documentation. | Released disposition is blocked until COA evidence is available and reviewed. | Disposition Blocked |
| Missing Documentation | Required delivery, supplier, SDS, or support documents are absent. | Record missing document class and follow up without deleting receipt evidence. | Material stays quarantined or on hold until documentation review is complete. | Documentation Hold |
| Expired Material | Material is received after expiry. | Record expiry date, review comments, and rejection or hold rationale. | Expired material cannot become available through receiving or transfer. | Reject / Hold |
| Near Expiry Material | Material has limited remaining shelf life. | Record expiry date, days remaining, and review comments. | Conditional availability is a placeholder only; authorized disposition evidence is still required. | Review Required |
| Incorrect Material | Received material does not match PO, delivery note, or label expectation. | Hold or reject while retaining supplier and receipt evidence. | Incorrect material cannot become available unless corrected and authorized for Released disposition. | Mismatch |
| Incorrect Lot Number | Expected lot differs from received lot. | Record expected lot, received lot, and documentation correction placeholder. | Lot mismatch remains unavailable until review and authorized disposition. | Lot Hold |
| Incorrect Labeling | Label text, identity, lot, expiry, or handling label is incorrect. | Capture label evidence and hold pending correction or rejection. | Label exceptions cannot bypass authorized disposition. | Label Hold |
| Incorrect Quantity | Physical count differs from expected or documented quantity. | Record count evidence, accepted quantity, and variance. | Only confirmed and released quantity becomes available. | Count Variance |
| Supplier Documentation Mismatch | Supplier documents conflict with label, lot, quantity, or delivery data. | Hold material and keep mismatch evidence linked to the receipt. | Released disposition is blocked until mismatch disposition is documented. | Mismatch Hold |
| Failed Inspection | Native receiving inspection fails packaging, labeling, quantity, document, or visual checks. | Link failed inspection to quarantine, hold, rejection, return, or disposal outcome. | Failed inspection cannot produce available inventory. | Failed |
| Failed QC Review | Technical review does not support Released disposition. | Capture QC recommendation and hold, reject, re-sample, return, or dispose. | Released disposition remains blocked until review is complete. | QC Hold |
| Hold Pending Review | Warehouse needs more evidence before final disposition. | Record reason for hold and preserve status history. | Hold can be removed only by authorized QA/QC disposition; history remains immutable. | Hold |
| Return to Supplier | Material must leave site under controlled return evidence. | Record return reason, date, quantity, and supplier destination. | Return is a final disposition, not usable inventory. | Return |
| Disposal Required | Material must be disposed of instead of released or returned. | Record disposal reason, quantity, authorized disposition reference, date, and traceability. | Disposed material remains historically visible and non-issuable. | Disposal |
| External Review Required | External review requires additional source evidence. | Track source reference requested, source reference received, and awaiting external result states. | Inventory remains unavailable while external source evidence is pending. | External Evidence Pending |
| Disposition | Control Meaning | Availability Effect | Status |
|---|---|---|---|
| Released | Inventory with an authorized Released disposition can become usable stock. | Available for issue, readiness, coverage, reorder usable stock, and operational use. | Released |
| Rejected | Rejected disposition inventory remains non-issuable and segregated. | Unavailable; may move only as controlled custody for return or disposal. | Rejected |
| Returned | Rejected or excess material returned to supplier remains historically visible. | Not physical on-hand and not available. | Returned |
| Disposed | Rejected material disposed with an authorized disposition reference remains historically visible. | Not physical on-hand and not available. | Disposed |
| Held | Material is blocked pending external source-record review or documentation. | Unavailable until an authorized disposition changes state. | Held |
| Role | May | May Not | Evidence Surface | Status |
|---|---|---|---|---|
| Receiving | Receive material, record receipt, record inspection, capture MRN references and evidence. | Record authorized QA/QC disposition references. | Receiving Transactions, Receiving Inspections, SOP Crosswalk. | Visible Boundary |
| QA | Provide or record authorized disposition references for release, hold, rejection, return, or disposal. | Use Depot as the QMS/LIMS/QC approval record. | QA Disposition and QA Disposition Register. | Authorized Elsewhere |
| Operations | View status and use released inventory. | Override QA state or issue unavailable inventory. | Stock Register, Movements, Dashboard, Readiness surfaces. | Released Only |
| Security / Custody | Verify physical movements where SMA applies. | Change QA state. | SMA Register and Stock Movement Authorizations. | Custody Only |
| Scenario | Event Chain | Captured Evidence | Related Records | Status |
|---|---|---|---|---|
| Normal release | Received -> Inspection Complete -> External QC/QA reference -> Released disposition -> Inventory Available. | Previous state, new state, authorized role, decision date, disposition reference, controlled record id, and optional comments. | RCV-2026-000002, INS-2026-000002, QCR-2026-000002, QAR-2026-000001, INV-2026-000001. | Example Chain |
| Missing COA hold | Received -> Inspection Rejected / Documentation Missing -> Exception -> Rejected or Hold disposition. | Missing document category, availability blocker, inspector, disposition reference, and comments. | RCV-2026-000004, INS-2026-000003, EXC-2026-000003, QAR-2026-000003. | Blocked |
| Partial accept/reject | Received -> Inspection Complete -> Exception -> QTN accepted portion / REJ rejected portion -> authorized hold/rejection disposition. | Expected, received, accepted, rejected, disposed, and total accounted quantities. | RCV-2026-000006, INS-2026-000004, EXC-2026-000004, QAR-2026-000004, QAR-2026-000005. | Reconciled |
| Return to supplier | Receiving Transaction -> Exception -> Rejected disposition -> SMA custody movement -> Return to Supplier. | Return reason, return date, quantity returned, destination supplier, disposition reference, and SMA evidence. | RCV-2026-000004, EXC-2026-000003, QAR-2026-000003, SMA-2026-000003, RTS-2026-000001. | Returned |
| Disposal | Receiving Transaction -> Exception -> Rejected disposition -> Disposal Record. | Disposal reason, quantity disposed, disposition reference, date, historical visibility. | RCV-2026-000006, EXC-2026-000004, QAR-2026-000005, DIS-2026-000001. | Disposed |
| Activity | User | Timestamp | Action | Previous State | New State | Comment / Reason |
|---|---|---|---|---|---|---|
| ACT-1010 | Warehouse User | 2026-06-15 12:51 | Issue blocked | Rejected | Rejected | Rejected inventory cannot be issued. |
| ACT-1011 | J. Mokoena | 2026-06-15 14:10 | Receiving exception opened | Received | Awaiting Balance | EXC-2026-000001 records partial delivery: 60 EA expected, 48 EA received, 12 EA outstanding. |
| ACT-1012 | N. Pillay | 2026-06-16 11:28 | Partial accept/reject recorded | Under Inspection | Quarantine / Rejected | EXC-2026-000004 splits one receipt into 80 containers held in quarantine and 20 containers rejected. |
| ACT-1013 | Warehouse Lead | 2026-06-15 14:25 | Quarantine custody movement | Quarantine | Quarantine | QTM-2026-000001 moved stock from dock to Incoming Inspection. Availability unchanged. |
| ACT-1014 | QA Manager A | 2026-06-16 09:20 | Sample requested | Hold | Hold | EXC-2026-000005 keeps Cleaning Sanitizer unavailable while sample result is pending. |
| ACT-1015 | Warehouse Lead | 2026-06-16 14:20 | Supplier return completed | Rejected | Returned | RTS-2026-000001 removed 200 L from physical stock while retaining returned quantity in receiving history. |
| ACT-1016 | QA Manager A | 2026-06-16 14:35 | Disposal completed | Rejected | Disposed | DIS-2026-000001 disposed 20 rejected containers; disposed quantity remains traceable and non-issuable. |
| Scenario | Traceability Path | Final Disposition | Evidence Surface | Status |
|---|---|---|---|---|
| Normal Released Material | Receiving Transaction -> Inspection -> Quarantine -> external QC/QA reference -> QA Disposition -> Available Inventory. | Released | Receiving Traceability and QA Disposition Register. | Released |
| Rejected Material | Receiving Transaction -> Inspection -> Exception -> Rejected disposition -> Rejected Inventory. | Rejected | Rejected Material Register and Receiving Traceability. | Rejected |
| Returned Material | Receiving Transaction -> Exception -> Return to Supplier. | Returned | Supplier Return Register and Receiving Traceability. | Returned |
| Disposed Material | Receiving Transaction -> Exception -> Disposal Record. | Disposed | Disposed Material Register and Receiving Traceability. | Disposed |
| Gap | Risk | Future Control | Status |
|---|---|---|---|
| Real authentication not yet implemented. | User identity and role attribution are demo/static rather than enforced. | Implement authenticated user identity and validated user provisioning. | Future Control Required |
| Persistent database not yet implemented. | Static records cannot prove durable write/read behavior or data retention. | Persist controlled records, states, identifiers, and immutable audit events in validated storage. | Future Control Required |
| File upload/storage not yet implemented. | Attachment sections exist, but evidence files are not yet stored or linked. | Implement controlled file storage, checksum or version metadata, and retention rules. | Future Control Required |
| Audit trail immutability must be technically enforced. | Append-only presentation exists, but persistence-layer immutability is not yet proven. | Enforce append-only audit records, database constraints, and audit trail review reports. | Future Control Required |
| Role permissions must be enforced server-side. | Visible role boundaries do not yet prevent unauthorized server actions. | Implement server-side authorization checks for disposition records, holds, releases, returns, and disposals. | Future Control Required |
| Data retention policy required. | Retention periods for MRN scans, COAs, external result references, inspection photos, and audit records are not defined. | Approve retention schedule and enforce archival/deletion rules. | Future Control Required |
| Backup/restore evidence required. | A production reviewer cannot confirm controlled records can be recovered. | Document backup schedule, restore tests, and recovery evidence. | Future Control Required |
| User access review required. | No periodic review evidence for QA/QC reference recorders, Receiving, Operations, or Security permissions. | Create access review procedure and evidence report. | Future Control Required |
| SOP approval required. | Depot architecture is SOP-aligned, but procedure approval remains a business control. | Approve SOP updates referencing retained MRN/SMA and Depot-native records. | Future Control Required |
| UAT evidence required. | Build and browser checks are engineering verification, not formal user acceptance. | Execute UAT scripts for receiving, exceptions, disposition records, movements, reports, and search. | Future Control Required |
| Migration/import validation required if historical data is loaded. | Imported history may break identifiers, state buckets, quantities, or traceability chains. | Validate migration mapping, reconciliation totals, rejected/returned/disposed history, and audit provenance. | Future Control Required |
| Category | Evidence | Readiness Status |
|---|---|---|
| SOP alignment | MRN/SMA retained, paper registers replaced, and receiving flow presented as SOP-gated. | Implemented |
| State control | Only Released / Available inventory can be used; all other states are unavailable. | Implemented |
| Availability integrity | Physical, released, quarantine, hold, rejected, returned, disposed, and total accounted buckets are separated. | Implemented |
| Traceability | Traceability paths link receipt, inspection, exception, quarantine, QC, QA, inventory, return, and disposal records. | Implemented |
| Exception handling | Warehouse exceptions remain inside receiving and do not bypass quarantine, inspection, or authorized disposition records. | Implemented |
| Role clarity | Receiving, QA, Operations, and Security/Custody boundaries are visible. | Partially Implemented |
| Audit trail readiness | Status history and activity evidence show user, timestamp, previous state, new state, reason, and record linkage. | Partially Implemented |
| Report readiness | Receiving, inspection, quarantine, QA disposition, exception, hold, missing documentation, return, disposal, SMA, and consistency reports exist. | Implemented |
| Persistence readiness | Identifiers, relationships, states, evidence sections, and gap register identify future persistence controls. | Future Control Required |