Electronic Data Interchange (EDI) – Automating B2B Orders, Shipments, and Invoices

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • Integration & Supply Chain • WMS, MES, QMS

Electronic Data Interchange (EDI) is the structured exchange of business documents between organizations—creation, transmission, acknowledgement, reconciliation, retention, and archival. It is the connective tissue of commercial execution: orders that define what shall move, confirmations that prove what actually moved, and change processes that keep both synchronized with physical operations. In practice, “EDI” spans standardized messages (e.g., X12 850, 856, 810), partner-specific guides, label masters (GS1-128/SSCC), item/pack hierarchies, and governance artifacts such as Change Control and CAPA. It must demonstrate ALCOA+ principles and comply with 21 CFR Part 11 / Annex 11 when electronic records impact regulated distribution.

“If you cannot show who sent what, when it was accepted, which version was in force, and how the shipment links back, you don’t have EDI—you have email.”

1) What It Is

At its core, EDI ensures that the right document reaches the right system at the right time, and that obsolete mappings cannot be mistakenly used. Standard transactions include purchase orders, advance ship notices, invoices, warehouse requests/confirmations (3PL), product/price catalogs, and functional acknowledgements (see CSV and validation of interfaces). Executed records—e.g., pick confirmations, release holds, pack contents, label serials—must trace to the partner and guide version in force and be preserved per your Data Retention & Archival policy.

2) Regulatory Anchors & Scope

Predicate rules for distribution and records (e.g., 21 CFR 210/211, devices 820, food 117 / supplements 111) require accurate records and control of change. When these are electronic, Part 11 and Annex 11 add identity, security, audit trail, signature, and retention expectations. EDI therefore covers:

• Authoring & change of partner maps (codes, packs, units, price, UOM, labels).
• Distribution & access to current guidelines and test packs for implementers.
• Execution of warehouse/manufacturing events into messages (e.g., 856, 945).
• Linkage between physical shipment and EDI via SSCC, lots, and audit trail.
• Periodic review to keep maps current with partner and regulatory reality.
• Retention & archival ensuring readability and context for the required period.

3) Integration Lifecycle: From Mapping to Go-Live

Creation & numbering. Maps are authored against templates so structure is consistent (segments, qualifiers, loops, examples, acknowledgements). Each partner/flow receives a unique ID, title, and classification (PO/ASN/Invoice/3PL), and is mapped to customers, items, and locations for impact analysis. Controlled fields for related masters—e.g., BOM pack rules or label artwork—ensure later linkage.

Review & approval. Content moves through role-based Approval Workflow (author → technical reviewer(s) → QA/IT → commercial). Review enforces clarity and testability; QA verifies alignment with validation status (CSV) and related procedures. Approvals require unique electronic signatures with meaning and timestamp under Part 11 controls.

Effective dating & training. A deployment date balances chargeback risk with readiness. Training needs are derived automatically from message class; teams are assigned by role/location and must complete training before the guide is effective for them. Systems may enforce training gating—preventing ASN/invoice submission until training is complete.

Distribution & control of copies. Implementers access current maps through the system; printed controlled copies are watermarked with version and validity windows. Obsolete versions are automatically superseded and made read-only (retained for history, not use).

Revision & change control. Revisions follow formal Change Control with impact assessments on labels, training, ERP/MES/WMS interfaces, and risk documents (HACCP/FMEA). Minor vs major changes dictate approval depth and whether revalidation is required. The system maintains redlines, revision history, and rationale with audit trails.

Archival & decommissioning. On retirement, maps and their metadata (version history, signatures, trails, effective periods) are archived per policy. For electronic systems, format sustainability and rendering capability (viewer) are validated; see Retention & Archival.

4) What Messages Are In Scope (Examples)

• Ordering & pricing: 850 Purchase Order, 832 Catalog/Price, 855 PO Acknowledgement.
• Warehouse & 3PL: 940/943/944/945 requests, receipts, and ship confirms; ASN alignment.
• Shipping & labeling: 856 ASN with pack hierarchies, lots/expiry, SSCC/GS1-128 labels.
• Billing: 810 Invoice tied to shipped lines, terms, and taxes; credit/debit memos.
• Control & status: 997/CONTRL, error reports, partner performance dashboards.
• IT/CSV: interface validation, data integrity, security, backup/restore, continuity.

5) Technical Controls for EDI Interfaces

• Identity & access. Unique users, role-based permissions, endpoint keys; no shared accounts.
• Audit trails. Immutable logs for translations, acknowledgements, retries, corrections; reason-for-change capture. See Audit Trail (GxP).
• Electronic signatures. Part 11-compliant approvals for maps and go-lives, linked to records with meaning and time zone.
• Versioning & supersede logic. Automatic effective/retire states; enforced withdrawal of obsolete partner maps at runtime.
• Linkage to execution. Picks, packs, and labels bind to the partner version in force; ASNs and invoices pull from approved data via controlled interfaces.
• Training controls. Role mapping to partner flows; completion gating; periodic retraining on major revisions.
• Search & retrieval. Full-text and metadata filters (partner, flow, status, owner); rapid rendering for inspection.
• Integration. Validated exchange with MES/LIMS/WMS/ERP via the V5 Connect API, with acknowledgements and field-level mapping.

6) Common Failure Modes & How to Avoid Them

• Shadow mappings. Uncontrolled spreadsheets and sidecar scripts. Fix: centralize in controlled repository; retire and migrate with review.
• Obsolete guides at point of use. Old label formats or codes. Fix: runtime version enforcement, expiry watermarks, scan-back on use.
• Mismatched labels/specs. Pack rules updated but label artwork lags. Fix: bind label content to approved pack and enforce Approval Workflow.
• Weak change control. “Quick fixes” that alter semantics. Fix: classify changes, require impact assessment, redlines, and QA/IT approval.
• Training not synchronized. New guide effective before training. Fix: training gating and effectiveness checks.
• Broken traceability. ASN references superseded codes. Fix: lock shipment-to-guide link at confirm and record version in the dossier.

7) Metrics That Prove Control

• First-pass ASN acceptance and chargeback rate by partner.
• Training completion before effective date (% users trained on time).
• Obsolete-at-use incidents (attempted use of retired maps or labels).
• Change-control cycle time and recurrence of CAPAs tied to EDI defects.
• Inspection retrieval time to render a complete set (guide + records + trails).

8) How It Relates to V5

V5 by SG Systems Global embeds EDI across MES, QMS, and WMS. In V5 WMS, pick tasks and FEFO are generated from partner demand; version-in-force is locked at pick start; Dual Verification and scan checks govern critical actions; Barcode Validation ensures the right item/pack pairing. In V5 QMS, partner guides follow structured Approval Workflows, periodic reviews, and training assignments; Change Control links revisions to risk, validation, and downstream systems. In V5 MES, status labels, pack instructions, and Directed Picking are version-controlled; transactions are blocked if linked guides are obsolete. Across the platform, Part 11/Annex 11 audit trails capture authorship, approvals, and effective states. For APR/PQR, V5 renders EDI change histories, training status at time of change, and evidence that shipment execution used the correct versions.

9) FAQ

Q1. Are EDI acknowledgements required for compliance?
They are required by most trading programs and are a best practice for data integrity. Acks prove receipt/acceptance and support audit reconstruction.

Q2. Can we use email/PDF to avoid Part 11?
Email reduces scope but increases risk: hybrid models create uncontrolled transcriptions and lost context. When electronic source data exist, regulators expect electronic controls at source.

Q3. How often should we do periodic review?
Risk-based—typically 1–3 years by flow. Triggers include partner updates, regulatory changes, or recurring chargebacks.

Q4. What proves the right guide/version was used?
System evidence: shipment references to guide IDs/versions; label prints bound to approved templates; audit-trail entries for effective/retired states; training completion prior to use.

Q5. How do we manage multi-language labels and local variants?
Treat each label as a controlled derivative linked to a global master; changes to the master trigger synchronized updates and training across locales.