Certificates of Analysis (CoA), Safety Data Sheets (SDS), Certificates of Conformance or Origin, FAA/EASA forms, microbiology reports and allergen statements aren’t just attachments – they are the evidence your business relies on to ship, sell and defend product quality. In regulated industries such as chemicals, aerospace, pharma and consumer goods, documentation proves that each lot meets specifications and complies with standards. Yet in many organizations these records still travel by email, sit in vendor portals or hide inside enterprise‑resource planning (ERP) attachments. The result is wasted time, duplicated effort, wasted times and efforts, compliance gaps and, in the worst cases, shipment delays, recalls and reputational harm.

The drag everyone feels (and the numbers behind it)

• Employees spend too much time hunting for information. A McKinsey Global Institute report found that interaction workers spend nearly 20% of the workweek searching for internal information. When companies adopt collaborative tools and unified search, the time spent searching can drop by up to 35%, raising worker productivity by 20–25%.

• Not finding the right file is expensive. An IDC white paper estimated that a 1,000‑person enterprise wastes US$2.5–3.5 million per year searching for non‑existent information, failing to find existing documents or recreating what cannot be found. These losses occur before counting opportunity cost or compliance penalties.

• Poor quality costs real money. The American Society for Quality notes that many organizations have quality‑related costs as high as 15–20% of sales revenue, with some operations reaching 40%. These costs include prevention, appraisal and failures – and incorrect or missing certificates contribute directly to failure costs.

These figures aren’t abstract; they materialize as overtime for quality teams, delayed shipments, chargebacks, blocked lots, fines and anxious audit preparation. Product recalls are just one of many downstream risks. Industry analyses estimate that a typical recall can cost millions of dollars in direct costs and far more when reputational damage and lost sales are considered—yet the bigger story is how much time and money are wasted before failure occurs.

Why quality documents are still hard in 2025

• Multi‑party sprawl. Suppliers email PDFs, some require logins to their portals, laboratories send results separately and brokers add yet another link. The same CoA gets copied across inboxes and shared drives, with nobody certain which version is final.

• Heterogeneous content. CoAs vary widely in layout, test methods and units; specifications change; units don’t convert themselves.

• Systems treat evidence like an attachment. Traditional ERP or warehouse‑management systems “store a PDF” but don’t validate ranges, map methods/units or expose lot‑level traceability across suppliers and customers.

• Audit and data‑integrity expectations keep rising. GxP guidance such as ALCOA/ALCOA + requires quality data to be Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available. Email threads and shared folders were never designed for that level of traceability.

Who hurts the most—and how

• Head of Quality & Compliance: Chasing documents; triaging spec mismatches; preparing for audits; needing version truth, signatures and access logs on demand.

• Head of Operations / Plant / Logistics: Cannot ship without the right CoA; hates holds and rework caused by missing or wrong paperwork; wants straight‑through processing and exception alerts.

• Customer Operations / Sales Ops: Gets the angry call when customers cannot find the documentation; needs a simple, branded way to share validated certificates instantly.

• IT / Data / Compliance: Must keep the ERP as the system of record while ensuring identity, access control and a defensible audit trail across multiple counterparties.

What “good” should look like

• Ingest anywhere → normalize once. Email, SFTP, vendor portal or EDI – all certificates land in one place.

• AI extraction with specification intelligence. Read any CoA layout, map tests/units/methods, convert units and flag out‑of‑range results automatically.

• Review only the exceptions. Provide human‑in‑the‑loop review for low‑confidence fields and rule failures, with side‑by‑side source versus extracted data.

• Publish with trust. Digitally sign, optionally edit‑protect and share to customer‑specific portals; log every view and download.

• Traceability across parties. Link documents to purchase orders, advanced shipment notices (ASN), lots and sites, and keep an immutable chain so audits take hours, not weeks.

• ERP‑friendly. Keep the ERP or quality management system as the system of record; let a quality network provide the rails and guardrails for multi‑party evidence.

Introducing QualiNex — the Quality & Compliance Network

QualiNex is an AI‑powered network for quality documentation, built to eliminate the email/portal sprawl and give every stakeholder a single, trusted source of truth.

• Agentic intake. From inbox, portal, SFTP or EDI into structured, searchable records.

• Spec‑aware validation. Automatically check ranges, units and methods; highlight outliers; route exceptions.

• Digitally signed sharing. Publish to branded customer portals with granular access control and complete logs.

• Lot/PO/ASN links. Trace a certificate back to its source and forward to every shipment it supports.

• Analytics & recall readiness. See pass/fail trends by supplier, product or site; run recall drills; identify bottlenecks.

• Works with your stack. Keep ERP/WMS/LIMS as your system of record — QualiNex is the quality rail plus guardrails.

What you can expect to improve

• Lower handling costs. Less time spent searching, copying and recreating documents; more straight‑through passes. Unified search and knowledge‑sharing can raise productivity by 20–25% and reduce wasted labor.

• Fewer delays and write‑offs. Specification mismatches and missing documents get caught upstream, before they become holds or chargebacks.

• Audit confidence. Every document is signed, versioned and tied to a clear access log – aligned with ALCOA/ALCOA + expectations.

• Brand protection. Better documentation integrity reduces risk factors that can trigger costly product recalls and reputational damage.

Join the early‑access cohort (and help shape the network)

We are inviting manufacturers, laboratories, distributors and importers/exporters to the QualiNex early‑access program. Founding members receive:

• Priority onboarding: Templates, specification libraries and mappings tailored to your products.

• Influence on the roadmap: Help shape support for tests, units and methods that matter to your business.

• Preferred pricing and migration support.

• Co‑marketing opportunities as a launch partner.

If your teams are tired of chasing CoAs, SDSs and other critical certificates—and want a future where quality evidence just flows—join the QualiNex early‑access program or apply to be a founding member. Let’s turn documents into dependable, shared truth so operations move faster, audits go smoother and quality scales.