F500 validates supply chain quality in hours across 20+ languages

A Fortune 500 pharma manufacturer deployed AI agents to validate CoAs across over 20 languages, cutting processing from days to hours, accelerating batch release and supply chain speed at scale.

Autonomous CoA execution
87% operational cost reduction
Full audit-ready
Trusted by industry leaders
Our process

The Journey to Autonomous Manufacturing Operations

A large global manufacturer faced a constraint at the heart of its supply chain: more than 580,000 Certificates of Analysis per year, arriving from thousands of suppliers in over 20 languages, each requiring validation before materials could be released into production.

The validation workforce had grown to the equivalent of 70 full-time employees. Every CoA required manual verification of test results against material specifications, cross-referencing of supplier data for policy compliance, and re-entry of validated values into SAP and the Laboratory Information Management System (LIMS). Cycle times stretched to 2–5 days per document. During peak intake periods, backlogs cascaded downstream, delaying production scheduling, holding up supplier payments, and creating audit exposure The cost base scaled linearly with supplier volume. Every new market, every new raw material, every new supplier added validation load with no efficiency gain. The operating model had reached its ceiling.

The Challenge

Volume, Variation, and Validation

The team was responsible for validating more than 580,000 CoAs per year, each with different structures, test parameters, and terminology depending on the supplier, material type, and country of origin.

At the equivalent of 70 full-time employees dedicated to the process, CoA validation had become one of the largest manual operations in the company's quality function. Each document required a trained product supply or engineering specialist to identify the relevant test results, verify values against material specifications, confirm supplier accreditation, and manually key validated data into SAP and LIMS. 

Cycle times averaged 2–5 days. During volume spikes, backlogs compounded. Materials sat in quarantine waiting for validation clearance, and production schedules absorbed the delay. 

Previous approaches to automating CoA intake, including template-based extraction and rules-driven validation, had fallen short. The sheer variation in supplier formats, languages, and test nomenclature made rigid, rule-based systems impractical at this scale.

The company needed a fundamentally different operating model: one that could validate CoAs autonomously across any supplier format and language, integrate directly into production systems, and scale with business growth rather than headcount.

The Solution

Autonomous AI Agents for CoA Validation

The company deployed Otera to establish autonomous, end-to-end CoA execution across its global supplier base.

Rather than automating individual steps in the validation workflow, Otera deployed a coordinated set of AI agents, each responsible for a distinct stage of the CoA lifecycle. These agents operate autonomously under governed rules, with human specialists reviewing only the exceptions the agents flag.

Classification and Field Mapping Agent. Each incoming CoA is classified by material type, supplier, and document structure. The agent identifies the relevant test parameters and maps them to the correct validation schema, regardless of language, layout, or terminology.

Extraction and Interpretation Agent. Test results, supplier details, and certificate metadata are extracted and interpreted across 20+ languages, handling variations in how suppliers report the same parameters (different units, naming conventions, formatting)

Validation and Compliance Agent. Extracted values are cross-referenced against material specifications, supplier qualification records, and internal quality policies. The agent verifies that every parameter falls within the defined acceptance range and flags deviations for escalation. This is where the core quality decision happens: accept, reject, or route to a human specialist with a pre-populated review screen.

System Integration Agent. Validated data is written directly into SAP and LIMS, eliminating manual re-keying entirely. Every data point carries a full audit trail from the original supplier certificate through to the production system record.

When the agents encounter a CoA that falls outside confidence thresholds or contains values that deviate from specification, the case is escalated to a human quality specialist. The specialist receives a pre-populated review screen showing the extracted data, the flagged deviation, and the applicable specification, reducing exception handling time from 15 minutes to under 3.

The Result

A New Default for CoA and Quality Operations

The impact reshaped the economics and speed of the company's supplier quality function.

Autonomous validation became the operational default. Over 80% of all inbound CoAs now flow from receipt through SAP and LIMS integration without human intervention. The remaining cases are routed to a specialist who handles the exceptions that require expert judgment.

That represents a reduction equivalent to shifting from 70 FTEs to 9: an 87% reduction in operational cost for CoA validation, with the redeployed capacity redirected toward supplier development, quality engineering, and proactive risk management rather than manual data verification.

Cycle times collapsed from 2–5 days to hours. Materials that previously sat waiting for CoA clearance now move through the quality gate within hours of receipt, keeping production schedules on track and reducing quarantine inventory.

Error rates dropped by 3.5x compared to the manual process. With no manual re-keying into SAP and LIMS, the primary source of data entry errors was eliminated entirely, strengthening the company's audit position and reducing supplier non-conformance disputes.

Direct system integration ensured that every validated data point is traceable, audit-ready, and available in real time across production planning and quality management systems.

Metric Before After
Equivalent workforce 70 FTEs 9 FTEs (87% cost reduction)
Validation handling time 15 min per CoA Autonomous (exceptions only: under 3 min)
Cycle time 2–5 days hours
Error rate Baseline 3.5x reduction vs. manual process
Autonomous execution rate 0% (fully manual) 80%+ touchless

Next Steps: From Insight to Action

Next Steps: From Insight to Action

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