Turn every product change into governed, audit-ready proof
Birlasoft AI-Powered PLM Regulatory Compliance with Certivo CORA brings regulatory intelligence, supplier evidence, human assurance, and enterprise integration together in one connected flow across the product digital thread. It helps teams identify impact earlier, validate and refresh evidence, govern decisions, and produce audit-ready proof—without replacing core systems.
Core Capability Areas
| Core Capability | Enables |
| Sense & assess | Monitor regulatory change and map impact to products, parts, materials, suppliers, markets, and engineering changes. |
| Collect & validate | Automate multilingual supplier outreach, evidence intake, document validation, and expert exception review. |
| Connect & govern | Link trusted evidence and decisions with PLM, ERP, QMS, LIMS, RIMS, and supplier ecosystems. |
| Monitor & refresh | Track regulatory updates and expiring evidence, then trigger re-collection before proof becomes stale. |
| Prove & improve | Assemble audit-ready proof on demand and strengthen governance, adoption, and compliance operations over time. |
Earlier Insight. Trusted Evidence. Audit-Ready Proof.
| Impact Area | Business Value |
| Regulatory impact response | See affected products, suppliers, and markets earlier so teams can make faster, more confident decisions. |
| Evidence availability | Bring validated supplier and compliance evidence into the systems where teams already work. |
| Audit readiness | Maintain clear lineage across requirements, product records, evidence, expert decisions, and exceptions. |
| Operational resilience | Refresh expiring evidence and standardize governed workflows across products, suppliers, plants, and regions. |
Where Compliance Breaks Down
See the challenge, the connected response, and the value delivered
Regulatory change reaches teams faster than systems can respond
Challenge
Compliance, engineering, and supply chain teams struggle to determine which products, parts, suppliers, and markets are affected.
Our Approach
The offering continuously monitors regulatory change and maps impact to product structures, supplier records, markets, and engineering-change workflows.
Value Delivered
Earlier visibility into regulatory impact and faster, more confident product decisions.
Compliance evidence is fragmented across systems and suppliers
Our Approach
The offering connects validated evidence across PLM, ERP, QMS, LIMS, RIMS, supplier portals, and engineering workflows without replacing systems of record.
Value Delivered
One governed evidence trail linked to the correct product, material, supplier, and engineering change.
Manual supplier follow-up slows compliance response
Challenge
Teams spend significant time requesting declarations, tracking responses, checking expiration dates, and reconciling conflicting versions.
Our Approach
The offering automates multilingual supplier outreach, evidence intake, document validation, expiration monitoring, and re-collection—routing judgment-based exceptions for human assurance.
Value Delivered
Less manual effort, faster evidence-pack preparation, and stronger audit readiness.
One Connected Compliance Offering Across the Product Digital Thread
Birlasoft AI-Powered PLM Regulatory Compliance with Certivo CORA brings regulatory intelligence, supplier evidence, human assurance, and enterprise integration together in one connected flow across the product digital thread
How the Connected Compliance Flow Works
- SENSE & ASSESS: Monitor regulatory change and map its impact to products, parts, materials, suppliers, markets, and engineering changes.
- COLLECT & VALIDATE: Automate multilingual supplier outreach, parse and validate evidence, and route exceptions for human review.
- CONNECT & GOVERN: Link trusted evidence and decisions with PLM, ERP, QMS, LIMS, RIMS, and supplier ecosystems while maintaining traceability.
- MONITOR & REFRESH: Track regulatory updates and expiring evidence, then trigger re-collection before compliance proof becomes stale.
- PROVE & IMPROVE: Assemble audit-ready proof on demand and continuously strengthen governance, adoption, and compliance operations.
How Birlasoft Creates Business Value
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 Connected Capability |  What the Offering Delivers |  Where It Connects |
Regulatory change impact | Maps regulatory requirements to products, BOMs, suppliers, markets, and engineering changes. | PLM and the product digital thread |
Supplier evidence automation | Supports multilingual outreach, intake, validation, expiration tracking, and re-collection. | Supplier and quality ecosystems |
Enterprise evidence governance | Synchronizes trusted evidence, status, decisions, and exceptions across connected systems. | PLM, ERP, QMS, LIMS, and RIMS |
Audit-ready assurance | Routes expert exceptions and preserves decision rationale in a traceable compliance record. | Governed compliance workflows |
Why Birlasoft
One connected offering—from regulatory signal to governed execution across the product digital thread
- Deep manufacturing, engineering, PLM, integration, and enterprise-transformation expertise.
- Certivo CORA capabilities embedded within product, supplier, engineering-change, quality, and operational workflows.
- Technology-agnostic integration that keeps PLM and other core systems of record in place.
- Governance, adoption, human assurance, and managed operations designed for enterprise scale.
- 30+ years of industry and technology experience, 10,000 engineers, and a global delivery footprint.
How Birlasoft Delivers
Assess the compliance landscape, connect intelligence, evidence, data, and workflows, establish governance and human assurance, and scale the operating model across products, suppliers, plants, and regions
Delivery model: Assess | Architect | Integrate | Govern | Operate
FAQs
It is one connected offering that brings regulatory intelligence, supplier evidence, human assurance, and enterprise integration together across the product digital thread.
It senses regulatory change, assesses product and supplier impact, collects and validates evidence, connects governed decisions to enterprise systems, monitors expirations, and assembles audit-ready proof.
The offering can integrate with Product Lifecycle Management, Enterprise Resource Planning, Quality Management, Laboratory Information Management, Regulatory Information Management, and supplier systems.
No. It connects regulatory intelligence and trusted evidence to existing systems of record so teams can continue working within established platforms and processes.
Certivo CORA is embedded across the regulatory-intelligence and evidence lifecycle to monitor change, support multilingual supplier outreach, validate evidence, track expirations, and trigger re-collection. Birlasoft connects these capabilities to product and enterprise workflows, applies governance and human assurance, and scales operations.
Engineer compliance into every change
Explore how Birlasoft AI-Powered PLM Regulatory Compliance with Certivo CORA connects every product change to audit-ready proof.
Talk to Birlasoft experts