AI-Powered Compliance Transformation for the Digital Enterprise
Birlasoft and Certivo empower organizations to achieve continuous regulatory compliance through an AI-driven platform that automates evidence collection, document validation, supplier collaboration, and regulatory reporting across complex global supply chains. By combining Certivo's AI-native compliance intelligence with Birlasoft's deep expertise in PLM, MES, ERP, Quality, and enterprise transformation, organizations can accelerate compliance readiness, reduce operational risk, and bring products to market faster.
Key Business Outcomes
- Accelerate compliance processes by automating supplier evidence collection and validation.
- Give executives real-time visibility into their global compliance stance, improving confidence in audit and regulatory outcomes.
- Achieve audit-ready documentation on demand across multiple regulatory frameworks.
- Reduce manual compliance effort through AI-powered document intelligence and workflow automation.
- Seamlessly integrate compliance into PLM, ERP, MES, LIMS, RIMS, and QMS ecosystems.
- Scale compliance operations without increasing compliance headcount.
Improve supplier engagement and regulatory readiness across global supply chains.
Certivo powers
PHARMA & MEDTECH · LIFE SCIENCES
AI-led compliance across the product lifecycle
One AI-powered platform unifying regulatory intelligence, product & supplier compliance, and lab traceability — delivered by Birlasoft’s life-sciences practice and powered by Certivo’s evidence engine. It collects, validates, monitors, and proves compliance from design through post-market, working bidirectionally inside the PLM and ERP systems you already run.
AI-POWERED
Compliance
- Supplier evidence read, validated, and kept current across 130+ regulatory frameworks and thousands of parts
- DHF & technical file readiness — ingest any requirement set, score existing files, guide engineers prospectively
- Every determination and supplier interaction logged with rationale — audit-ready by default
AI-POWERED
RIMS
- Regulatory change monitored continuously; affected evidence expired and re-collected automatically
- Registration and submission packages generated from validated data, in agency-specific formats
- Direct agency reporting with full confirmation tracking and submission history
AI-POWERED
LIMS
- Batch and lot-level traceability mapped to compliance scope and applicable test standards
- Lab, sterilization, and test evidence validated against requirements — not just filed
- Quality documentation connected to products, parts, and suppliers across the digital thread
ONE EVIDENCE LAYER, DESIGN TO POST-MARKET
Design
Applicable frameworks surface to engineers before decisions lock in.
Develop
Technical files and DHFs assessed for completeness as they’re built.
Market access
Declarations, certificates, and submissions generated from validated data.
Manufacture
Supplier evidence collected and validated continuously across the BOM.
Post-market
Regulatory change tracked; evidence never goes stale.
HOW IT WORKS · CERTIVO ENGINE
Collect
Validate
Monitor
Prove
Deterministic extraction, not generative guesswork. AI handles roughly 80% of the work; compliance experts review the rest by design — human-in-the-loop is the architecture, not a fallback.
130+
regulatory frameworks, 10 categories
25+
languages in supplier portal
80/20
AI-to-human split, by design
80–90%
faster evidence assembly
In production, not in pilot
Live deployments with global medical device and industrial manufacturers — processing thousands of supplier documents and managing agency reporting today.
Built into your digital thread
Bidirectional SAP and PTC integration — BOMs, vendor masters, and part mappings flow in; compliance statuses flow back to the source of record.
Need-to-do, not nice-to-have
In regulated markets, compliance isn’t optional. This platform turns a mandated cost into first-time quality, faster market access, and fewer audit findings.
Birlasoft brings expertise in life sciences delivery, PLM engineering, and regulated industry programs.
Certivo brings the AI-native evidence platform. One integrated solution, inside your existing stack.
Certivo powers
INDUSTRIAL MANUFACTURING
AI-led supply chain compliance, end-to-end
One AI-powered platform that collects, validates, monitors, and proves compliance across every part, supplier, and framework — delivered by Birlasoft and powered by Certivo’s evidence engine, working bidirectionally inside the SAP and PLM systems you already run. In production with industrial manufacturers today.
AI-POWERED
Materials & substances
- Full-BOM substance intelligence across 130+ frameworks — REACH, RoHS, PFAS, Prop 65, POPs, SCIP, PPWR
- Documents parsed at scale with SVHC threshold checks and expiry tracking
- Multilingual supplier campaigns with full email trails and scorecard portal
AI-POWERED
Responsible sourcing & CBAM
- Conflict minerals (CMRT/EMRT) with smelter context and risk levels
- CBAM: emissions data collected, calculated to Annex IV, declarations generated and filed
- Regulatory change monitored and acted on — evidence auto-expired and re-collected
AI-POWERED
Customer & agency proof
- Certificates of compliance and declarations generated from validated evidence
- Customer requests auto-drafted for human review — fail-safe when evidence is missing
- Agency reporting (e.g., SCIP/ECHA) with confirmation tracking and full lineage
THE 2026–2028 REGULATORY WALL (DATES VERIFIED JULY 2026)
In effect
CBAM definitive regime (Jan 2026); industrial battery carbon footprint (Feb 2026).
Aug 12, 2026
PPWR applies — product and transport packaging evidence obligations phase in.
By Jan 2027
US TSCA PFAS reporting window opens — a 2011–2022 lookback across suppliers.
2027
Machinery Reg. (Jan); Battery Passport & CBAM certificates (Feb); first CBAM declaration (Sep 30).
Dec 2027 +
EU Forced Labour Regulation applies; proposed CBAM expansion & EU PFAS restriction follow.*
HOW IT WORKS · CERTIVO ENGINE
Collect
Validate
Monitor
Prove
Deterministic extraction, not generative guesswork. AI handles roughly 80% of the work; compliance experts review the rest by design — human-in-the-loop is the architecture, not a fallback.
130+
regulatory frameworks, 10 categories
25+
languages in supplier portal
80/20
AI-to-human split, by design
80–90%
faster evidence assembly
In production, not in pilot
Live with motion-control, sensing & instrumentation, and diversified industrial manufacturers — inside SAP environments, with Birlasoft-led integration.
Built into your systems
Bidirectional SAP and PTC integration — BOMs, vendor masters, and part mappings flow in; compliance statuses flow back to the source of record.
Need-to-do, not nice-to-have
Compliance budget already exists — it’s being spent on headcount. This platform turns it into faster customer answers and audit-ready evidence.
Birlasoft brings enterprise delivery, SAP/PTC integration, and multi-OpCo rollout muscle.
Certivo brings the AI-native evidence platform, in production with industrial manufacturers today.
Transform Compliance with AI
Register your interest, and we will get in touch with you to help you understand how intelligent automation strengthens GxP compliance while accelerating innovation across the digital enterprise.
Connect with us
Tell Us a Little About Yourself