OpenText Core Signature - OpenText Product Traceability Integration and Automation

Common Integration Use Cases Between OpenText Core Signature and OpenText Product Traceability

OpenText Core Signature and OpenText Product Traceability complement each other well in regulated, quality-driven, and audit-sensitive environments. Core Signature handles legally binding approvals, while Product Traceability manages product genealogy, lot tracking, compliance records, and traceability events. Together, they help organizations connect approval workflows with product lifecycle control and evidence management.

1. Electronic approval of product release and batch disposition documents

Product Traceability can generate batch records, inspection results, deviation reports, and release documents that require formal approval before product shipment. These documents are routed to OpenText Core Signature for legally binding sign-off by quality, manufacturing, and regulatory stakeholders. Once signed, the approved record is returned to Product Traceability and linked to the batch or lot history for audit readiness.

• Data flow: OpenText Product Traceability to OpenText Core Signature, then back to OpenText Product Traceability
• Business value: Faster release cycles, reduced paper handling, and stronger compliance evidence

2. Controlled sign-off for nonconformance and corrective action workflows

When Product Traceability identifies a nonconformance, exception, or traceability gap, the related investigation and corrective action documents can be sent to OpenText Core Signature for formal approval. This ensures that quality managers, plant leaders, and compliance officers sign off on containment actions, root cause analysis, and disposition decisions. Signed records are stored with the traceability case to support audits and internal reviews.

• Data flow: OpenText Product Traceability to OpenText Core Signature and back
• Business value: Clear accountability, faster issue closure, and improved audit defensibility

3. Supplier certification and compliance document approval

Supplier quality documents such as certificates of analysis, declarations of conformity, and approved supplier agreements can be managed in Product Traceability and routed through Core Signature for approval by procurement, quality, and regulatory teams. Once signed, the documents are associated with supplier records, incoming material lots, or approved component lists. This creates a controlled approval trail for supplier onboarding and ongoing qualification.

• Data flow: OpenText Product Traceability to OpenText Core Signature, with signed output returned to OpenText Product Traceability
• Business value: Better supplier governance, reduced compliance risk, and faster onboarding of compliant materials

4. Customer-specific product specification approval

For products manufactured to customer requirements, Product Traceability can store specification sheets, labeling requirements, and special handling instructions. These documents can be sent to Core Signature for approval by product management, legal, and customer service teams before being activated in production. Signed approvals are then linked to the relevant product or customer order to ensure manufacturing follows the authorized version.

• Data flow: OpenText Product Traceability to OpenText Core Signature and back
• Business value: Fewer specification errors, improved customer compliance, and stronger version control

5. Electronic approval of traceability exceptions and waiver requests

When traceability data is incomplete or a process deviation occurs, Product Traceability can trigger a waiver or exception request that requires formal approval. OpenText Core Signature captures the required signatures from quality assurance, operations, and regulatory approvers before the exception is accepted. The signed waiver is then attached to the affected lot, shipment, or production run for future reference.

• Data flow: OpenText Product Traceability to OpenText Core Signature and back
• Business value: Faster exception handling, controlled risk acceptance, and complete documentation

6. Approval of recall and field action documentation

In the event of a recall or field corrective action, Product Traceability provides the affected lot, shipment, and customer distribution data needed to prepare formal recall notices and response documents. These documents can be routed through Core Signature for approval by legal, quality, and executive stakeholders before release. Signed recall records are then stored with the traceability case to support regulatory reporting and post-event analysis.

• Data flow: OpenText Product Traceability to OpenText Core Signature, then back to OpenText Product Traceability
• Business value: Faster recall execution, reduced legal exposure, and stronger regulatory response

7. Audit-ready approval archive for regulated product history

Product Traceability can act as the system of record for product genealogy, while Core Signature provides the signed evidence for key decisions across the product lifecycle. Integration allows signed approvals for release, deviation, supplier qualification, and change control to be automatically linked to the relevant traceability record. This creates a complete audit package that can be retrieved quickly during inspections or customer audits.

• Data flow: Bi-directional
• Business value: Centralized evidence, faster audit response, and reduced manual document reconciliation

8. Change control approval for product and process updates

When product formulations, packaging, serialization rules, or traceability requirements change, Product Traceability can initiate a change control workflow and send the approval package to Core Signature. Stakeholders sign off on the change request, implementation plan, and effective date before the update is released into production. The approved change record is then synchronized back to Product Traceability to ensure traceability rules remain aligned with the current process.

• Data flow: OpenText Product Traceability to OpenText Core Signature and back
• Business value: Controlled change governance, reduced production risk, and consistent traceability compliance