Name: Indonesia Pharmaceuticals
Brand: TraceLink
Availability: OnlineOnly

Products

Advanced compliance data management and reporting solution for Indonesia pharmaceutical track-and-trace compliance

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Product overview

Comply with Indonesia’s serialization and reporting requirements

TraceLink Indonesia Pharmaceuticals leverages our global compliance platform to help pharmaceutical manufacturers meet the evolving data management and compliance reporting requirements documented by BADAN POM (BPOM) for submission of product and operational data to the BPOM system.

With Indonesia Pharmaceuticals, you can:

Confidently meet Indonesia traceability requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from regional compliance demands

Industry challenges

New compliance requirements demand new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in Indonesia. These challenges include:

Complex national labeling and reporting requirements

Pharmaceutical companies must comply with labeling requirements for serialization and reporting certain events to the National Agency of Drug and Food Control (BPOM) Track and Trace Anti-Counterfeit (TTAC) website.

Complex national labeling and reporting requirements

Product marking and reporting based on classification

There are two aspects of product marking, data management, and reporting: identification to verify the legality of a product, and authentication to verify a product’s authenticity by GTIN, batch (lot) number, expiry date, and serial number.

Product marking and reporting based on classification

Ambiguous compliance requirements and processes

The specific compliance requirements, data management processes, and reporting needs for companies with products in the authentication category are still evolving, requiring frequent updates from manufacturers.

Ambiguous compliance requirements and processes

Product benefits

Monitor, scope, develop, and deliver in uncertain markets

TraceLink has proven its ability to monitor, scope, develop, and deliver compliance solutions for the most complex markets and for the regulatory regimes that are the most uncertain in terms of scope and timelines. More than 600 pharmaceutical manufacturers use TraceLink as their global serialization and compliance platform.

Product benefits

Ensure continuous compliance with a flexible platform architecture

TraceLink’s network-tenant architecture enables manufacturers to “Integrate Once, Interoperate with Everyone™” so they can quickly onboard their contract partners and deploy market-specific packaging data. Platform integrations with CMOs are maintained by TraceLink, ensuring the platform remains functional through CMO system upgrades and TraceLink system upgrades.

Product benefits

Lay a scalable foundation for global compliance

The TraceLink global compliance platform provides a flexible, modular foundation for rapid development and deployment of regulatory compliance solutions. The platform's design was informed by over a decade of delivering trusted compliance solutions for the most complex and evolving compliance requirements.

Capabilities

TraceLink Indonesia Pharmaceuticals

Since 2009, TraceLink has been the industry leader in delivering regulatory compliance and serialization solutions for the global pharmaceutical industry in more than 30 countries.

Manage workflows and data

Automate and customize reports

Streamline report submission

Utilize flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements.

Generate formatted compliance reports for the National Agency of Drug and Food Control (BPOM) Track and Trace Anti-Counterfeit (TTAC) website.

Automate or manually generate reports.

Search, view, and and analyze compliance data and current and historical reports including in-depth information on:
Report Type
Aggregation Hierarchy
Lot Numbers
Serial Numbers
Shipment Information
Packaging Codes and other Product Information
Utilize audit trailing of submitted reports and system
responses