VerifyBrand™ : Ensuring Trust and Compliance for the pharmaceutical industry

WHAT IS THE PURPOSE OF AN L4-L5 SOFTWARE?

An L4-L5 software is essential for ensuring efficient, compliant, and cost-effective operations in the highly regulated and complex pharmaceutical industry.

It helps manage and optimize production operations at the corporate level by:

Seamlessly integrating and coordinating business systems with operational processes.
Ensuring data integrity, traceability, and audit readiness to achieve full regulatory compliance.
Exchange serialization data with your supply chain partners
Optimizing production to reduce downtime and maximize efficiency.
Delivering real-time, insightful data analytics to support decision-making.

GET COMPLIANT WITH VERIFYBRAND™

Compliance is paramount in the pharmaceutical industry yet achieving and maintaining compliance can often pose significant challenges. It is a fundamental aspect of companies’ operations as it underpins essential elements such as :

Product Safety
Brand protection
Regulatory approvals
Product quality

These elements ensure companies a strong and enduring market presence.

The pharmaceutical industry is highly regulated, with many layers of compliance to prevent product tampering and, ultimately, save on costs. However, companies can only truly reap these rewards if they carefully select serialization partners and solutions.

OPTEL’s patented solution VerifyBrand™ is a one-stop shop to connect to all regulators, coordinating compliance between plants (MAH, CMO, CPO, 3PL) and sending relevant data directly to government authorities.

VerifyBrand™ supports over 10 life sciences regulations, including US DSCSA and EU FMD.

Laptop,Blank,Screen,Mockup,,Vaccine,Bottles,,Medical,Books,On,Doctor

US DSCSA

To combat this growing problem and to reinforce the security of the drug distribution chain, the FDA introduced the Drug Supply Chain Security Act (DSCSA). It has already brought massive changes in the pharma supply chain operations with the introduction of mandatory serialization and track & trace requirements.

As part of DSCSA, all drug wholesalers must verify the authenticity of the serialized product identifier with the manufacturer. The verification router service (VRS) allows distributors and supply chain actors to verify manufacturer serial numbers without receiving and storing serial numbers in their own system. As a manufacturer, VerifyBrand can help automate verification requests by integrating with the VRS network and track verifications executed by supply chain actors.

Have a look at our dedicated guide for more information on the US DSCSA.

HOW VERIFYBRAND™ CAN HELP YOU WITH DSCSA

OPTEL’s patented solution VerifyBrand™ ensures full compliance with DSCSA requirements.

How TruPharma Gained Control of DSCSA Compliance

Case Study

DOWNLOAD

Hand,Of,Female,Doctor,Holds,White,Pills,Or,Tablets,Jar

OTHER REGULATIONS

WE COVER OTHER PHARMACEUTICAL REGULATIONS INCLUDING

Uzbekistan’s ASL BELGISI
Kazakhstan’s OMS
Bahrain NHRA
China
EU FMD
Russia

WHAT MAKES VERIFYBRAND™ SOFTWARE UNIQUE

EASY TO LEARN

Onboard training included
Upgrade support and documentation
Technical support available anytime

EASY TO USE

Intuitive user-interface
Available in several languages
Cloud based SaaS making it very flexible
Automated workflow

EASY TO BUDGET

Fixed-fee cost model
Pricing structure transparent
Free upgrades

EASY TO TRACK

Track and trace module
Regulation compliance guaranteed
Partners insights to leverage actionable intelligence
Leveraging the GS1 EPCIS standard

EASY TO MIGRATE

Provides the right solution for data migration project
Online data transfer and offline data transfer needs addressed
Data is physically or logically segregated from other clients’data
Scalable and secure (adheres to OWASP Secure Coding’s practices)
Dedicated account management
Turnkey partner integration

EASY TO DRIVE PERFORMANCE

Single-tenant architecture
Highly configurable with modules and adds-on
Built-in and advanced analytics reporting
Fast response for items batch history and serial numbers queries
Execution against customer timelines
No delayed deployments

WHY VERIFYBRAND™ IS THE SOLUTION YOU NEED

For over two decades, OPTEL’s patented VerifyBrand™ solution – an enterprise-level serialization and traceability solution – has empowered leading global brands to track products, safeguard assets, and ensure regulatory compliance.