B&D Life Sciences

B&D Life Sciences 

Oracle Pedigree and Serialization Manager

Oracle Platinum Partner

Business & Decision worked with Oracle to develop the initial business requirements and subsequent functional design for the Oracle Pedigree and Serialization Manager (OPSM). We have used our knowledge of industry drivers, regulatory requirements and the OPSM product to develop a 'Validation Pack' - to accelerate the implementation and validation of OPSM. This will allow regulated pharmaceutical and medical device companies to implement Oracle's industry leading serialization and ePedigree solution in the timescales needed to meet current and pending regulatory deadlines.

To learn more about OPSM and the Business & Decision Validation Pack for OPSM, click on the "Strategic Management of Product Serial Identifiers" webcast link below.

Track and Trace in Life Sciences

Business and Decision understand the increasing complex set of guidelines and regulations governing the distribution of Life Sciences products, intended to address issues such as counterfeiting, reimbursement fraud and loss of corporate reputation.

Depending on the product, geography and regulatory authorities, different Life Sciences organizations are keen to address multiple issues affecting the industry. These include:

  • Product Counterfeiting,
  • Medication errors,
  • Reimbursement fraud,
  • Fraudulent returns.

These issues not only have the potential for causing Harm to patients, but also result in loss of revenues, additional costs and loss of corporate reputation.

Against a background of increasingly complex local and national guidelines, industry standards (GS1, GS10), existing and proposed regulations (Standardized Numerical Identification - SNI, Unique Device Identification UDI etc), Life Sciences companies are anxious to put in place solutions that address issues of patient safety, allow costs to be managed and assure compliance.

Track and Trace Solutions

Various guidelines, standards and pending regulations propose solutions based around Pedigree or Mass Serialization. Meanwhile there are existing regulations requiring braille readable packaging, medical device serialization and machine readable identification and proposals which infer wholesale changes to the packaging and distribution model of many companies.

Business & Decision understand that regulations and guidance in the international Life Sciences market are asking for a lot of different things and that suppliers and distributors must incorporate all of these requirements into their packaging and distribution processes. While no single software vendor provides the complete solution, Business & Decision understand what is needed to solve the problem holistically, leverage component systems and integrate solutions.

Taking a strategic aproach, Business & Decision assist Life Sciences organizations to develop a Serialization Program, addressing not only the tactical issues, but the strategic people, process and technology concerns that are the prerequisite to succesfully rolling out a serialization or Pedigree solution.

Serialization Program Overview

From top-to-bottom, from Master Data Management via ERP and MES Systems through to on-line printing and scanning, using 2D barcodes or RFID and including the need to generate, manage and submit mass serial numbers on a global basis, Business & Decision understand the issues, maintain the partnerships and the knowledge to help clients develop cost effective Trace and Trace solutions in mutiple Life Sciences sectors.

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