End-to-End Compliance in Life Sciences & Pharmaceuticals

Many pharmaceutical and life sciences companies started their production processes automation long before “smart factory” was an established term. Yet, there is considerable potential for further optimisation, especially from a financial perspective, through the end-to-end integration of the SAP system. Quality checks and integrated batch management are key components.

A lot of production steps require a digital signature. With some instances this is obligatory, and the guidelines provide some leeway in other areas. Knowing and capitalising on this often leads to cost savings. This is the type of expertise that NTT DATA Business Solutions specialists have gained over many years through countless projects.

Big fraud cases around the globe have seen legislators step in and take action. With pharmaceutical product serialization, you need to go far beyond considering just the outer packaging. The inner packaging also needs unique identifiers, such as serial numbers.

When the packaging includes blister packs, costs can increase significantly. That’s because adding any data to this kind of packaging can require laser technology, which is far more expensive than standard labelling.

What are the mandatory processes? Where can you compromise? Being able to answer these questions can save you a lot of money.

Future focused companies are constantly developing new products with the right properties combined with the best possible cost structures. Enterprises can achieve their goals with less risk and greater cost efficiencies thanks to digitization and close collaboration with their business partners during the early development process.

However, the research and development must first be closely integrated into the existing IT landscape to ensure processes run smoothly.

Pharmaceutical companies must prove that every drug produced and shipped reaches the end pharmacy customer in its original condition. You must ensure traceability in batch management--from production to delivery--and guarantee that all products remain within the correct temperature range.

This is where the Internet of Things shines. Combined with temperature sensors and labelling, the IoT enables the product to be tracked throughout its lifecycle and be tested in real time. With SAP GBT, NTT DATA Business Solutions enables an effective and efficient analysis of complex chains. The batch management system links data from different sources and brings them together in one system.

Learn more in this infographic about GBT.

Pharmaceutical companies must validate their IT systems according to guidelines set out by the EU and the FDA. Unfortunately, the majority of decision makers are unsure which systems this applies to, and to what extent. This uncertainty can result in unnecessary costs.

NTT DATA Business Solutions has developed a cost-and risk-optimised project approach that can lead to financial savings of up to 40 percent.

Pharmaceutical industry serialization, international regulations and complex logistics, all drive the need for superior IT knowledge and solutions. ATTP (Advanced Track & Trace for Pharmaceuticals) fulfills your Serialization requirements. This innovative serialization and unit-tracking tool ensures medicine-producing companies can validate their products, integrate their business processes and collaborate with regulators and business partners.

The SAP Advanced Track and Trace for Pharmaceuticals application supports effective compliance with global pharmaceutical serialization needs. Life Sciences companies can help ensure patient safety with this solution.