Pharmaceuticals

Solutions

Sage X3 ERP is a robust and highly configurable ERP system suitable for the pharmaceutical industry. With a focus on compliance, Sage X3 ensures adherence to industry regulations, including the complex requirements of the FDA. The system’s capabilities span from comprehensive traceability and job costing to navigating the ever-evolving regulatory landscape, providing pharmaceutical enterprises with a feature-rich platform for streamlined operations. Notably, Sage X3 excels in addressing challenges unique to the sector, such as the management of contract manufacturing arrangements, regulatory compliance reporting, and the intricate processes associated with New Product Innovation (NPI).

A standout feature of Sage X3 is its compliance with 21 CFR Part 11, a critical regulation from the U.S. FDA. The system’s functionalities, including extensive transaction audit trails, digital signatures, and document signatures, align with the stringent requirements of Part 11. Moreover, Sage X3 goes beyond regulatory compliance, offering comprehensive solutions for CAPA management, ensuring the quality control of pharmaceutical products, and seamlessly integrating with weighing scales for secure and traceable operations. With its focus on efficiency, compliance, and innovation, Sage X3 emerges as a strategic choice for mid-sized pharmaceutical enterprises seeking a reliable ERP solution to navigate the intricacies of their industry.

BatchMaster for SAP Business One

The BatchMaster for SAP Business One solution includes the ability to manage adverse events and customer complaints. The system also holds additional supplier information concerning their capabilities and verification (under cGMP compliance) and supports issuance of warnings in cases when the verification becomes outdated. From a manufacturing perspective, the extension supports capturing of downtime with reason codes to improve manufacturing efficiencies. The system produces a print weighing sheet after materials are weighed with information of lots and quantity weighed, weighed by & checked by.

The electronic batch ticket aids with tracking labour in and out times. The system also specifically deals with product development involving soft & hard gel capsules, tablets, powders, and syrups.

With controlled sampling, a common requirement amongst manufacturers of nutraceuticals & pharmaceutical products, the BatchMaster for SAP Business One system extension enables you to deduct materials from QC Samples to help draw quality control samples from the total quantities of materials received. The system manages Inspection plans, & NC and CAPA form printing to get details of non-conformance identified in product, service, or process flows. There is a separate CAPA form to record processes undertaken to eliminate causes of nonconformity and to advance excellence.

BEAS for SAP Business One

With the Boyum Solution for pharmaceutical product manufacturing the complex storage requirements of each perishable product with precise temperature and humidity storage can be accurately managed.

The system manages batch and serialized items for full traceability to protect you against falsification and counterfeit products. A standardized warehouse management system registers all inbound, internal, and outbound logistics movements of products based on industry standards, thus ensuring full traceability.

The system reduces the work effort associated with compliance with governments and regulatory bodies. Boyum BEAS for pharmaceutical manufacturers can be validated against the prevailing industry standards (GAMP 5). The system helps produce accurate information in an open and transparent manner with data captured in real time.

Companies operating more broadly in the life sciences sector often face real challenges around calculating product margins. Boyum BEAS for SAP Business One supports capture of real time costs at the batch level generating granular level cost visibility. With the Boyum BEAS for SAP Business One system you can capture, assign and compare actual and standard costs for all finished products. This includes not only material costs but also labor, machine, and overhead costs as well. You can also calculate co-products and by-products costs and the impact of waste.

Read how Boyum BEAS for SAP Business One for life sciences has helped Lancasco know the costs of production orders in real-time.

Corporación Lancasco was founded in 1927 in Guatemala. As of March 2023, it has operations in Guatemala, Honduras, El Salvador, and Nicaragua. The company is dedicated to the development, manufacture, distribution, import, and export of branded prescription generics and over-the-counter medications. It has an excellent and well-known reputation throughout Central America. The company has partnered with Inforum Guatemala Inc.

The combination of SAP Business One and Beas Manufacturing brought the following results:

• Better control of their costs at a detailed level.
• Improved pricing decisions and competitiveness in the market.
• In terms of quality control, all the processes are already within the system and all the processes and flows have been standardized.