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Material consumption is a critical step of the manufacturing process for regulated industries. From a quality and traceability standpoint, it is important to know the exact quantity consumed from each different batch of ingredients—and from an inventory standpoint—the quantity stocked in warehouses to plan replenishments. Traditionally, enterprise resource planning (ERP) production consumption was done through […]

In pharmaceutical industries, asset management is a core requirement that helps an organization cut costs, increase productivity, and reduce wasted time through efficient and effective maintenance and planning. A critical aspect of asset management in pharma and biotech is the traceability and the recording of asset maintenance activities for regulatory purposes. During routine Food and […]

Stability studies apply in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. These studies are essential for pharmaceutical products as they ensure product quality, safety, and efficacy throughout shelf life. It is crucial for the pharmaceutical industry to evaluate the durability of products before and […]

Process tolerance in regulated industries, such as pharmaceutical and biotechnology, is extremely strict. Weighing and dispensing is a critical part of a complex manufacturing process because it can heavily influence the quality of the final product. The weighed quantity must comply with a predefined process tolerance. Equipment used to weigh such quantities must be qualified […]

One of the biggest challenges for the life sciences industry is to ensure efficiency and control both through the supply chain and across the complex operational landscape—all while complying with regulations. Calculating the clinical supply-demand, optimizing the production, and managing the logistical requirements of moving clinical products are crucial aspects for pharma companies. Moreover, effective […]

Labeling plays a critical role in the pharmaceutical manufacturing process because labels act as unique identifiers for the material that is transacted during inventory operations. It is fundamental that all the information is printed clearly and precisely to ensure compliance and full supply chain traceability. All the relevant information for printing should be centralized—avoiding parallel […]

Even though life sciences organizations like pharmaceutical companies and medical devices manufacturers have undoubtedly heard about the cloud, migrating to it from on-premise technology is easier said than done, especially when that technology has kept the organization running and secure for 10+ years. But as technology evolves, life sciences organizations will soon no longer have […]

When it comes to weighing and dispensing material in pharmaceutical industries, the precision and accuracy of the measurements are crucial as the required quantity of materials is calculated proportionally in the formulas. The scale sensibility and its calibration, among other factors, can introduce errors during the measurement. Errors are not entirely avoidable because they are […]

If you are a life sciences organization in Pharma, Biotech, Medical Devices, or Clinical Trials/Supplies—you must identify and track each container of GMP-critical materials. While Microsoft Dynamics 365 Finance and Supply Chain Management does let you manage and track batch numbers and serial numbers, it does not map single product units like drums, bags, or […]

According to the FDA guidance prepared under the auspices of the ICH in Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, specifications are important standards that are proposed and justified by manufacturers and sanctioned by regulatory authorities as conditions of approval. The Importance of Drug Specifications […]

As pharma faces increasingly complex compliance standards and fierce competition, many companies are at a crossroads. Technology is driving the industry and while a decade ago the cloud may have been considered risky, quite the opposite is true today. Legacy technology is putting life sciences organizations at risk and holding them back from the efficiencies, […]

As you may know, Microsoft Dynamics AX is approaching end of life leaving life sciences organizations who have relied on Dynamics AX for years with an important decision to make. Continue investing in an unsupported on-premises solution or invest in building a modern cloud infrastructure for the future. There are many factors that will and […]

One of the most common mistakes manufacturing facilities make is not weighing their operations correctly. The first step to avoiding this problem is knowing what you should be doing for each operation, and then following those rules. There are four main ways to weigh your products: Counting pieces Counting by weighing By weight By subtracting […]

What is CSV? Let’s start at the beginning: Computer System Validation (CSV), as defined by the U.S Food and Drug Administration (FDA), is the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that requirements implemented through software can be consistently fulfilled. What is the […]

AX for Pharma, a Microsoft Gold Certified Partner, successfully completes independent audit for the company’s ISO 9001:2015 certification. AX for Pharma, a Microsoft Gold Certified Partner and global systems integrator and ISV, successfully completes independent audit to renew the parent company’s ISO 9001:2015 certification and obtain certification for its North American company. AX for Pharma […]

Weighing and dispensing ingredients accurately and precisely is a critical part of the manufacturing process for regulated industries. An accurate weighing process ensures that manufactured finished products meet all specification requirements since the amount of components consumed in production must comply with the amount in the approved formula. In addition, the dispensing process in such […]

For pharmaceutical and biotech companies, the research and development (R&D) phase is essential for innovation and improvement. This phase is responsible for the discovery, design, manufacture, and testing of pharmaceuticals. As such, this phase involves many experiments and tests, and formula flexibility is key to the process. 1. What is formula flexibility? Formula flexibility is […]

Ease and efficiency are key benefits of a mobile workstation for weighing and dispensing, and installing one is definitely worth the effort as related to meeting the cleaning requirements for good manufacturing practice (GMP) environments. Let’s start at the beginning and cover five steps to streamlining your weighing and dispensing operations: 1. What is a […]

A must: Cleaning in dispensing booths Weighing and dispensing booths are good manufacturing practice (GMP) critical environments as the ingredients used to produce pharmaceutical products are picked up from the containers and poured onto a scale, meaning they are directly exposed to the environment. It is essential to maintain the proper environmental conditions to preserve […]

Improving Quality and enhancing patient safety through implementing a Quality Management System (QMS) helps many Life Science organizations provide high-Quality, patient-centric care. As such, Life Science organizations continue to demand more from their Suppliers with the expectation of being able to audit several elements of their QMS and verify its conformance to ISO 9001:2015 through […]