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 […]