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As more Life Sciences companies view CDMOs as strategic innovation partners, CDMOs must learn what it takes to fully capitalize on the opportunities. Thanks to the burgeoning demand for Advanced Therapy Medicinal Products (ATMP) and the recent rapid delivery of mRNA vaccines, the global Contract Development and Manufacturing Organization (CDMO) market is growing at a […]

What Batch Number Compliance means in the Pharmaceutical industry All companies operating in the Life Sciences industry must comply with current regulations (e.g. US FDA) and guidelines (e.g. cGMP). Regulations require materials to be uniquely identified and their production history to be traceable at any point in time. A batch (also called “lot”) is a […]

Gain control over your most important outsourcing activities with an easy-to-implement, configurable Life Sciences ERP solution native to Microsoft Dynamics 365. Thousands of small companies drive a significant percentage of Life Sciences innovation. Armed with patented science and small management teams, these companies outsource operational tasks to prove the viability of new therapeutics and accelerate […]

As M&A activity in the pharmaceutical and Life Sciences sector picks up in 2023, you’ll want to add value and flexibility with an affordable ERP system that accommodates the industry’s unique regulatory requirements. After a challenging year for mergers and acquisitions (M&A) in the Pharmaceutical and Life Sciences sector, analysts at PwC are expecting deal […]

To-Increase, a leading global Independent Software Vendor (“ISV”) for Microsoft Dynamics 365 (“D365”) SaaS business applications, today announced the acquisition of AX for Pharma, another fast-growing Microsoft Dynamics 365 ISV and integrator focused exclusively on SaaS business applications for the pharmaceutical, biotech and medical device industries. The financial details of the acquisition are not disclosed, and the transaction is subject to clearance from the Italian Prime Minister’s office.

Pharmaceutical companies, Biotech firms, and other Life Sciences organizations are all too familiar with the term Computer System Validation (CSV). It’s an important regulatory requirement that helps ensure product quality and patient safety. As businesses in the Life Sciences sector increasingly go digital and eliminate paper-based processes, adhering to CSV requirements set forth by the […]

Modern data management, through a fully compliant Enterprise Resource Planning (ERP) system, can help life sciences organizations comply with regulations and follow current Good Manufacturing Practices for the benefit of all. Complexity in drug manufacturing is on the rise, and so is risk. New gene- and cellular-based advanced medical therapies, for example, require specialized handling […]

ERP Systems for Life Sciences: How to Choose the Right One Life Sciences organizations need ERP systems with industry-specific capabilities to ensure regulatory compliance and automate business processes. This blog explains the best way to get what you need. A patchwork of legacy systems, exacerbated by extensive merger and acquisition activities over the years, has […]

When it comes to product management and development, life sciences companies face significant challenges. There’s the constant pressure to accelerate manufacturing capabilities, reduce the time-to-market, and cut costs – all while complying with increasingly complex regulations. How do you address these challenges, though? How do you continue to develop, manufacture, and distribute critical products without […]

To better support pharmaceutical companies, biotech firms, and medical device manufacturers in Australia, AX for Pharma will be expanding its presence in the region with an office in Sydney. “With its wide range of startups, mature companies, and mergers and acquisitions, Australia is a promising market for us,” says Andrea Ruosi, CEO and Founder of […]

Move Your ERP to the Cloud for Greater Agility, Security, and Compliance Managing a global Life Sciences enterprise is easier when your employees can access the tools they need from anywhere, on any device. Enterprise organizations have generally been reluctant to move their enterprise resource planning (ERP) systems into the cloud. After all, it’s a […]

2023 New Year’s Resolutions for Life Sciences Companies Make this the year you minimize your supply chain risk, address increased complexity, and form strategic partnerships for efficient digital transformation. Back in the spring of 2022, Contract Pharma asked pharmaceutical services thought leaders to “offer insight on key trends influencing the market.” We came across this […]

Since most ERPs aren’t developed for Life Sciences, Pharmaceutical companies have limited options. Like all large organizations, multi-national Pharmaceutical companies, Biotech firms, and Medical Device manufacturers need an enterprise resource planning (ERP) system to automate and optimize key business processes. General ERPs, however, fail to account for the specific compliance and risk mitigation needs of […]

While ERP migrations can be expensive and time-consuming, relying on an unsupported solution can put your GMP business at serious risk Support for Microsoft Dynamics AX 2012 ended on April 12, 2022, so if you haven’t already upgraded to Microsoft Dynamics 365 the time to do so is now. While ERP migrations can be expensive […]

Pharmaceutical and biotech companies need to track each single product unit and this has been a consistent problem when implementing ERP systems. For instance, standard Microsoft Dynamics 365 for Finance and Operations (D365) can manage and track material at batch level only. In situations where the management of single product units is critical, AX for […]

The pharmaceutical industry is experiencing a paradox between growth in scientific progress and actual innovation output. On one hand, the pharmaceutical, biotech, and medical device industries have been staggering growth over the last few decades: Pharma companies spend 17% on their research and development (R&D), which is expected to reach $203 billion by 2024. But […]

Life Sciences companies are subject to Good Manufacturing Practices (GMP) guidelines and country-specific regulations, such as those issued by the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. As a result, in regulated industries, the vendor selection process is made with a great deal of scrutiny. […]

In the pharmaceutical and biotech industries, it is crucial to store temperature-sensitive raw materials, active ingredients, and products in temperature-controlled areas such as cold rooms, refrigerators, or freezers. Therefore, it is necessary for any enterprise resource planning (ERP) system to create and control variables such as temperature and humidity. Additionally, Life Sciences companies must ensure […]

In the pharmaceutical industry, precision and accuracy are critical. To ensure that the finished product meets the highest quality and safety standards, you must meticulously and efficiently weigh and track each component or item. Commonly, the counting process is carried out by visual inspection or manually counting individual units. When small-size items such as tablets […]

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 […]

Computer System Validation, or “CSV”, is a process of testing and qualifying a computerized system to ensure that it works as intended in a consistent and reproducible manner that is as safe, secure, and reliable. CSV is a top priority for pharmaceutical, biotech, and medical device companies, which must show that all computer systems can […]

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 […]