Issues with data integrity have always existed. With recent egregious cases, the FDA has been taking greater measures to uncover these attempts to misrepresent key data. There have been stories of inspectors looking through the contents of garbage cans to find discarded documentation. Additionally, they are receiving specific training to better identify faulty data.Continue reading "Data Integrity - Being the Trusted Source"
Entries tagged as life-sciences
Merit Solutions' client MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes.
We recently sat down with Van Kwok, Associate Director of MannKind, and asked him to discuss his partnership with Merit Solutions.
First of all, integrated business systems vary widely in cost, with the ones geared for the largest companies in need of near total automation cost as much as 5 times what a comparable system geared for a mid-sized company would need. Secondly, the costs of compliance and costs of non-compliance are only a fraction of value created by integrated business systems. Within or without the pharmaceutical industry integrated business systems pay for themselves by helping cut the costs of production and doing business, e.g. by speeding product cycle time, cutting inventory costs, and more. Third, the disorganization potential of paper-based business systems is far more dangerous to a rapidly growing company. If you feel that you are already awash in paper, you may well be one of those companies that is so consumed in managing paper trails that you cease to see how crippled your operation is. And finally, a host of 3rd parties that can be critical to a mid-sized pharmaceutical firm’s continued success - from FDA inspectors, to Venture Capital sources, to banking institutions, etc.-will look positively on pharmaceutical firms with business systems on par with their scientific expertise.
- Eliminate manual efforts and paperwork, reducing errors and saving time and human tasks
- Audit, capture and store information according to 21 CFR Part 11
- Automatically enforce controls according to SOPs
- Cost effectively and rapidly deploy business systems in a validated manner
- Enforce controls, but with the flexibility to adapt and grow with your changing business over time
Merit Solutions is featured today in the Microsoft Dynamics Partner Community Blog for "Kati Unplugged", a blog series for Microsoft Dynamics Partners by Kati Hvidtfeldt, US Microsoft Dynamics ERP Cloud Lead. In the article, I explain how Merit Solutions was able to help a leading medical services industry player - Innovare Health Advocates - implement a Microsoft Dynamics AX 2012 Life Sciences Cloud ERP Solution that fits their needs and budget like a glove.
You can read the full article here: Kati Unplugged: How Merit Solutions Implemented its Cloud-Based Vertical Solution to Help Position a Client for Growth
- Improve efficiency by removing manual or paper-based processes.
- Adhere to regulatory compliance requirements.
- Forward and backward traceability for all material lot / serial numbers.
- Streamline and automate product traceability processes.
- Improve quality control and customer satisfaction.
- Quickly notify Customers, Vendors, or employees of potential quality incidents.
Learn more about MAXLife Life Sciences software.
We are excited to announce the launch of our new MAXLife ERP Software website! The new site provides a fresh new look and feel meant to enhance the overall user experience. It has been updated with new product information, demos, white papers, and deeper, more content-rich landing pages.MAXLife ERP addresses the industry-specific challenges of Life Sciences companies that produce FDA regulated products. Unlike other ERP systems, MAXLife is an end-to-end solution that addresses a Life Sciences company’s biggest challenge: quality management.
Learn more about MAXLife ERP:
- Electronic Batch Records: Reduce manual processing and operating costs by tracking Batch Records electronically, having them go through a life cycle of approvals, security, and workflows along the way.
- Life Sciences Quality Portal: Manage all of their quality and compliance unstructured documents - such as SOPs, Quality Programs, Training materials, etc... - in a 21 CFR Part 820 compliant environment.
- Materials Control Workbench: Access and view any material lot and / or serial number, the status of that material, and all of the locations of that material - at the click of a button!
- CAPA Incident Management: Streamline and automate Corrective Action Preventive Action (CAPA) incident and non-conformance management processes to correct and prevent issues, measure outcomes, and continuously monitor the system.
- Cost of Quality Management: Track and analyze all costs related to performing quality processes to improve product quality and reduce the cost of quality.
MAXLife Life Sciences Software is based on Microsoft's most advanced and feature-rich ERP system, Microsoft Dynamics AX. Gartner, Inc. has named Microsoft Dynamics AX a “Leader” in its ERP Magic Quadrant, and Nucleus Research has found that Microsoft Dynamics AX customers achieve returns in areas of increased visibility, increased productivity, and reduced costs. And with MAXLife Cloud ERP, you can give your employees real-time visibility and anytime, anywhere access to the critical business data they need to be successful - without compromising functionality or security.
MAXLife software increases your visibility into product performance, resulting in better decisions and increased revenues and profits. It enables quality control and quality assurance processes to work together as part of the business system, and to be transparently available for reviewing and reporting. With MAXLife, you can track product quality, proactively see and respond to manufacturing variability, meet GMPs, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.
Many Life Sciences companies we talk to today need to define solid business strategies and goals in order to satisfy investors and secure future funding.
As these companies secure funding and look toward long-term planning, they’ll need access to data to provide business insights and help guide strategy. Therefore, they require an enterprise resource planning solution that goes beyond the basics of planning, budgeting, bookkeeping, and managing cash flow. These organizations need the ability to explore their own data to extract insights for strategic planning and to provide reliable financial forecasts. They require a solution that can extract added value from financial data to help improve decision making and better guide the business.
MAXLife for Microsoft Dynamics AX helps Life Sciences companies meet the needs for early stage funding, while enabling them to position themselves for later-round funding by bringing together people, processes, and technologies to help drive business success:
- Take advantage of new market opportunities or fend off new competitors to gain market share.
- Plan current and future capacity relative to planned growth.
- Quickly analyze all aspects of the business to enable better business decisions in high-risk situations.
With MAXLife for Microsoft Dynamics AX, Life Sciences companies have access to accurate, real-time information about product costs, sales trends, and profit margins. This enables more informed strategic decisions about where to spend money, how to grow revenue, and how to strengthen margins.And with MAXLife Cloud ERP, you can give your employees real-time visibility and anytime, anywhere access to the critical business data they need to be successful - without compromising functionality or security.
After spending more than 10 years working with the smallest medical device manufacturers to larger pharmaceutical organizations, we understand the unique needs of the Life Sciences Industry. For that reason, Merit Solutions developed MAXLife ERP - to help our clients overcome the business challenges of today while building and remaining flexible for what the future brings.
Take advantage of a fully integrated Quality Management system that enables you to improve product quality and safety, reduce organizational risk, and increase customer satisfaction.
- Cradle to Grave Lot Traceability
- Corrective Action Preventive Action (CAPA)
- Cost of Quality Management
Enjoy extended Compliance Management features that support FDA requirements (including 21 CFR Part 11), Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs).
- Controlled Documents Management
- Audit Trails / Electronic Signatures
- ePedigree Tracking and Management
Learn more about Merit Solutions Life Sciences ERP Software, named one of the Top 15 Add-ons for Microsoft Dynamics AX by the site DynamicsWorld.