Merit Solutions, a leading provider of Microsoft Dynamics AX Life Sciences software solutions, is proud to announce today that MAXLife for Microsoft Dynamics AX has passed the Software Solution Test for Microsoft Dynamics, which is a major requirement for Certified for Microsoft Dynamics® status. For medium enterprise and large global life sciences companies, MAXLife for Microsoft Dynamics AX provides a complete, enterprise wide business software solution designed to help organizations gain insights and increase performance. MAXLife enables life sciences organizations to connect with their business partners and customers, optimize business processes, and gain competitive advantages, while simplifying compliance processes mandated by the FDA, customers, and other regulatory agencies.

Certified for Microsoft Dynamics is Microsoft Corp.’s highest standard for partner-developed software. This certification represents a significant step in elevating the standard for partner-developed software solutions for industry-specific business applications. Solutions with a successful software test have demonstrated development quality and compatibility with the Microsoft Dynamics product. VeriTest, a service of Lionbridge, performed independent and rigorous testing on the solution’s integration with Microsoft Dynamics AX. Merit Solutions has also earned the Microsoft Certified Partner designation with the ISV Competency.

“By requiring the software solution to meet our highest standards, Microsoft is assuring customers that these certified solutions work with their investments in Microsoft Dynamics,” said Doug Kennedy, vice president, Microsoft Dynamics Partners. “Microsoft congratulates Merit Solutions on the software test results and wishes it success in earning the Certified for Microsoft Dynamics designation.”

Built on the .Net architecture of Microsoft Dynamics AX and Microsoft SharePoint, MAXLife software increases your visibility into product performance, resulting in better decisions and increased revenues and profits. The software 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 for Microsoft Dynamics AX, you can track product quality, proactively see and respond to manufacturing variability, meet GxP, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

“Merit Solutions has always been committed to software excellence, and passing the Software Solution Test for Microsoft Dynamics is a reflection of that commitment,” said Bill Burke, President, Merit Solutions. “This milestone also validates our dedication to providing Life Sciences companies with the highest quality software solutions based on the full Microsoft stack.”

About MAXLife for Microsoft Dynamics AX 

Unlike Oracle or SAP, MAXLife for Microsoft Dynamics AX fits with Life Sciences organizations’ existing Microsoft systems, is more familiar to use and easier to deploy, and has a lower total cost of ownership. MAXLife extends the already strong core Microsoft Dynamics AX to meet specific requirements for Life Sciences companies, including: Increased Materials Management, Control, and Traceability, CAPA Tracking and Resolution, SharePoint Part 11 Document Management and Control, Electronic Signatures, Contracts / Charge backs, ePedigree Tracking for Distribution Compliance, 21 CFR Part 11 Compliance, 21 CFR Part 820 Quality Management Compliance, and Cost of Quality Insight and Management.

About Merit Solutions, Inc. 

Merit Solutions is a leading Microsoft Dynamics business consulting and software development firm helping clients plan their technology investments, design solutions, and implement projects that improve business performance and drive a competitive advantage. We deliver end-to-end solutions that enable our clients to streamline processes, reduce costs, and facilitate business growth.

Merit Solutions is a Microsoft Gold Enterprise Resource Planning Certified Partner, a Microsoft Dynamics President Club member, AMR Research Certified in Process Manufacturing for Microsoft Dynamics AX, and has been recognized as a Microsoft Excellence Partner for working successfully and collaboratively with customers and partners across the world. www.meritsolutions.com

MAXLife for Microsoft Dynamics AX enables these companies to take a proactive approach to improve compliance and product safety.

Built on the .Net architecture of Microsoft Dynamics AX and Microsoft SharePoint, MAXLife software increases your visibility into product performance, resulting in better decisions and increased revenues and profits. The software 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.

MAXLife for Microsoft Dynamics AX helps Life Sciences organizations with:

• Part 11 Document Management
• ePedigree Tracking
• CAPA Resolution / Incident Tracking
• Product Quality Management
• Electronic Signatures
• Cost of Quality Management
• Lot Track and Trace Management
• Complaint Resolution / Management
• Access Control
• Process Control
• Risk Management

With MAXLife for Microsoft Dynamics AX, you can track product quality, proactively see and respond to manufacturing variability, meet GxP, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

Learn more:
Microsoft Dynamics AX Life Sciences

The way regulatory information is managed and used in pharmaceutical organizations today is far from optimum, posing a business risk of losing valuable insights and missing out on commercial advantages. To turn this situation around, life sciences organisations need to take a more strategic approach to how they manage the critical regulatory information that lies within their systems.

There is no doubt that regulatory compliance – whether relating to product information management (PIM) requirements, pharmacovigilance, or meeting new health authority submissions standards (especially around eCTD) – poses a significant challenge to life sciences organisations today, Equally, though, companies must respond to intensifying competition, pursue new markets and support growing merger and acquisition activity, for example.

Read More:
Regulatory Regime: A Burden of Chance for Knowledge?

Compliance to 21 CFR Part 11 may seem daunting. Although many solutions claim 21 CFR Part 11 compliance, the cost of these systems is often prohibitive for all but the largest life sciences organizations. At the same time, many solutions are difficult to deploy and even harder to use, which further limits their ability to create compliant-environments quickly and effectively.

Fortunately, MAXLife helps Life Sciences companies comply to 21 CFR Part 11 without added complexity.

For companies who need to track unstructured data - such as work instructions, specifications documents and standard operating procedures - in accordance with 21 CFR Part 11 regulations, Merit Solutions has extended the capabilities of Microsoft SharePoint for use as a document management and quality control solution. These Life Sciences companies can now simplify compliance by utilizing the capabilities of Microsoft SharePoint for complete document lifecycle capabilities, including automated workflows, audit trails, and full versioning support.

For more information on using Microsoft SharePoint for 21 CFR Part 11 compliance, please contact us today.

Developing such functionality from scratch was a daunting proposition. It would take time and resources while delaying development of novel treatments for debilitating diseases and disorders.

Researchers at Microsoft Research had a solution. Their new, open-source library of bioinformatics functions, the Microsoft Biology Foundation (MBF), part of the Microsoft Biology Initiative, was designed to address just such a challenge. When the J&J PRD researchers learned about this, they immediately became intrigued.

Read More:
Using Software to Enhance Healthcare

The State Food and Drug Administration is circulating a draft regulation that would improve traceability–among the country’s greatest pharma weaknesses–and expand supply chain auditing for APIs, excipients and packaging, reports International Pharmaceutical Quality. The draft shows intent to align with the drug master file system in the U.S. and Europe.

SFDA emphasizes that “at present, China does not have the information and relevant information platform linking the APIs and pharmaceutical auxiliary materials” to the drug products in which they are used. The new system is designed to “help trace the sources and enhance the efficiency of supervision and administration.”

SFDA also clarifies that the proposed regulation applies only to APIs and pharmaceutical auxiliary materials that will be used in drug products that are registered in China.

Read More:
China’s SFDA Moving Toward Expanding Supply Chain Auditing and Filing Requirements

“We were working to squeeze every last bit of efficiency out of safe, but outdated, technology,” Health and Human Services Secretary Kathleen Sebelius said Thursday. “It was like a car that you got tuned up but it still didn’t accelerate fast enough when we needed it to.”

Most notably, government researchers still used chicken eggs to grow vaccines, a process that dates back to the 1950s and can take up to several weeks to produce results, she said.

“Even if you yell at the eggs, they really don’t grow a virus in a faster method,” Sebelius joked, referring to an egg’s ability to grow a vaccine.

Successful countermeasure development also has proven difficult because the private sector saw little financial benefit in producing biodefense medicines and vaccines for the government, according to Sebelius. The development process can be costly and there is little if any market for such products outside the public sector.

Read the full report:
Biodefense System Overhaul Was Necessary, HHS Secretary Says

Among the greatest similarities is the loss of experience. High-priced lifers in operations–those with decades of experience on equipment still in use–were replaced with lower cost contractors and newbies, and sometimes not replaced at all. At higher levels, spreadsheet-toting MBAs took over from through-the-ranks management.

Among the greatest differences between the telecom and pharma layoff situations: customers don’t metabolize telecom products. Interruptions to “adult entertainment”–the chief consumer of the rapidly multiplying bandwidth that telecom companies were then making available–had a consequence far less severe than drug-supply and pharma-quality interruptions.

Read the full article:
Spare Pharma the Dot-Com Cleaver

One of this year’s group runs a large cancer drug business. One not only founds biotech companies, she also places some savvy venture bets on future stars. Several are CEOs pursuing excellent science and top clinical trial prospects. Some came up through the scientific ranks, others through the business development side of the business.

In an entrepreneurial business like biotech, results are all that matter. So in some respects it’s the ideal climate for women who want to reach the top ranks, where the old boy network helps but certainly doesn’t rule. And as more women break into these ranks in the years to come, as is certain to happen, this group will become even harder to narrow down to a top 10.

Read More:
Top 10 Women in Biotech