Even with the best design and steadfast controls, sometimes things go wrong. Deciding on a risk profile and executing the appropriate action may be interpretive. Manufacturers have the hurdle of coming to an agreement with the FDA. Inevitably, they don’t always agree. An attempt was made last year to bridge the divide by creating a working group consisting of manufacturers, the FDA and representatives of a nonprofit group representing healthcare technology professionals. This group seeks to create a consistent means to evaluate risk between regulators and manufacturers. They will provide feedback to the FDA on specific areas where better guidance would be beneficial.Continue reading "FDA and Industry- Bridging the Risk Management Gap"
Entries tagged as life-sciences
Enterprise mobility has a transformative role to play in every industry. The field of life sciences is no exception. Implementing appropriate mobile technologies enables life science firms as well as healthcare practitioners to deliver the best patient outcomes to consumers. There are so many kinds of mobile technologies, though – which ones will be of greatest use?Continue reading "Enterprise Mobility: A Natural Fit for Life Sciences"
In today’s technology obsessed world, even the delivery of healthcare is dependent on software driven devices. Some are standalone, others are networked together. With the ever growing web of connectivity and the movement towards personal medical care, security issues predictably arise. Hacking has become so common place, we are no longer surprised when it happens. Losing your credit card information is bad enough but what if a wearable device was compromised by an anonymous cyber criminal? Remember, the motivation for someone to control another individual’s pacemaker or insulin pump is irrelevant, the point is that if something can be hacked, someone will find away to do it. Hackers may use these devices as another means to troll for personal information.Continue reading "Medical Device Security-Beyond a Data Breach"
Merit Solutions and OnShore Technology Group are excited to launch a new monthly Life Sciences Executive Webinar Series titled "Mastering Compliance and Innovation”. This series will identify ways Life Sciences organizations can excel beyond the basics and leverage innovative technologies to achieve continuous improvement and global success.Continue reading "Life Sciences Executive Webinar Series - "Mastering Compliance and Innovation""
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"
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.