It is essential that any FDA-regulated company have an effective CAPA system, but unless they drive the company to a confirmed solution to a quality issue, CAPA systems serve no purpose and they can waste resources. Companies are often at a loss as to what an effective CAPA system should look like, so they err by enforcing either too much control or not enough control.
At its core, an effective CAPA system should be a closed loop system, ensuring evaluation of quality input, implementation of corrective actions and evaluation of the results of the changes.
Continue reading "Understanding CAPA Software"
Yesterday we talked about FDA 483 Warning Letters and CAPA.
Ensuring that your CAPA system meets the FDA requirements can be complex if you rely on guesswork or if you try to memorize all the regulations relating to CAPA that the FDA publishes. Here is a simple 10 step checklist to help ensure that you have covered all the essentials.
Continue reading "10 CAPA Essentials for Passing your Audit"
Executives in Life Sciences organizations that make regulated products have a legal duty to ensure that their company implements whatever measures are necessary to comply with the complex and stringent requirements of the FDA (and other worldwide health organizations) – and they can be held personally liable for failing to conform with regulations.
Two events that keep these executives up at night are upcoming audits and the issuance of 483 observations and warning letter citations. And unfortunately for executives, the FDA has increased the number of warning letters by 625% over the past three years, with 4,882 issued in 2012. (See FDA Inspections, Compliance, Enforcement, and Criminal Investigations for statistics from the past 4 years.)
Continue reading "483 Warning Letters and CAPA"
Merit Solutions was featured yesterday in a spotlight by the Illinois Technology Association (ITA), who noted "this week's Spotlight shines on four great companies & individuals who are revolutionizing industries and changing people's lives by using tech and putting Chicago on the national tech map!"
You can see the full spotlight on the ITA website (ITA Spotlight: Merit Solutions), or you can keep reading below.
Continue reading "Merit Solutions Featured in Illinois Technology Association (ITA) Spotlight"
Merit Solutions has a new opening in the Chicagoland area for a Recruiting and Human Resources Manager.
Manage global recruiting efforts from initial job posting to candidate evaluation and hiring:
- Build strong relationships with existing team members, our customers and external recruitment agencies.
- Research and recommend new sources for active and passive candidate recruiting.
- Manage outsourced immigration processes in North America and Europe.
- Coordinate onboarding of new employees in coordination with internal managers.
- Work closely with management in innovating and administering performance management.
- Lead people-related initiatives globally.
- Develop and manage recruiting and HR process improvement projects.
- Mentor and manage HR resources.
Continue reading "Job Opening: Recruiting and Human Resources Manager".
Tax management is an integral part of an ERP system. Requirements for calculating and reporting taxes differ significantly from country to country. Therefore, the functionality of a tax module in a truly international ERP system must be comprehensive. The tax module in Microsoft Dynamics AX 2012
enables you to define a flexible, multidimensional tax setup by using tax codes, tax groups, and item tax groups. The tax module has been designed with an emphasis on sales taxes, but it can process many other kinds of taxes and duties.
Continue reading "Calculating and Reporting Taxes with Microsoft Dynamics AX 2012"
By now you’ve most likely heard the numerous horror stories of botched ERP implementations and the devastating effects they can have on an organization’s success. Some executives are so terrified of these spooky tales that they remain imprisoned by their out-dated, work-around, and manual business systems and processes.
Business transformations can sound “scary”, but they don’t have to be a nightmare! In fact, they should be rewarding and exciting. Here are ten tips on how you (and your users) can survive the transformation:
Continue reading "Don't Be Scared!"
ERP systems extend into nearly every aspect of a business, and the risk of business disruption related to the ERP system is one that most companies will avoid as long as possible. As a result, many companies delay upgrading their ERP systems longer than they should.
But these companies are ignoring the many opportunities that are available while running on newer releases of an ERP system.
Continue reading "Don't Put Off an ERP Upgrade"
Nothing affects a company’s ability to compete more than the agility of its supply chain, but supply chain agility is dependent on visibility. Supply chain visibility is something that everybody talks about, but they seldom give you concrete information on how to achieve it.
Follow these six actionable steps to increase visibility in your supply chain and you’ll see major improvements in your key metrics.
Continue reading "6 Steps to Improving Supply Chain Visibility"
- Bring customers and suppliers into the forecast process
- Adopt EDI or another rapid communication method
- Open a portal
- Treat outsourced operations like in-house work centers
- Eliminate middlemen and non-value add processes
- Foster a relationship of open partnership
Linda Petta is the Director of Finance for United Way of Greater Cleveland - and she has been a Merit Solutions customer for more than 10 years!
We recently asked Linda some questions regarding her partnership with Merit over the past 10 years. Visit the Linda Petta - United Way of Greater Cleveland page to read what she had to say - and download their Microsoft Dynamics case study.
Then feel free to visit our customer quotes page to see what other companies had to say about their experiences with Merit Solutions.