When a company is considering replacing their existing or acquiring a new ERP system there is part of the entire process that sometimes is left out or left to chance: business process improvements and business process management.
This is really a crucial part of any successful ERP implementation.
What are Business Process Improvement (BPI) and Business Process Management (BPM)? How are they different? How are they similar? What are the challenges and best practices with BPI and BPM? And why are they important to a global enterprise ERP implementation?
The purpose of this document is to outline the challenges and best practices associated with BPI and BPM initiatives - and how they related to new global ERP investments.
Read the white paper by Jack Toland, Senior Consultant at Merit Solutions: Business Process Improvement (BPI), Business Process Management (BPM), and How They Relate to New ERP Implementations
E-Health services and wireless, wearable devices are spawning new products regularly. Last year monitoring devices grossed $2.9 million and is expected to grow to $17.1 million over the next five years. There is increasing demand for expanding the old point of care paradigm from the traditional hospital/doctor’s office setting to a more mobile medical environment. With this expansion, come new challenges with compatibility, wireless performance, security and compliance with the somewhat fledgling regulations.
Continue reading "E-Health Services: The New Boon"
Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement. Only voluntary recalls are in scope and whether they are performed by the manufacturer or at the request of the FDA is irrelevant. The difference is important as a recall requires the submission of a correction and removal report to the FDA. These reports become part of public record and thus may not put the company in a positive light. What may be considered recalls can include updates to instructions or changes to components or labeling.
Continue reading "Recalling the Difference"
With increased scrutiny on the supply chain and rising complexities, finding a dependable manufacturing partner is critical. Outsourcing to a contract manufacturer may seem like an easy thing to do if your company does not have the expertise, equipment or capacity to manufacture a product. You turn to a distant family member to fill in the gaps and move on to something else. However, if not sufficiently evaluated or controlled, the solution becomes the crazy aunt you wish would go away. Ultimately, the sponsor company is accountable to ensure that the contract manufacturer is compliant with cGMP and applicable Quality System Regulations.
Continue reading "Choosing a Contract Manufacturer- It's All in the Family"
Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door - or even defective product reaching the customer.
Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.
Continue reading "Device Design Transfer - A Smooth Hand-off"
A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would be considered to obstruct an FDA inspection and potentially lead to a supposition of adulteration. Last month, the final guidance was issued. The document attempts to define what behaviors are considered to mean an intentional delay or refusal. The FDA has the authority to enter any facility under the jurisdiction of the FD&C Act at reasonable times and conduct inspections.
Continue reading "Not Obstructing the FDA - Be Reasonable"
The purpose of MDR reporting is to provide a means to collect data that may indicate the presence of a safety problem. MDR reporting can be confusing and it is certainly an area where mistakes are abundant. Some mistakes however will garner more scrutiny from the FDA. In extreme instances incorrect reporting or lack of appropriate reporting can lead to criminal charges.
Continue reading "MDR Perils –Avoiding Entanglement"
When questioned if their company has a focus on quality, most managers and employees will say yes. This might be because at a minimum, it is the right thing to say. They may also believe that since they have some procedures or a quality policy that this suffices and that quality practices will just fall in to line. Under further scrutiny, however the differences between perception and reality become apparent.
The view from higher levels in the company may be that it has a well disseminated quality culture. But as you travel down the organization chart, the response may not be so positive. A culture of quality is a full time commitment to quality. It is not just referencing standards in a few SOPs. Everyone should understand who the customer is and what they expect.
Continue reading "Building a Culture of Quality- More Than Words Can Say"
Supply Chains have never been more dynamic than they are today. Their complexity has increased leading to risks associated with geography, compliance - even natural disasters. This occurs on the vendor and the customer side. It follows that as complexity increases, so do costs. When these risks are not appropriately managed companies can lose customers, profits and reputation.
Supply chains have gone global for a number of reasons. They may be seeking cost savings or they have capacity issues. Companies may outsource certain tasks seeking subject matter expertise or to allow themselves the ability to focus on core capabilities. Whatever the motivation there are times when it seems like the sky is falling but there are some best practices for supply chain risk management that can reduce the company’s vulnerability.
Continue reading "Supply Chain Risk Management"
The goal of each medical device manufacturer is to produce safe and effective products. These manufacturers are responsible for carrying out postmarket surveillance activities to monitor and collect the performance of their products. In the current regulatory environment, companies are under scrutiny for their complaint procedures and their ability to react and respond.
The FDA annually receives hundreds of thousands of medical device reports of serious harm, deaths or malfunctions. These are not only from the manufacturers but also the end users. The regulation provides a means for the FDA to monitor significant issues regarding medical devices.
Continue reading "Medical Device Reporting - Getting it Right"