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S&OP Doesn’t Have to be Complex

Many of us think of S&OP and think of days in meetings and unending discussions between the functional groups in the business. Many will agree it is a powerful tool. Many will also contend the benefits might not justify the tremendous cost of the exercise. Others might also look at expensive software for sale at high prices that could simplify the process but still would not yield the necessary benefit.

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E-Health Services: The New Boon

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.

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Your Distribution ERP Should be Tracking These Metrics

There are hundreds of possible metrics in the textbooks that your distribution operations could track. Having a grasp of each metric can provide some sort of value to the company. But there are a few that are critical to your business performance and goals. Those few are known as key performance indicators (KPIs). They need to relate to your goals, they should be available automatically from your ERP as transactions complete. Everyone should know how the metric is calculated and how their jobs affect those metrics.

Here are a few I like.

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Recalling the Difference

Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement.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.

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Maintain Your ERP System Efficiently

Your ERP is a powerful tool. You need to keep it sharp or the performance will drop away and if it really gets bad, you will have to replace the tool.

Here are some tips to keep your tool sharp. I will write these as annual events, but your maintenance might be more or less frequent.

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Choosing a Contract Manufacturer- It's All in the Family

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.

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Your Decision Making Tool is Your ERP System

Decision making requires that we recognize a need, analyze appropriate data, and select the best alternative and take the right action. There is psychology in action here. The right action for one business will be the wrong action elsewhere. The people who will need to take action must be comfortable taking suggestions from a machine. They also must be confident that the rules we set up in the machine are almost always the right action to take. And users should understand where the suggestion might not be best.

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Device Design Transfer - A Smooth Hand-off

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.

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Not Obstructing the FDA - Be Reasonable

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.

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Use Your ERP to Achieve Supply Chain Resilience

When the demands to a supply chain are smooth and predictable and the supply always matches the demand perfectly we can all live the life of Riley. Who is ready to take off work early this afternoon?

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