MedTech I.Q.

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June 2017 Blog Posts (22)

Advantages and disadvantages of Electronic Health Records

Electronic Health Records (EHR) or electronic medical records (EMR), as they are called, are of enormous use in the fields of healthcare and medical sciences. They have a number of features that enable the patient; the medical professional and the healthcare provider have complete and unimaginably easy access to all important records that relate to the patient.

A direct result of the…

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Added by Roger Steven on June 29, 2017 at 7:52am — No Comments

Why does FDA think they can Regulate them, and why do others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their…

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Added by Compliance4all on June 29, 2017 at 5:21am — No Comments

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:15am — No Comments

Documenting Software for FDA Submissions

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The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:15am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

Putting the MS Excel VBA to optimal use

Visual BASIC for Applications (VBA) is the programming language built into MS Excel and other MS programs. It is a macro, which, as we know, is a recording of a series of tasks. At a simple level, it can be thought of as a smaller version of programing in that once certain tasks are assigned to it, it carries them out.

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The main function of a macro is to work within a program such as MS Excel and automate tasks that…

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Added by Compliance4all on June 27, 2017 at 5:36am — No Comments

HIPAA compliance expectations from Small Healthcare Providers

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Added by John Robinson on June 14, 2017 at 6:28am — No Comments

Food safety concerns and issues and ways of mitigating them

Food, despite being the most important human need, is fraught with many risks and hazards. The food chain, which consists of activities that cover everything from the proverbial farm to fork, passes through many points at which a harm of any nature can happen. The chances of risks to the food safety chain are all the more amplified in this age of globalization, when food travels through many regions and continents from its source to its destination.…

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Added by Compliance4all on June 14, 2017 at 6:09am — No Comments

Bringing about positive changes into the US healthcare system

The American healthcare industry is a curious mélange. On the one hand, it is the world’s largest industry, with an estimated size of around $ three trillion. It is a system in which any treatment option that one can think of is available to the patient. Yet, it is characterized by a high degree of inefficiency and exorbitant costs. Many treatment options are out of reach of a large number of patients. It also suffers from non-implementation of many best practices that would have ensured a…

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Added by Roger Steven on June 13, 2017 at 8:21am — No Comments

Change Control is at the core of GMP Compliance

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Added by John Robinson on June 13, 2017 at 6:46am — No Comments

Maximizing profits and patient outcomes in the backdrop of declining reimbursements

In the situation of falling revenues from Medicare billing, many practitioners are worried about the state of their future earnings. A very tangible factor that will help them tide over this problem is often overlooked: the Durable Medical Equipment (DME) program.

The DME program is a very reliable and long term source of income for Medicare practitioners. Yet, this is not considered seriously by most of them because of the various misconceptions that are associated…

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Added by Compliance4all on June 13, 2017 at 5:46am — No Comments

HIPAA implementation for human resources



It is not commonly known that a Covered Entity or its Business Associate have to comply with HIPAA regulations that relate to…

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Added by Roger Steven on June 12, 2017 at 8:31am — No Comments

Learn how to build professional, eye-catching form-driven applications and spreadsheets

MS Excel, a wonder program, has umpteen uses for a number of professionals, students, and a host of other users. We have known for long that it can be used to carry out a number of functions that are varied and interesting. However, adding design elements to MS Excel goes a long way in enhancing its aesthetic appeal, as also the effectiveness.

Booking forms, sales order forms, invoices, loan agreement forms and surveys are just some of the endless kinds of forms…

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Added by Compliance4all on June 12, 2017 at 5:52am — No Comments

An effective internal audit program is indispensable for continuous improvement

Both the ISO and the FDA require an internal audit program of an organization’s Quality Management Systems. This is a core requirement. The simplest way to understand an internal audit system is that it is a tool to assess or inspect an organization’s Quality System.

Apart from helping organizations to fulfill the requirements of auditing set out by the ISO and the FDA…

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Added by Compliance4all on June 9, 2017 at 6:32am — No Comments

Which Excel feature allows you to identify unlocked cells into which data can be entered

Mastering spreadsheet internal controls in MS Excel is a great way to make the most out of MS Excel. Unlocking these internal control features in MS Excel makes the program more efficient and powerful, and helps users derive more value out of its various applications.

Even though professionals in various areas, such as Accountants, CPA's, CFO's, Controllers, Excel users, Income Tax Preparers, Enrolled Agents, Financial Consultants, IT Professionals, auditors, human…

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Added by Compliance4all on June 8, 2017 at 7:10am — No Comments

Quality by Design using Design of Experiments

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Added by John Robinson on June 8, 2017 at 6:48am — No Comments

FDA holds Cosmetic Manufacturers & distributors responsible for the safety and quality of their Cosmetics

Testing cosmetics before the FDA does it is a sound business strategy for cosmetic manufacturers. This is why: Cosmetic manufacturers and distributors are responsible for upholding the quality and safety standards set out by the FDA. This is a legal requirement on the part of players in the cosmetics industry. In order to ensure compliance…

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Added by Compliance4all on June 7, 2017 at 6:11am — No Comments

Writing and implementing effective SOP’s

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Added by John Robinson on June 6, 2017 at 6:36am — No Comments

Challenges to analyzing financial statements

Analysis of financial statements, or Financial Statement Analysis or FSA, as the discipline is called, is the application of one’s analytical ability into understanding the financial statements of a company. This analysis is made to get insights into how the company has been performing financially over a defined period of time. Based on this understanding, financial analysts make forecasts of how the company is expected to perform in the future, based on certain…

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Added by Compliance4all on June 6, 2017 at 6:19am — No Comments

Validation the complies with ICH guidelines



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Added by John Robinson on June 5, 2017 at 7:26am — No Comments

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