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All Blog Posts (1,023)

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

Four years of the EU’s Cosmetics Product Regulation

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Added by John Robinson on June 2, 2017 at 6:18am — No Comments

Understanding steam sterilization microbiology

Steam sterilization is an important means of killing microorganisms in microbiology. Sterilization is the method of removing all viable organisms from a source in a defined environment. Microorganisms are said to be dead when they are rendered ineffective by a decrease in their population in an environment. When they are unable to grow within their environment; they are…

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Added by Compliance4all on June 2, 2017 at 6:06am — No Comments

Stark Law considerations for structuring and auditing medical director and administrative agreements

When structuring and auditing medical director and administrative agreements; the provisions of the Stark Law need to be taken into careful and full consideration. This is because the Stark Law is the operative law for this kind of arrangement.

Implementation of best practices for negotiating and drafting administrative arrangements on behalf of health systems, hospitals, medical groups and…

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Added by Roger Steven on May 30, 2017 at 7:27am — No Comments

Implementing the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The FDA’s Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food, which was passed on April 6, 2016, has now become final. This is the latest in a series of as many as seven rules that have been getting legislated from January 2013 with the intention of creating a modern, risk-based framework that ensures food…

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Added by Compliance4all on May 30, 2017 at 5:54am — No Comments

Clarifying the misconceptions about DMFs and Quality Agreements

A Drug Master File (DMF) is a file that lists the materials and processes that have gone into a drug. This submission is made by manufacturers of drugs to the FDA, and has to contain everything that goes into the drug, and has to include not only the materials and the processes; but also confidential information pertaining to the facilities in which the drugs are manufactured. All the inputs that have gone into not just the manufacturing, but also the packaging and storing…

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Added by Compliance4all on May 29, 2017 at 6:13am — No Comments

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