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    While installing your new accounting software you have most likely been asked whether you would like to use one of the default charts of accounts included with the program or develop your own. Unless you are very familiar with setting up a set of financial books you will want to choose from one of the selections offered. And even if you have the experience choos
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    ing one of the defaults will save you a great deal of time. But you may ask what if I don’t need all these accounts and how do I know which accounts I should keep. And should I use a numbering system or not? Let me help you by explaining just what a Chart of Accounts is and how to adjust the default list to your needs.

    First of all a Chart of Accounts in its si
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    plest definition is a list of accounts used to track all financial transactions that flow through a business. This list is typically broken in to eight segments: Assets, Liabilities, Equity, Income, Cost of Goods Sold, General and Administrative Expenses, Other Income and Other Expenses. You might see Equity referred to as Capital, Cost of Goods Sold referred to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    as Direct Costs, and General and Administrative Expenses referred to as Expenses. Companies that wish to track Sales Expenses such as commissions, salaries and related expenses of sales personnel and other costs related directly to sales activity might also add a Sales Expense segment.

    The first three segments represent the accounts you will find on a Balance S
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    eet and they will be broken down into sub-segments. Under Assets you will find sub-segments for Current Assets, Fixed Assets and sometimes Other Assets. Current Assets accounts are used for assets that can be readily liquidated into cash, such as cash, investments, accounts and notes receivables, and deposits. You may choose when setting up more than one cash ac
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ount or receivable account to create a further segment. This will allow you to summarize all your cash accounts, for example, on your balance sheet while keeping a separate recording account for each bank account. Fixed Assets accounts are used to record the cost of items purchased that have a useful life that extends beyond one year. The Fixed Assets segment al
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    o includes contra-accounts (reduction of the value of an asset) that are used to record the depreciation of your fixed assets. These contra-accounts are typically named “Allowance for Depreciation – (name of type of fixed asset)”. You should have a fixed asset account and corresponding depreciation account for each type of fixed asset you purchase. Some examples
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    are vehicles, office equipment and furniture, building or leasehold improvements. The Other Assets segment is used for all other types of assets.

    Likewise the Liabilities segment is broken into Current Liabilities and Long-Term Liabilities. Current liabilities represent the company’s liabilities that are to be paid in less than one year. Examples are Accounts P
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    yable, Payroll Tax Liabilities, and Note Payables. Long Term Liabilities represent liabilities that are to be paid over a longer term than one year such as mortgages, vehicles loans and other long term debt.

    The third segment of the balance sheet is the Equity, or Capital, segment. This segment consists of accounts that record the owner’s, partners or sharehold
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    rs investments, draws of profits taken from the company by the investors and the net earnings of the company. For each owner or partner within a business entity there should be an individual investment account and draw account. When a company is incorporated than the capital investment by the shareholders is recorded into capital stock accounts. These accounts m
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    y be broken down further if different types of stock are issued. The Retained Earnings account is used to record the profit, or loss, the company has earned from the beginning of its existence. Usually you will not be posting to this account, as this is the account your software program will use to close out your end of year income statement accounts.

    Moving on
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    to the Income Statement segments, you will want to have in the Income segment accounts to record each type of income you earn in the course of your business. You may want to break out your sales income into more than one account if you have more than one type of service or product. For example if you are a general contractor you may want to track how sales comp
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    re between remodeling and new homes.

    Cost of Goods Sold or Direct Costs are those expenses that relate directly to the sale of a product or service. Again if you are a contractor these typically would include payroll and payroll expenses of your workers, materials, subcontractors, permits, general liability and workman’s compensation insurance, equipment rental
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    , etc. They would not include rent or office supplies.

    General and Administrative Expenses are business expenses incurred that are not dependent on the sale of a product or service. They include rent, phone, office payroll and payroll expenses, employee benefits, office supplies, utilities, etc.

    Other Income typically includes non-sales income such as interest
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    income. Federal and State Income Taxes and any related interest and penalty expenses are what you will find in the Other Expense segment.

    Now that you have an idea of how a Chart of Accounts if typically set up, how do you pick and choose what accounts to keep and which to delete? Print out the default list and go through it choosing the accounts you think you
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    ill need. You will need at least one cash account, an account receivable and accounts payable account. If you do not have employees and don’t ever expect to have any than by all means delete all accounts with payroll in the name. If your company will not be making investments than delete all accounts having to do with investments under Current Assets. You get th
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    picture – however it is easier to keep what you think might be needed sometime in the future. Your program may not let you delete some accounts because they are being used in conjunction with another account or accounts. Let them be. You can also edit account names – as long as the new account name belongs in the same segment as the one you are replacing.

    Now,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    to number or not number. Numbers are used in a Chart of Accounts to sort the accounts correctly. Also, between you and me, accountants are much better at remembering numbers than they are at names so they prefer numbers. When using numbers, each segment is assigned a specific group of numbers. Typically these are as follows:

    Assets – 1,000’s

    Liabilities 2,000’
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de


    Equity 3,000’s

    Income 4,000’s

    Cost of Goods Sold 5,000’s

    General & Administrative 6,000’s

    Other Income 7,000’s

    Other Expense 8,000’s

    When a Sales Expense segment is used it is assigned the 6000 range and each of the remaining segments move up a range. Leave room between sub-segments so you will be able to add if needed. And when setting up numbers within
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    a segment make sure you leave some room between each account as you may also want to add accounts.

    And when in doubt ask a professional. Your software advisor or accountant can get you started in the right direction from the start which may save you a lot of time and aggravation down the road. As with most endeavors, doing it right the first time is always best


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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