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  • Advice You - Tips for Maintaining the Integrity of Important Files in a Modern Workplace

    One day at the office I was taken quite aback when I attempted to open an Excel spreadsheet I'd created and was prompted with the message: File in Use
    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
    . Open as a read-only file? File in use? What was that all about? It was, after all, my file. Who else would be using it?

    The answer to that la
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t question was, of course, anyone. Anyone at all could be using it. I worked in a company with 200+ employees and most of our documents were saved on d
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rives with shared access. My file, essentially, was available to anyone in the entire company, from upper management to the receptionist, on a whim.

    Wi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    h large network systems and often multiple branches, many companies these days have shared drives where employees in different regions can access the sam
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e files. Often, those companies limit the size of the hard drives on individual computers to minimize the saving of files onto the computer itself, forc
    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
    ng employees to store their important files where all can see.

    Some files, by nature, need to be shared. Often spreadsheets and other documents are pas
    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
    sed from person to person and department to department via shared drives such as my company used, or via email. Still, other files are meant to be priva
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e records, not available to all eyes. Either way, you'll want to ensure the integrity of your important documents.

    There are a number of ways to protec
    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
    t important files. Here are some suggestions to get you started:

    -- For files that are intended for your eyes only, add a password. Most commercial so
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    tware such as Excel and Word offer the option to password protect your document. Consult your software manual or the help file for further information.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Be sure to choose a secure password and don't share it. Bad choices for passwords include your birthday, spouse's name or child's name. Good choices i
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    nclude both letters and numbers. Don't hesitate to change passwords often.

    -- For files that others need to see, some commercial software will allow yo
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    to add a password for those making changes. Others will be able to open the document as a read-only file. They can look, but they can't touch!

    -- For
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    files that others need to see and perhaps even touch, make a backup and password protect that one. Better yet, put it on disk and keep it in a safe pla
    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
    e. Just remember to update both copies when you make changes to the document.

    -- Check with your company to see if there are secure drives. Some compa
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nies, such as the one I worked for, have drives that have private access. Documents are stored on a shared server but viewing is restricted to the same
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ogin as the person who created the document.

    -- Don't hesitate to ask your company's IT department about other options. That's what they're there for.
    .

    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

    Though it is normally a practice for all records in a company to be backed up on a regular basis, it's also sometimes a rather large production for IT t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    retrieve one small document off of those backups. So be responsible for the integrity of your own files. It may save you a whole lot of grief one day


    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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