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When you consider the relationship a life science company shares with the FDA it’s easy to visualize the love/hate kinship of a parent and child. It’s also simple to deduce who the parent might be. After all, the FDA Mama or Papa Bear has never been shy when it comes to playing by regulatory rules.

The Goals of Life Science and the Goals of the FDA: Mutually Compatible or Mutually Exclusive?

The goals of a life science company are likely to include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, etc. The goals of the FDA include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals is noble and in theory supports the goals of the other. In practice however, the goals of these separate institutions seem almost mutually exclusive.

Change Control Software: Middle Ground for Two Separate Powers

Like most solutions to apparently irreparable problems, the solution that allows both life science companies and the FDA to find a cheerful middle ground is the solution that benefits both organizations. This solution includes the implementation and use of change control software. Change control software is valuable for the simple reason that it allows life science companies to artfully manage (without spending ridiculous man-hours) those changes that occur at any stage of a product’s development or manufacturing processes. Documentation, routing, tasks and employee accountability are also concerted via a solid change control software solution.

The benefits of a change control software solution are many but to truly understand these benefits it’s beneficial to first understand the problems that often maintain many life science professionals in a state of “regulated” frustration.

The Problems

Among the problems that lie within the walls of many life science companies is the problem of change management processes that are controlled

1) manually or

2) with a hybrid/decentralized solution.

Most companies simply want to save their hard earned ROI, but when considered carefully it’s easy to see that manual and/or hybrid solutions won’t save companies money in the long run, and in addition, present a variety of problems that might have managed to stump even Solomon the wise.

Manual and Hybrid Solutions: Problems that Contribute to Greater Problems

Listed below are some of the problems that life science companies can avoid with a digitized and centralized change control software solution.

High Costs-

Life science professionals may think they save money with a paper-based system but in all reality they spend a great deal to pay for the tedious man-hours spent on the manual routing of documents, the document approval process and on manual search and document retrieval (if the document can actually be found). A change control software solution however manages to automatically route documents, seek the appropriate approvals/electronic signatures, search for documents and retrieve them.

Validation Procedures-

The FDA requires that processes (this includes change processes) be validated. If a life science company has to validate their processes manually it can be a far greater challenge than some companies care to undertake. Electronic validation presents a far more effective alternative that saves time, money, and effort. In the long run, manual validation can also cost more than a centralized solution. When searching for change control software, ask the software sellers if automated validation services are available.

No Centralized Location-

A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one digitized and centralized location. A commendable change control software solution digitizes and centralizes information so that life science associates can find the organized information they need-when they need it. A good change control software solution will also manage almost any type of file required throughout any of the GxP processes.

Document Revision Processes-

When change inevitably occurs the manual document revision process can be faulty in the extreme. Life science employees will unfortunately be subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change control software solution however can provide revision control that is automatic and centralized so that once submitted, documents can be routed and approved quickly and effectually. Change tracking will also be automatic.

Also, when searching for the change control solution that will fit the needs of a life science company, professionals should look for a solution that is

1) customizable to their needs and that

2) require form explanations for changes that are being made. Accountability, after all should be an important aspect of change control.

A Picnic in the Park

Change control can take life science professionals one step further to a change management process that could potentially be compared to a picnic in the park.

Marci Crane is a copywriter for MasterControl in Salt Lake City, UT. For more information in regards to change management software or change control software, please feel free to contact a MasterControl representative

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Accounting is defined as “the art of recording, classifying and summarizing in terms of money transactions and events of financial character and interpreting the results thereof.” In simplest words, we can say:

(1) Accounting is an art

(2) of recording classifying and summarizing

(3) in terms of money

(4) transactions and events of financial nature and

(5) interpreting the results thereof

Accounting is an art of correctly recording the day to day business transactions: It is a science of keeping the business records in a regular and most systematic manner so as to know the business results with minimum trouble. Therefore, it is said to be a statistical procedure for the collection, classification and summarization of financial information.

Objectives of Accounting

The objectives of accounting are two-fold:

(1) To record permanently, all business transactions, and

(2) To show the effect of each transaction and also the combined effect of all such transactions for a given period so as to find out the profit the business has earned or loss incurred, and also to know the correct financial position on a particular date.

The necessity and importance of accounting can be understood by answering the following questions:

(1) How much we have earned this year ?

(2) How much was earned during the last year ?

(3) Is our business improving?

(4) How much cash do we have?

(5) How much money we owe?

(6) How much others owe to us ?

Accounting Systems

There are various systems of accounting for maintaining business records:

Cash system of accounting

This system records only cash receipts and payments on the assumption that there are no credit transactions. If at all there are any credit transactions, they are not at all recorded until the cash is actually paid or received. Receipts and payments account in case of clubs, societies, hospital, educational institutes, lawyers etc. is the best example of cash system.

Single Entry System

This system ignores the two fold aspect of each transaction as considered in double entry system. Under single entry system, merely personal aspects of transaction i.e. personal accounts are recorded. This method takes no note of the impersonal aspects of the transactions other than cash. It offers no check on the accuracy of the posting and no safeguard against fraud because it does not provide any check over the recording of cash transactions. Therefore, it is called as “imperfect accounting.”

Double Entry System

The double entry system was first evolved by Luca Pacioliin, who was a Franciscan Monk of Italy. With the passage of time, the system has gone through lot of developmental stages. It is the only method fulfilling all the objectives of systematic accounting. It recognizes the two fold aspect of every business transaction.

These questions are of decisive importance for a trader and the answers can only be derived from up to-date financial records. Only the system of keeping the perfect records of all business transactions will help the proprietor to know the amount he has gained or lost.

The main objective of any business is to earn maximum possible profits with minimum expense. In view of this, a commercial organization always tries to expand its business, increase its sales and reduce operating expenses. The progress made in this regard, is always indicated only by the properly maintained financial records.

Meaning of Accounting

In the beginning, the main objective of accounting was to ascertain the result of the business activities (whether profit has been earned or loss has been suffered) during a year and to show the financial position of the business as on a particular date. Accounting has to meet the requirements of taxation authorities; investors, government regulations; management and owners. This has resulted in widening the scope of accounting and may be defined as follows:

“Accounting is the art of recording, classifying and summarizing, in a significant manner and in terms of money transactions and events which are in part at least, of a financial character and interpreting the result thereof.”

Is Accounting a Science or an Art?

In simple words, science establishes relationship of cause and effect whereas the art is the application of knowledge comprising of some accepted theories, principles and rules. Since accounting docs not establish cause and effect relationship it only provides us with the procedure by which objectives of accounting can be achieved, therefore accounting is an art and not a science. Accounting is an art of recording financial transactions in a set of books; classifying in desired categories and summarizing the information for presentation in a suitable manner to the concerned persons for their benefit.

Scope of Accounting

The need of a system of accounting was felt by man early in the history of trade and commerce. The art of book-keeping is as old as the art of trading itself. This art of keeping records passed through many phases since its inception. With the development of commerce, it has attained a position of great importance. Indeed, it can be truly said that accounting has become the foundation on which the whole fabric of modem commerce rests.

Though there is no legal obligation on an ordinary trader to keep the records, every business house finds it essential and convenient to keep the systematic records so as to know where exactly it stands. Moreover, it is legally binding on some forms of business, such as joint stock companies, to prepare periodically, statements in proper forms showing the position of the business. A proper and satisfactory method of accounting is an essential part of any business house for the following reasons :

(1) If no records are kept, it will be difficult to find out accurate net profit. Under such circumstances, tax authorities may overestimate the profits and thus a trader will suffer for not having kept the business records.

(2) In absence of proper business records, the trader will find it difficult to submit the true position to the court in case he becomes insolvent.

(3) Keeping of proper records helps the trader in framing future business plans & policies.

(4) It will be difficult to ascertain and fix the price of business to be sold or disposed off, if no records are kept.

(5) Finally, in spite of the best memory it is beyond the capacity of a trader to remember all the business dealings with back references.

The author is an engineering graduate, B.E.(Hons), and is managing his own software development firm, HiTech Computer Services, that mainly deals in accounting, billing and inventory control software for traders, industries, business houses, hotels, hospitals, medical stores, newspapers, magazines, petrol pumps, automobile dealers, commodity brokers and other business segments, website and web application development for business. The software are available both for intranet and internet. These software are available for download from the website:

Evaluation version download is available at hitech-on-web.com
Copy of the article and full Financial Accounting Primer or Tutorial is available at hitech-on-web.com

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Are you looking for a way to reach a large number of people? Are you trying to share your knowledge with the world? Do you want to increase sales for your business? If you answered yes to any of these questions there are a few things that you can do in order to achieve your goals. But when it comes down to it there are not may options that are better than podcasting. With podcasting you have the ability to get in touch with a wide range of people without having to put out too much time or money. And on top of all of that podcasting is quite fun as well. So why do so many people pass this up?

If you are interested in podcasting you must first know what it is all about. Generally speaking, if you are a podcaster you will pretty much have your own radio show; except in a different format. With podcasting you have the ability to allow people to listen to your broadcast via streaming audio, or they can download it and listen on a mobile device. Either way can work to your advantage.

The biggest benefit of podcasting is that you will have the ability to get in touch with millions of people. Of course, you will have to build up your base of listeners for this to be possible, but all in all if you put the time forth you will be able to reap some rewards in the end. The best way to increase your listener base is to advertise your podcast to people who would be more interested. For instance, if your new podcast is going to concentrate on search engine optimization, get in touch with the people who would be more interested in this. If you already work in this industry chances are that you have some contacts who can serve as your initial base. Then when your podcast becomes more popular it will begin to spread among the industry.

Many people use podcasting as a simple way to relieve stress and have fun. After all, almost everybody has had dreams of being a radio show host. With podcasting you have the ability to do so without much trouble at all. This sure beats having to work your way to the top, and hoping to get a job at a radio station.

Overall, there are many ways that you can use podcasting to your advantage. When it comes down to it the benefits are nearly endless, and regardless of who you are there is a good chance that you can make podcasting suit your needs. So look into what podcasting is all about, and incorporate it into your life.

Leonard Bartholomew, B.S. Computer Science. Internet marketing is a great challenge but it is time to move on. Leonard invites you to find out everything you need to know about podcasting.

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