Life Science Companies, the FDA and Change Management Software

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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Online Political Science Degree - Be A Success - Make A Change

After successfully completing an online political science degree from an accredited university or school, political science majors see world events from various perspectives. There are those who pursue this degree in hopes of launching a political or civil service career. However, there are various other career options.

You can be a high school teacher, college professor, campaign manager, legislative aid, agency specialist, state legislator, district attorney, legislative attorney, consultant, lobbyist, press secretary or even a judge. With these job options, the salary and benefits you can receive is definitely more than sufficient.

Since most voters usually decide at the spur of the moment, political science students learn how to research on context, particularly about different governments which have either failed or thrived in their social agendas. Political Science students concentrate on specific areas of politics such as international relations or the local government.

It is a sad fact that there are politicians who don't really understand minor to major issues which their constituents are facing. To resolve this, they rely on a team of expert consultants and analysts which can fill in gaps for their election platforms. With knowledge on these specializations, students are able to build a track record of research. Later on, they can use these in gaining expertise on their chosen fields.

Whether it's an on-campus or online political science degree program, most universities and colleges encourage their students to participate in their specific department. They require their students to complete short certificate programs or to commit to a lifelong career via a PhD in their chose specialty. There are various political science degree programs you can choose from depending on your level of education and background.

If you are a working professional or a student and you were not able to complete your undergraduate degrees in Political Science, you still have a chance to enhance your skills via an online certificate program or through an associate's degree. With a certificate program, you can build crucial skills in certain specialty areas. Working professionals can use these certificate programs in providing addition expertise so that they can qualify for career moves or promotions.

With an associate's degree, students become exposed to career opportunities in public service. Then again, many are reconsidering this option because competition is tough. As a result, online universities and colleges encourage their applicants to roll over their course credits and consider a master's degree program or a full 4-year online Political Science degree program.

When it comes to a master's degree in Political Science, you can use your life experiences as well as your previous undergraduate work in exploring deeper issues in politics and influence. This is a great way in deepening your understanding of the political structure and its noted influence on both domestic as well as international policies. Niche fields like nonprofit law, public policy, administrative theory, regulatory policy and labor management relations fall into play in these graduate programs.

If you are only aiming for a part-time degree, you can earn credits by completing a 2 to 5 year online Political Science degree program. This way, you can land in a career as a civil servant or as a campaign worker.

Then again, if you want to advance further and you are thinking of pursuing a Political Science doctorate degree, this is the best way to increase your chances of becoming leaders of private research foundations or tenured faculty members. Through an online Political Science degree, you can focus on deeper topics like transnational & comparative politics and policy; public administration; policy analysis and administration; justice politics and policy; as well as American politics and policy.

An online political science degree program is your best bet to succeeding in Political Science careers. This is the best and most effective way to learn certain skills and characteristics which can help you in your chosen field. This includes the efficiency in oral presentation; a more thorough understanding of the American political system; strong written communication skills; comprehensive yet accurate research skills; a better understanding of international politics & policy; as well as more effective interview skills & techniques.

To become certified as a teacher, you need to meet both local and state requirements. You may need to pursue continuous or additional education in order to maintain your eligibility. If you are applying at a federal agency, you would need to pass a complex entry exam before you can get a personal interview.

Thus, during the interview, you may even be required to join in role playing exercises. For a civil servant position, you would succumb to a rigorous background check. This means, if you have something to hide, you would need to divulge your incriminating and embarrassing information during the early part of the interview.

Once you pass the substance or drug abuse test as well as the background check, you can get a low level security clearance. As you advance to higher profile projects, you will also earn higher clearance levels.

Next, find out the best place to get a top online political science degree. Visit: http://www.DistanceLearningDegrees.org

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