Software Reviews

With the FDA’s Critical Path Initiative paving a new road for various industries in the life sciences sector and the 21 CFR Part 11 regulation implicitly recommending the automation of quality and compliance process management in pharmaceutical environments, change is on the horizon for the burgeoning pharmaceutical sector.

Automation in the Pharmaceutical Sector

If your company, like other pharmaceutical companies, is considering the automation of GxP process, quality management, quality audit, compliance and document control processes, consider the following benefits that increased automation in the pharmaceutical sector should provide:

1. An increased ability for participants to virtually communicate regarding process information, documentation, etc.;
2. Full or partial elimination of redundant and iterate administrative tasks often associated with excessive man hours and spare amounts of actual production or achievement (i.e. using manual process to manage documentation essential to the approval and future of billion dollar drug compounds);
3. A more effective unification of quality departments with all other area departments (purchasing, manufacturing, etc.) in terms of understanding and real-time information. In other words, pharmaceutical professionals need to know how the processes they adhere to affect other processes throughout the company.

Achieving Automation Goals

To achieve automation goals, most pharmaceutical companies would do well to start by investing in a web document management solution that can be launched from the same platform as other solutions designed for the life science industries (i.e. GxP process control, quality management and quality audit solutions). The web document management software should also provide the following features and benefits:#1: A History of Successful Validation

Quality assurance professionals and other pharmaceutical professionals know the importance of reputable software validation. When searching for a web document management solution, pharmaceutical professionals should pay close attention to its validation history.

#2: Speed

Let’s get real. The only reason any pharmaceutical company would even consider the purchase of a web document management solution would be to save money and time on the product-to-market pathway. If any given solution does not automate and increase the speed of document change processes, document approvals, notifications and document distribution, then the solution isn’t worth consideration.

#3: Time Required for Installation, Implementation and Validation-Affects on ROI

Some software vendors may tout the strengths of their software and its immediate capacity for providing a healthy ROI. However, they may conveniently fail to mention that their installation, implementation and validation processes may stretch into 6 months, a year or even longer. Pharmaceutical professionals need to search for a web document management solution that provides a healthy ROI but that makes a clear statement regarding the time that will be required for installation, implementation and validation. A clear statement will allow pharmaceutical companies to make transparent decisions and effective planning for the upcoming transitions that are inevitably linked with the switch to automated document control.

#4: Configurable and “Off-the-Shelf”

If pharmaceutical companies prefer an off-the-shelf web document management solution, it must still be configurable to the unique needs of every company that purchases it. Some pharmaceutical companies for instance may not apply the same steps throughout a routing or collaboration process and the web document management solution should be able to reflect that.

#5: Tracking and Audit Trails

The web document management solution should also provide tracking and audit-trail features as well as sophisticated revision controls and reporting features.

#6: Electronic Signature Controls

To comply with 21 CFR Part 11, pharmaceutical companies must employ electronic signature controls. A web document management software solution that automates document signings routing and collaboration is highly recommended.

#7: Compatibility with Other Existing Solutions

As mentioned earlier the web document management solution should be launched from a platform that will allow for the future launch of other solutions. These solutions may include GxP process solutions such as software for deviations identification, nonconformance identification, quality audit, customer complaint handling, change control and CAPA solutions. A submissions management solution particular to the pharmaceutical industry is also highly recommended.

Conclusion

Pharmaceutical companies are in a period of great opportunity and should be implementing less administrative man power and more time into research and development. The right software solutions can allow pharmaceutical companies a greater opportunity to do so.

Since its inception, the Internet has brought us many great things - a wealth of information, opportunities in E-commerce and practically any product or service one can imagine. The Internet is prevalent in many areas of computing and provides benefits for corporate networks and home users alike. For those who aren’t careful, these perks come at a price, one that can place your personal data at great risk.

While media coverage tends to focus on Internet predators and identity theft scams, there is one common threat more likely to affect you than any other - malware! Malware is a combination of the terms “malicious” and “software”, a type of program you do not want on your computer. Some of the most popular forms of malware include computer viruses, worms and Trojan horses.

Computer viruses have been around for years, long before the Internet came into play. In order to be effective it must be executed by human intervention which typically occurs when clicking on an infected file. A computer virus propagates throughout a compromised machine, infecting numerous files along the way. Similar to a human virus, a computer virus propagates itself to other machines to further spread the infection.

Computer worms are often confused with viruses as their methods of distribution and destruction are quite similar. There is one exception however - unlike a virus, a worm does not require human intervention to be executed. Once it gets into your system, it has the ability to launch itself. Although there have been a few exceptions, most computer worms do not infect system files, but propagate themselves to other host machines.

The Trojan horse may be the most complex of all malware. Though often associated with a computer virus as well, the Trojan is much different. It usually approaches you via email or website as a beneficial program. A Trojan may be disguised as a video game, download management utility or even anti-virus software. When installed onto your computer, it often downloads other malicious programs such as viruses and spyware.

The impact of malware ranges widely from subtle to catastrophic. It may simply slow down the performance of your computer or delete all of your important files. In some instances, an infection may become so severe that the machine becomes completely inoperable. With such consequences, its no wonder that the anti-virus industry is thriving with revenue.

Prevention

So what can one do to protect themselves from all the infectious malware circulating on the Internet? The answer is simple - prevention. You must learn how these infectious programs are contracted and practice those activities with caution. This includes general web surfing, handling emails and the files attached to them, and file downloads. A piece of malware never announces its presence and usually appears to be something interesting or useful.

Furthermore, you can implement continuous protection and secure your computer with reliable anti-virus software. Vendors such as McAfee and Symantec offer all-in-one solutions that will protect you from viruses, worms, Trojans and more sophisticated forms of malware like intrusive spyware. Without sound security, you’re one step away from being the next victim.

Hyper-V RC1 has hit the market a few days ago. Microsoft is working on making the biggest fuzz out of their newest product as usual. Although Hyper-V RC1 is in its final stages before being released as RTM, I believe Microsoft have to spend more time on the development of Hyper-V before releasing it. Hyper-V is still lagging behind the competitors on many fronts below are only few examples of it:

* Hyper-V still does not support Live Migration, and quick migration is not a downtime free Operation. VMware & Citrix Xen have already achieved this goal long back.

* Hyper-V has a very limited support for Linux Operating systems. Currently it only supports SUSE Linux Enterprise 10 SP1. In the other hand, Citrix Xen & VMware support most commercial distros.

* Hyper-V performance for Windows prior to Windows 2008 is not even comparable to them running under VMware. Its due to the face Hyper-V needs the guest OS to support Para-Virtualization to perform well. All Windows versions prior to Windows 2008 do not support Para-Virtualization.

* Getting Supported Linux versions to run with an acceptable performance on Hyper-V is a complicated task. A step-by-step example of how to do so is available at
http://www.itcomparison.com/blg/virtualization/hyper-v-suse-linux-enterprise-10-and-component-integration.html

* Hyper-V does not support memory over-Commitment which highly limits the number of virtual machines Hyper-V can run on a physical host when compared to VMware.

Due to the above reasons and many more, you should intensely study your virtualization options before you decide on implementing Hyper-V as your main Virtualization solution.

More than often I’ve search the web for clean free software files, only to find software free to try, but only for a limited time or with limited functions. Like anti-spyware applications you may use for scanning your computer, but to actually remove the threats found, you have to pay for it. A lot of free applications also needs a registration, and the risk of receiving spam, are great. In addition there is a extensive use of false advertising on the Internet, and it’s only after you have installed the application you realize it doesn’t do what it’s meant to do.

There is a lot of freeware sites on the net, and some of them are quite good, but then again a lot of them mixes freeware with trial software and shareware. Often you have to download and try it before you see if it’s really free.

Especially when looking for free games, there is a lot of advertising and bad promotion popping up. I don’t know but it seem a lot of people buy their software, not knowing you can get a free alternative, perhaps because of all the false advertisements on the net. It’s a jungle of bad sites out there, and to find the ones that’s actually not too good to be true, it’s starting to become a bit of a science. Or perhaps it seems easier to just have the salesman add the software you need than figuring out what you need and where to get it.

So how do you find the real free software?

If you would like more information on how to find freeware then visit the authors site here http://sundrytools.com

Are you interested to find out more about how you can watch live football broadcast with Satellite TV on PC? Being a huge football fan, I cannot afford to miss any of my favorite teams playing live. If you are a football fan like me, you can use any of the 3 ways below if you watch your favorite football teams live in action.

What Are The 3 Main Ways to Watch a Live Football Broadcast?

1. Join TV Station Websites for their Live Stream

The first method is to join sports channels websites that have a live TV streaming service. They will require a recurring payment plan or a pay-per-view fee, but they should offer you a free trial most of the time. The benefits are that you can expect excellent customer service and good quality images and sound.

The drawback is that the recurring charges can amount quickly into a big sum. Also, you are only getting to watch live football and no other variety of channels.

2. Download Satellite TV on PC Software

This is the method that I use because it is the easiest to setup and most value for money. You will not need any physical hardware equipment, and all you need is your computer or laptop, an internet connection and the software. I personally have this software installed on my laptop, so I can turn it on and watch all my favorite TV shows when I am outside.

3. Watch on a Television Set

Finally, you could also use traditional methods like watching with a satellite dish or with a cable TV provider service. Some people prefer to watch it on a big television screen. This method will require you to pay recurring fees, thus I have not chosen this method as I generally do not like to add items to my monthly expense list.

XP registry repair is truly a simple process if you understand which tools to use for the job as well as having an understanding of the most effective process to have to complete the cleaning and repair.

The following symptoms are associated with Windows registry problems: slow running computer, computer freezes, crashes, delayed responses, and problems adding and removing software programs. If you have already attempted to repair your computer with anti virus software and the product failed to find or eliminate the issue, your next step will be XP registry repair.

The following three steps will help you clean and repair your registry and have your PC running like new again.

Step One: Understand Your Current PC Issues

Making an effective XP registry repair on your PC always starts with understanding the problems that currently have surfaced. That way you can ensure that the problem is actually in the registry itself and also you will have a gage to compare against after you finish the process to follow.

Make sure to add as many details to your list as possible. If the problems only happen during the use of certain programs or processes, make sure to notate that.

You can certainly skip this action if you are already sure that your problem is in the registry and if you have no desire to go back and recheck after repair.

Step Two: Choose One of the Best Registry Cleaners for Free Trial Scanning

The trial scan in the best registry cleaner software programs is the same scan used for people with the full edition of the software. This is good news because it allows you to see what problems exist in your registry before investing in the software to complete your XP registry repair.

If the thought of choosing a software program overwhelms you, stop worrying. There are a variety of effective products to complete the registry repair for you. Each will do a great job. There are a couple of products that are a better value for the money and that detect and remove more errors, but the key is mainly to find a couple important features.

The first feature is simplicity of the software user window itself. If the software takes a support class just to learn to use it, it is a waste of time. The XP registry repair process is much too simple (with software) to require a complicated software interface. Each button should describe its function and all features should be at your fingertips.

Another important feature is a backup system that creates a file with your registry files and keys so that you are not stuck if you do not like the repair results. This saves you from having to go into your windows operating system to do the backup (though you can if you are not confident about the software).

If you are an advanced user, you may want software that allows you to specifically select keys and files you want repaired after the scan.

After choosing a product for your XP registry repair, choose the scanning that is most extensive to see what errors are found. The problems detected will display in a results window after the scan and will detail every file name. After this occurs, you can just move on to step three.

Step Three: Do the Repair to Rid of Your Computer Problems!

After your results are displayed, the software will guide you through the purchase and repair process. You will be given an option of licensing for one or more computers (multiples at a discount) and then you can proceed to the repair. Most of the ordering systems today are highly encrypted which keeps your transaction information safe.

Though the repair will fix your computer now, the best registry cleaner products have a one year license so you can maintain your PC on an ongoing basis. This is comforting because you may only have a few errors now but could have 200 more within a week.

After the repair is made (which takes seconds), turn off your PC and restart it to see the improvements. You can now go back to your initial list and compare your previous symptoms to the results from your XP registry repair.

Hackers have gone to new lengths in creating fake programs that use the name of popular programs such as Antivirus2008. In the case of the this rogue anti-spyware program, it has the same name that Norton uses for the popular Norton Antivirus2008 program. We all know that Norton has a good working and legitimate program. Now when the common computer user is presented with the fake program they may immediately think that it is a trusted program that is the same as or similar to Norton’s application.

The fact of this matter is the program Antivirus2008 that displays several pop-ups on your screen is the fake one. It may resemble other spyware removal tools but it does not perform anything like a legitimate spyware removal tool. All computer users must not confuse the fake program with the real one.

Many times programs just like Antivirus2008 (rogue anti-spyware program) are created to trick people into purchasing the full version thinking that it will solve their “issues” or computer problems. After the purchase is made is when you usually find out that the program that you downloaded does not remove the parasites or fix your computer. In the end you are left with an infected computer and an empty wallet. Now you cannot buy any gas to take your computer to the repair shop and you start to pull your hair out of your head.

Be extremely cautious of any anti-spyware program that you download especially when the name may look familiar such as in the case of Antivirus 2008. Make sure that you check the credentials of any program that you download to fix issues on your computer.

If you are infected with any of the rogue applications then you should use a removal guide such Spyware-Techie’s removal guide for Antivirus2008.

SAP B1 is really innovative ERP, dedicated to small business with great ambitions: MRP, discrete manufacturing or production, CRM, advanced warehouse management and inventory (pack and ship), service contracts (including functionality for creative warranty contracts and even rentals), HR with its ability to track employee hiring and certification history, accrual to cash switch in financial reporting, great support for multicurrency and worldwide localizations. SAP staying behind with its accounting software reputation is worth to mention. These and other features make this ERP application to be included into ERP selection and evaluation worksheet. Let’s come through some SB1 features on the executive level:

1. Sales Automation or Client Relation Management functionality. The modern competition dictates you the rule of non-solicitation, however if customer calls or contacts you - then you can register this call in your SAP BO CRM as the lead or opportunity to be your sales process indulgence. Of course indulging is not the only purpose of CRM module - the main idea is to organize your sales department and facilitate group work in presentation and sales cycle

2. Customer Vendor Consolidation. If you had previous experience working with mid-size ERP, then you probably remember that you would in the past have to pay extra bucks for such “large company” features as having business with partner, where it is in fact behaving both as customer and vendor. Good example is freight forwarding industry with monthly settlement report. SB1 has it out of the box, plus you can advance the reporting features to give you exactly what you or your transportation partners need

3. Light manufacturing. One of the popular demands is so called disassembly production order, when you get return from your customer and you would like to take pieces apart and place them back to your inventory warehouse bins

4. Self Implementation Pilots. Yes, SB1 is good fit for such risk free scenarios. If you have internal IT people with accounting background who are familiar with AR, AP, GL peculiarities or rather to say uniqueness of your business, then you can purchase one professional user license (around three thousand US dollars) and do it yourself with limited hourly rates based support from your SB1 partner or ISV.

To obtain an overview of the behavior of the R/3 System, you can record various processes during the execution of an individual object. To analyze performance problems with database accesses, activate the SQL trace and the buffer trace from transaction ST05.

The SQL trace records SQL statements. There may be considerable differences between the SQL statement formed on the ABAP level and the SQL statement that is received by the database.

A buffer trace lets you trace SQL statements that access buffered tables. SQL statements that access buffered tables can cause buffer reloads, which are indicated in a buffer trace. An SQL statement accessing a buffered table can result in a completely different SQL statement if it cannot be satisfied by the R/3 table buffer.

Additional tools include: the enqueue trace, which records enqueue requests or releases, indicating the enqueue key and the object involved; as well as the RFC trace, which records the RFC calls received or sent.

Initial screen :

To access the SQL Performance Trace, use transaction ST05 or from the R/3 initial screen, choose System ® Utilities ® SQL Trace.

Before activating an SQL Performance Trace for a report or a transaction, you should execute the report one time to prevent the buffer load process for the R/3 table buffer, the R/3 program buffer, and so on, from being included in the subsequent trace.

The trace can be activated in the production system without any risk of creating errors or inconsistencies.

The trace can be activated by any user and for any object. When activating the trace, ensure that you are not using multiple user sessions or running other processes such as background jobs or update processes under the same user ID on this application server. These activities would make the SQL Performance Trace difficult to interpret.

For each application server, there is only one active trace file. Therefore, on a given application server, only one user can activate a trace. The default size of the trace file is 800 KB. SAP recommends increasing the size of the trace file to 16 MB by setting the parameter rstr/max_diskspace to 16 384 000.

Overview of sql trace:
The R/3 database interface receives an SQL statement from the ABAP program and converts it to an SQL statement that can be processed by the database.

For each database operation, the SQL trace measures the time taken from the sending of the request to the database server to the receipt of the results for the request on the application server via the R/3 database interface (including the time spent in the network between the application server and the database server).

The data written to the trace file includes the database response time, a time stamp, the number of transferred data records, the database return code, the text of the SQL statement, and additional administrative information for each database operation.

There is no way to circumvent two important facts:

1. Web document management software can save medical device companies significant amounts of time (hundreds or even thousands of annual hours);
2. Web document management software can provide a healthy and relatively fast ROI for medical device companies.

To most medical device professionals, these facts may be as obvious as the sun at 12:00pm, but perhaps even these professionals may have failed to consider up close the multitude of hassles that can be avoided with web document management software.

8 Hassles that Can be Avoided with Web Document Management in Medical Device Environments

#1: Downtime

Although “downtime” can be pleasant time, it’s never a good experience spending an entire afternoon looking for the latest version of an SOP that was supposed to be signed and sent to the QA department three weeks ago.

#2: Disconnects with Training Procedures

What happens when an SOP or a protocol manual is significantly edited? Are the changes always effectively communicated to all affected employees? Many times necessary SOP and other document related training simply doesn’t happen which results in plenty of headaches, back tracking and more wasted revenue. Medical device professionals should search for a web document management solution that automatically triggers a change control process when essential documents are edited.

#3: Walking

Walking can be an enjoyable activity but when medical device employees are walking form office to office routing SOPs and trying to collaborate on essential documentation hundreds (if not thousands) of hours are wasted. After all, a medical device marketing application submitted one year (or even 6 months) earlier or later than planned can result if very significant profits or very significant losses.

#4: Document Version Mishaps

Automated document version control is sufficient reason for an investment in web document management. It is in the loss of final version documents or in the process of mistakenly revising old versions of a document that medical device companies waste a significant amount of time. Medical device companies should search for a web document management solution with sophisticated document version control and serious security features.

#5: In-House Validation

Okay, so validation isn’t exactly a benefit of web document management software (it’s actually a tedious pain) but if medical device professionals search for the right software solution, some software vendors actually provide validation scripts, services and validation consultation which means in-house validation can be avoided altogether.

#6: Learning Curves

Learning how to use a variety of various process management, CAPA, quality audit, or document control solutions in one working environment can become confusing. Medical device professionals should search for solutions that can be launched from a single platform.

#7: Approval Paperwork

What’s more tedious that the prospect of signing off on a stack of paperwork? Medical device professionals should search for a web document management solution that allows signoffs to occur electronically upon the receipt of a notification delivered via email.

#8: Change Tracking Woes

It’s common for medical device professionals to spend too much time trying to decide what document changes were made, when they were made and by whom. Medical device professionals can avoid change tracking woes by investing in a web document management solution that tracks documents and all document versions from start to finish.

Conclusion

For medical device companies, investing in a web document management solution create a series of benefits which are felt throughout the entire company.