Contents

Validating Calibration Management Software for 21 CFR Part 11 is a pain, but with the right mind set the process can be speedy and beneficial. Given some trade tips and good advice there is an easier way to plan, construct and execute a validated compliant management software for the pharmaceutical and medical world of metrology.

Validating for 21 CFR Part 11 and Calibration Management Software

Validating for 21 CFR Part 11 and Calibration Management SoftwareThe whole process of purchasing a software package, figuring out the auditing logs, purchasing a validation protocol purchasing training on the protocol, hiring help and filling out the 500 1,000 page document for 21 CFR Part 11 compliance is as tedious as it is mind-numbing. On the fun things to do list working on validating software for 21 CFR Part 11 falls somewhere between getting a root canal and walking on broken glass. All that said, as with any other torturous activity, validating software can be made easier and relief can be found given some tips.Choose the Right Calibration Management SoftwareIf the software being validated has already been purchased then ignore these next paragraphs and move on, otherwise read on. The task of finding the best fit software for any given company is a whole dissertation in itself. see the article entitled Software, Software, Everywhere Software, published in Callab Magazine, by Brad Price, President, One Red X Software, Inc. for a detailed process for finding the best software. The importance of finding acceptable, robust and stable calibration management software cannot be stressed enough. Too often companies rush into a software choice that will most likely be replaced in a couple years because of new technology or bad design.Briefly, here are the main points from Software, Software, Everywhere Software for choosing calibration management software:Evaluate the environment that the software will be run on and make sure that you have the hardware available for the software.Before seeking a software package sit down and develop a simple work process flow chart of your facility, starting from the time you contact the customer through the time you return the equipment to the customer.The next step is to determine what operating system and style platform you want to run on.Lastly, ask the right questions. Find out everything you can about the software company, references and what features the software offers. Is the software flexible for the long run and will technical support be available when needed? Ask the questions and record them to decide which software vendor is going to satisfy the needs of the company best.Understand the SoftwareBefore beginning the validation, it is prudent to actually know the software, so you will be able to speak intelligently with the vendor and coworkers optimizing the validation procedure. The 21 CFR Part 11 compliant software should have an auditing log and electronic signature function that would be important to find and understand well. Some basic understanding of the software will help immensely especially since the software has to be validated by the customer themselves. When the validation protocol is being executed, this basic understanding comes in handy as the user moves through the software validating functionality. The point is: time will be saved no matter how you look at, if you simply experiment with the software or have some basic knowledge of how the software works before going through the validating long haul.Setting up the EnvironmentBefore starting the validation process verify that the business practices for the software are in place and all the customizations have been completed for the software. Software packages usually have a lot of settings, customizations, workflow processes and reports that are set-up specific to a companies requirements. Make sure everything is customized correctly and ready for use before validating the software, this decreases the chance of returning to patch up things that change later. Talk with the vendor, validation experts and anybody else that may have experience preparing for a validation for that software.Schedule the CompletionCreate a deadline for the validation to be completed. Ask the software company how long approximately it takes to complete the validation document and schedule accordingly. Find out if the document can be completed by more than one person and if so the work of executing scripts may be split up between two or three persons. Have a validation expert review the document often to verify that the proper steps are being taken to make sure the document is being completed right the first time.Begin using the DocumentStart at the beginning of the document. This may seem obvious, but it is important to complete whatever prerequisites that the document specifies first before continuing in the document. The prerequisites often require that the system requirements are met and the environment is set-up correctly.The document should be straight forward and easy to use. So if something seems not quite right, something probably needs to be adjusted and calling the software vendor or validation expert is suggested.Here are some general rules as one goes through the validation process:Consider the option of testing the software on a copy of the softwares database, thus eliminating the chance of damaging real data or adding a slew of play data from the testing.If something seems hard or confusing, stop and call the vendor or have a validation expert review the document.For customized systems, the scripts in the document may not read exactly the same as it is in the software itself. Amendments may need to be made to the document to match these software customizations. So, if something cant be found or is drastically different in the document verify you have the right document version for the software and that the software hasnt been customized differently from the COTS (commercial off the shelf) system.If the software has a backup option, backup often! Who knows what kind of mess will be caused as the software is tested for all sorts of angles, that way you always have a stopping point to return to.In ConclusionThe validation process is not fun but maintaining consistency in completing it and staying in contact with the software vendor and validation experts will ensure a speedy validation. Good Luck!

Adobe Photoshop CS3: Top 5 Standout New Features

Adobe Photoshop CS3: Top 5 Standout New Features

Upon first digging into Adobe Photoshop CS3, a few features have really popped out at me as incredibly useful. I would like to offer a brief overview of some of these new ways of attacking your creative challenges using the latest version of Adobe's flagship app. PsCS3 will run you about $649 to buy it outright if you do not own any previous versions. If you own Photoshop 7, CS, or CS2, you are eligible for upgrade pricing - looks like $199 for the upgrade. Check Adobe's store on their website for more info. For more information about what comes in the different versions of CS3, and what your suite configuration options are, see my previous post.My current favorite five new PsCS3 features in order are:1. Nondestructive Smart Filters2. Quick Selection Tool & Refine Edge3. Photomerge with advanced alignment and blending4. Automatic layer alignment and blending5. Vanishing Point with adjustable angleFeature Overviews:* Nondestructive Smart FiltersAdobe has finally given us non-linear, nondestructive filters. Can I just say "HOORAY!" In the past, you applied filters and effects in a linear order: one filter would alter your image, and the second filter would alter your now altered image, and a third filter would alter the altered altered image. The problem with that workflow is that if you decide you want to slightly tweak the second filter, you'd have to either undo back to that point (losing your subsequent edits), or use the history palette to step directly "back in time" to the point before you added the second filter, add your "revised" second filter and then add your third manually. All too often, you don't quite remember what exact parameters you had set on that third one - or worse, your real world project involved applying 20 filters instead of the 3 in my example and changing the second filter would mean redoing the 18 that follow it. What a drag. Because of this issue, people developed many work arounds (often involving saving off multiple "partially completed" versions of files all over your hard drive with iterative file names, hoping that if you needed to go back to a certain point in time you'd be able to figure out where you needed to be), and while these workarounds were clever and well-conceived in many cases, there was a perfect, real solution, waiting to happen.The real solution to all this is what we have been given in CS3: Nondestructive Smart Filters. In this new version, each filter and effect that you apply to a layer, remains live and continually re-editable, in real time, and the parameters that you adjust will all cascade down through whatever subsequent filters or effects you might have added to your layer. These are savable, movable, copy and pastable, and most importantly scalable.* Quick Selection tool & Refine EdgeA design mentor of mine once told me "Photoshop is all about the selection. You select something, and then you do something with the selection. Nothing more, nothing less. Remember that, and you'll never go wrong using this app." Almost 10 years later, I must say she was absolutely correct. Using Photoshop is all about "the selection." There are more tools in Photoshop for selecting than for any other single task.As in just about every version of Photoshop that has ever been released, CS3 has made even greater strides in the area of "making your selection" than comes to memory in recent years. The new Quick Selection Tool used in combination with the Refine Edge palette is about the most helpful and clean way of selecting the edges of an object in your image that I have ever seen. This new revised Quick Selection tool is so smooth. You basically set the parameters of your Quick Selection tool - as if it were a brush - and paint the general area of your image edges (like trying to select just a kid and his soccer ball out of the photo of the big game) and Photoshop is watching what you do, and interpreting what you consider to be the general edges of what you are wanting to select and it figures out what's kid and ball and what's grass and goal posts and sky and crowd and selects just what you want it to. It's VERY fast and clean. Then, you can invoke the Refine Edge palette, and you have seemingly infinite control over exactly how the edges of that selection behave. Check out the palette to the right to get an idea of what you could do to "refine" that edge. With radius, feathering, smoothing, and various display settings, I believe this new combo will cut down on my masking and selecting time in a quantifiable way.* Photomerge with advanced alignment and blendingEver tried to stitch together a series of images that you took, that you intended to "put together" into a panorama? Even with some of the stand alone tools that have been available over the yearseven those for doing quicktime VR'sare clunky and difficult to use - with mixed results at times. I have always wanted something built into Photoshop to let me do these "photo merges" - I never expected that Photoshop would actually be able to automatically do it for me. This feature floored me. The technologies involved in my number four choice "Automatic layer alignment and blending" are at work here in this feature as well, and the new auto layer alignment features in CS3 are far-reaching and crop up again and again in different areas of the application. It's really one of the revolutionary things about this new version.All of the things that have made making panoramas a difficult task in the past are all done automatically. The primary among these being 1. those times when you have to actually distort, rotate, skew or transform one of your elements because the perspective is screwy, 2. those times when the sun or lighting or a window made the white balance, color space or over all wash of brightness and contrast different from one image to the next (especially when doing 360's) and of course 3. actually finding and aligning those overlapping areas of consecutive elements. Photoshop CS3 does these all for you and with surprisingly amazing results. It's not just about the typical "panorama" either... I saw a demo of someone standing "too close" to a building, and taking pictures zoomed all the way out, of the front door, windows and window-boxes, front brick walk way, tilting upward and taking a picture of the balcony and roof line of the second floor - in other words, many elements that were WAY out of whack in terms of perspective, lighting and color space, and these 4 or 5 images were distorted, tweaked, rotated, matched, blended, lighting and color density matched... and I was amazed in like 5 seconds, there was this "wide angle" almost "fisheye" photomerge of the front of the building, from brick walkway to roof-line, and it looked incredible.* Automatic layer alignment and blendingAnother powerful application of this new alignment and blending technology is with a series or stack of images of the same subject. Let's say you wanted to take a picture of a statue in a park somewhere, or a huge fountain, or the front of a monument or building. There are always people walking through the frame - if you can't close down the area and still need a picture of the statue, in the park, in it's beautiful setting, but with no people or birds or random elements - what are you to do? In the past, it was a painstaking process of shooting a bunch of images, selecting the "closest" one to your vision of a nice, clean, tourist-less frame, and begin the hours and hours of painting, cloning, healing, brushing etc., to remove all of your "randoms." There are artists who are very good at this process, but I'm fairly certain they would agree that if there was a way to not have to spend all that time, they'd take it. Well, it's here. Photoshop CS3 can take your stack of images and by analyzing all of them, figure out which things are permanent (things that appear in all the images like that building in the distance, the big tree, the sidewalk, and which parts of the image are obscured in one of the frames but not all of them, are healed automatically by borrowing pixels from other images in the stack and building an advanced composite of all the images and doing 90% or more of the work for you. There's even a set of "fuzziness" sliders letting you say "eleminate things that are in X% of the images in the stack or less." This is so impressive to see in action. You have to try it on some of your own images. It's really hard to believe that it's this easy to do this sort of process now. This is one of those new areas that I'm sure we'll see artists finding incredibly creative ways to utilize this feature. Again, this one floored me when I first saw it.* Vanishing Point with adjustable angleOne of the most powerful new features of Adobe CS2 was the vanishing point feature. One limitation it had was that you only had one set of right angles to work with in the vanishing point interface. Adobe took it one exponential step further by adding multiple, adjustable angle perspective planes to this vanishing point feature. What this enables you to do is copy, paste and clone in far more complex image planes than just the "clone parts of a building in perspective" job that the first iteration of this feature offered (impressive and powerful, but not very flexible). One of the big examples Adobe is pushing with this feature is to simulate 3D packaging and work on multiple planes at various angles in the same image. Like an open box for a new product, or even for experimenting with your final package art by seeing it in its real-world context. Again I think this feature has so many far reaching implications for inventors, prototypers, 3D modelers, visual effects artists... and can give Photoshop artists the ability to render full blown mockups of product packaging art for clients in a whole new way - getting us to sign-off, green-light and on to the next project at hand much more quickly. I like that a lot.There are numerous new features in the application, especially when you dig down deep into the Photoshop Extended editions (sounds like a Peter Jackson DVD...) and as the week progresses here, I'd like to look into some of what PsCS3 Extended has to offer. The versions of PsCS3 that are available are the Film & Video, Medical & Science, AEC (Architecture, Engineering & Construction), and Manufacturing editions.

Taking advantage of Open Source PHP MySQL applications

Taking advantage of Open Source PHP MySQL applications

One obvious solution is to approach a software development company and obtain a custom built product. However to take this approach one needs to first know what features and functionality is desired. Then on the other hand in some instances the need does not warrant the cost of commissioning a custom application.A plethora of free open source web applications exist today. Regardless of the specific circumstances of the need these applications can quite often prove to be a valuable resource.http://freshmeat.net is one of the best online directories of open source applications. A quick search on freshmeat.net for say "intranet", "cms" or "groupware" will yield pages of results. Browsing these results any application marked beta, stable or mature is a possible solution. A large majority of the available web applications would also state PHP + MySQL as the platform.Oh well I need to have some Linux Server and it's way too hard is a common reaction. Fortunately this is not entirely true. If you wanted to host a large scale production site then the chances are that a custom Linux server may well be a requirement. However just evaluating on your own PC, or setting up a solution on your LAN for anywhere between 1 to 100 users can be easily realized without custom Linux servers.The solution is in another open source free product known as WAMP server. The acronym stands for Windows Apache MySQL PHP server. WAMP is extremely simple to install and a good platform for either evaluating PHP + MYSQL applications or operating the same for up to a few hundred users.Visit http://www.wampserver.comOr http://www.wampserver.com/en/ for the English versionFirst it is important to note that most open source PHP + MySQL applications will not run correctly on the latest versions of PHP and MySQL. For this reason instead of the downloading the latest version of WAMP server click on "downloads" from the left menu and then click on "older versions at sourceforge" This will take you to https://sourceforge.net/project/showfiles.php?group_id=116092scroll down and select "WAMP5 1.4.3". Download the WAMP5_1.4.3.exe file and install it on your computer with default options.Once installed and started a new icon will appear in the icon tray near the date/time on your task bar. Left click on this icon to activate it's menu which allows you to restart or edit the configuration files.Changing the web server port if necessary.One common reason for wanting to edit configuration file is in case you already have a web server running on the same computer. In this case you would need to change the port address used by apache to something other than 80. In this case 8080 would probably be a good alternative choice.-------Changing the web server port address Begin-----------Click on the WAMP server icon and from the menu under "config files" select "httpd.conf". A long text file will open up in notepad. In this file scroll down to the line that reads "Port 80" and change this to read "Port 8080", Save the file and close notepad. Once again click on the wamp server icon and select restart all services. One more change needs to be made before we are done. In Windows Explorer find the location where WAMP server was installed which is by Default "C:\Wamp". Next goto the subfolder named "www". Inside here you will see another subfolder named "phpmyadmin". We are looking for a file named "config.inc.php". In a default installation this file will be at "C:\Wamp\www\phpmyadmin\config.inc.php". Open this file in wordpad and find the line that reads$cfg['PmaAbsoluteUri'] = 'localhost/phpmyadmin/';Change this line to read:$cfg['PmaAbsoluteUri'] = 'localhost:8080/phpmyadmin/';-------Changing the web server port address End-----------Now open a web browser and access http://localhost . Or if you changed the port address to 8080 then goto http://localhost:8080/ You should be greeted by the WAMP welcome page. For each application that you wish to install create a new folder inside the "www" subfolder of where WAMP was installed. Lets assume that WAMP was installed at "C:\Wamp".Let say for example you wanted to install Mambo (www.mamboserver.com)1)You would download the .zip or .tar.gz or .tar.bz2 file and uncompress it using winzip or winrar into "c:\Wamp\www\mambo".2)You would access the wamp welcome page http://localhost/ or http://localhost:8080/ and access phpmyadmin. In here you would create a new database for mambo.3)You would then access the wamp welcome page http://localhost/ or http://localhost:8080/ and from the list at the bottom of the page you would click on Mambo4)You would then be greeted by the mambo installer which is a simple 5 step process. (the default username for MySQL is root and the password is blank as in an empty string)Let say for example you wanted to install oscommerceYou would download the .zip or .tar.gz or .tar.bz2 file and uncompress it using winzip or winrar into "c:\Wamp\www\oscommerce".5)You would access the wamp welcome page http://localhost/ or http://localhost:8080/ and access phpmyadmin. In here you would create a new database for oscommerce.6)You would then access the wamp welcome page http://localhost/ or http://localhost:8080/ and from the list at the bottom of the page you would click on Mambo7)You would then be greeted by the oscommerce installer which is a simple process. (the default username for MySQL is root and the password is blank as in an empty string)And so on and so forth.Any PHP + MySQL web application which does not provide an automated installer is most likely not a very mature application. Good luck

Asset Tracker for Networks: Network inventory solution

Asset Tracker for Networks: Network inventory solution

Asset Tracker for Networks is an inventory control tool for auditing software and hardware components installed on the network computers. This asset tracking software will collect your invenory control information, provide the Network Administrator with detailed comprehensive reports and allow him to export invenory information to external data sources. It is an excellent solution for auditing all types of software assets in a corporate network including, but not limited to, operating system details, processor, memory and hard disk drive information, software inventory, network printers, network adapters, operating environment and much, much more.This inventory software does not require any network setup on each individual network workstation. Instead, the Network Administrator starts the program on his/her workstation and clicks the Inventory Network button. The program inspects the network setup to find computers and network devices there and automatically provides the Network Administrator with the network management information on each computer or device found in a few minutes.Asset Tracker for Networks offers statistical reports for your needs. General workstation information report, processors, memory and operating systems reports, installed software and software licenses reports are already included with Asset Tracker for Networks. Additionally, you can request more specific types of reports which can be tailored to your requirements or even develop them by yourself.Asset Tracker for Networks also offers an easy way to export inventory management information to ODBC data sources, CSV files, text files, web pages or to Excel. The program's template-based export engine allows the user to add new export types without changing the program itself. You can also create your own export types or order export type creation from Alchemy Lab.The price of Asset Tracker for Networks 2.0 ranges from $199 for 25 PC's to $799 for 500 or more PC's. Site and Worldwide licenses are also available. Further information and a fully-featured trial download are available for free from http://www.alchemy-lab.com?c=art.

CMMS - Computerized Maintenance Management Software

Maintaining physical ledgers for all your maintenance activities is a tedious task. Nowadays there are freely available Maintenance Management Software that can be used for your maintenance management tasks. There is also software that you can buy for a nominal cost and you get your return on investment very sooner than you expect. It is easy to maintain your assets, work order, plans and schedules, and inventory with the help of maintenance management software (CMMS). You can easily keep track of your assets and perform different maintenance management tasks using this software.You can try the free versions available with many service providers and then decide on buying the full version that gives you more advanced features. Although maintenance software is available in the default language as English, it is also available in other languages like Chinese, Spanish, Malay and other languages. If you do the maintenance work manually by using physical ledgers, it is not an easy task to do the reporting and the analysis part of your job.With computerized "maintenance management software" ( CMMS ) you can easily do the reporting and the analysis. There are software manufacturers who provide you with simple and easy to use modules for your individual requirements. Modules for maintaining assets, work order, history of transactions, managing maintenance policies, different offices and locations from within the single module, invoicing, readings of different equipment, and permits for doing the maintenance work are available separately. These modules are integrated in full fledged maintenance management software. The most vital module for maintenance management software is the reporting module. The reporting module is important to monitor the progress of the maintenance work and also to help you improve your work.What ever be the number of equipments you have in your factory or office, it is better to have maintenance management software to track the maintenance work of those equipments. Since this software makes the maintenance management easy you are free to use the time saved, on other tasks in hand. Software companies also can have such maintenance software to keep track of their software, associated licenses, and the number of installs. Web based computerized maintenance management software is also available with different types of services from many companies. You can avail these services if your factory or office are located in different locations within your country or in different countries. With web based CMMS all you need is a browser and an internet connection to use this software. The details of transactions and records, in a web based Cmms Software, are maintained in a centralized server and the users will be using this data through the browser. There is no need for custom built client software for most of web based maintenance management software. Organizations that have multiple offices and factory locations can benefit from a web based maintenance management software. For different types of maintenance management software that is available in the market you can check out websites like http://www.cmmssystems.com

How To Slow Down Music A Guitar Players Dilemma

Since the early days of young guitar players career it is clear that practice makes perfect. As simple as it may sound, it involves a lot of time, patience and devotion in order to achieve the desired results in a timely efficient manner. Guitar students are listening to a lot of songs, doing their best to train their ear by tuning their guitar by ear, listening for the notes or even singing the notes, while not mentioning the constant practice lessons required to fine-tune their guitar skills. Everybody loves to listen to guitar solos like the ones achieved by world-wide famous guitar players such as Jimi Hendrix or Joe Satriani but few can even dream of reproducing their songs at the early days of learning to play the guitar . For this reason, the requirement and method of properly slowing down music has attracted the attention of many.Not just once has one listened to Joe Satriani Surfing with the alien and tried to follow the amazingly fast guitar notes. Ever thought about Joe Satriani sitting next to you and singing riff after riff so that you could follow him? Hard to imagine but now this is almost possible. Even if the great guitar player will probably not be able to sing for you in particular you can now slow down music and learn note after note in order to be able to follow some of the worlds greatest guitar hits such as Purple Haze, Metallicas Fade to black, A whole lotta love and Sweet Child of Mine.The ability to slow down music and obtain the results mentioned above is now possible with your very own computer and of course some of the major songs mentioned above or practically any other complex guitar based song, according to which one you would like to study in more detail. Having this said it is clear that you can be a better guitarist from the first day of using Riff Master Pro, the Windows Vista compatible slow down music utility created by guitarists for guitarists. By considering this feature rich application you will be able to master guitar solos faster and at a much higher pace because of the instant functions which allow you to slow down music without damaging the songs quality and without having to change the pitch, a very important aspect when applying such a process.The magic of playing by ear is of course possible to just about anyone because of the extreme benefits brought to every PC user by quality software designed to fit exactly the most common guitar students requirements. While being a great utility for guitar students, Riff Master Pro has been since long time used even by some of the most veteran guitarists for testing purposes, all credentials being excellent, according to this products testimonials. Not only that we managed to learn to play the guitar faster, better, more but we are also now able to train our speed and ear at both beginner and advanced levels.The benefits of a good slow down music product such as Riff Master Pro are crystal clear to both guitar players and listeners as differences in style and accuracy of musical performance have been observed in most cases.

Summary

Validating Calibration Management Software for 21 CFR Part 11 is a pain, but with the right mind set the process can be speedy and beneficial. Given some trade tips and good advice there is an easier way to plan, construct and execute a validated compliant management software for the pharmaceutical and medical world of metrology.