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Life Science Companies & FDA: Change Control 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...... Similar Editorial : The Wages of Science by Sam Vaknin. | Source : Free Photo Software Download
Quality Control : Compliance Software And The Internal Audit In the world of FDA, ISO, EMEA and SOX regulations, life science, manufacturing and high-tech companies groan under the weight of regulatory compliance and audit procedures. Like so many unpleasant situations however these “regulation situations” are ameliorated only after a violent coup d’ etat. What?Well, in other words, the more control a company gains over their respective...... Similar Editorial : Out of Control by Hal Runkel. | Source : Free Bible Software Download
Employee Training Automated: Life Science Training Software For life science and high tech companies employee training is obviously essential. Employee training is also regulated by the FDA, ISO and additional regulatory agencies or organizations. For life science and high tech professionals employee training must be a priority but like many quality related processes manages to fall through the crack, especially during periods of critical design,...... Similar Editorial : Automated Forex Trading by Gerald Mason. | Source : Interactive Educational Software
Change Control Software Meets Change Control Goals An online exerpt1 states the goals of change control as follows:&bull Minimal Disruption to Services&bull Reduction in "Back-Out" Activities&bull Economic Utilization of Resources Involved in Implementing Change These goals though ideal are not always the final results for life science and high tech (e.g. engineering) companies who implement change control procedures. In fact, change control...... Similar Editorial : CNC Control Software by Ivan Irons. | Source : Interactive Educational Software
Clia Compliance Streamlining Software : Science & Lab Software The public eye is on the medical industry as well as big business. Gone are the days of deregulated science, business and technology. Today and tomorrow are days for regulation.Welcome to Big Brother land, right? Actually, regulation isn't exactly what it is often perceived to be.The Problem with RegulationThe problem with regulation isn't necessarily regulation itself. The problem with...... Similar Editorial : DIY Software by James Walsh. | Source : Interactive Educational Software
FDAA Cfr Part 11 Regulation On Electronic Quality System If you’ve dealt with a paper based quality system or even with a hybrid quality system, an online, centralized, electronically regulated quality system probably sounds like something akin to Nirvana, which probably isn’t far from the truth…at least as far as quality systems go!The FDA AgreesThe FDA too finds electronic quality systems (especially during audits) to be far more...... Similar Editorial : Carbon Dioxide Regulation by Anthony Fontanelle. | Source : World Wide Web Site
Glp Training: A Tool Is Better Than A Task Every laboratory’s checklist should include appurtenant GLP training for its employees but do you have to invest in a 3rd party trainer or is it something you can do yourself?GLP Training? Why is it necessary?GLP (Good Laboratory Practice) standards are necessary because before the GLPs were created not every medicine sold via a laboratory was effective or safe. Outright deception--though...... Similar Editorial : Training FAQ by Fred Tuxton. | Source : Music Theory Software
GLP Training: GLP Control In Non-Clinical Environments GLPs (Good Laboratory Practices) are meant to aid non-clinical laboratories in achieving consistent and effective product results over time.Like any quality-related regulatory practices, the GLPs, when managed poorly, are liable to cause dilatory pauses in production, which any good business professional---or researcher for that matter---is likely to resent. When all is said and done, it's the...... Similar Editorial : Training FAQ by Fred Tuxton. | Source : Music Theory Software
Electronic Regulatory Compliance Training & Life Science Industries Compliance with the FDA, the ISO, the EMEA, CLIA and additional regulatory bodies has long been a habit for successful life science companies. However compliance--like the unfortunate cat--can be skinned in more ways than one.The ProblemRegulated life science companies are required to manage and record essential training processes which include those processes devoted to regulatory compliance...... Similar Editorial : Regulatory Issues by Thomas Cutler. | Source : Music Theory Software
Change Control Applications | Life Science Software At the risk of sounding like a Disney movie, I will tell you a story. Let’s just say that one day I was having a bad day. You’re probably familiar with the scene. Glares, scoffs, and bad attitude were coursing through my veins. It also happened that on this particular day I was headed towards a gathering which I was more or less expected to attend. I didn’t want to go because (as...... Similar Editorial : Web Applications Compared by Valheru75. | Source : Programming And Software
Quality System Software For Laboratories A clinical quality system under the Clinical Laboratory Improvement Amendments (CLIA) relies heavily on the influence of laboratory directors. In fact, laboratory directors are ultimately and personally responsible for many aspects of a clinical laboratory's quality system. This article offers tips for clinical laboratory directors and their respective quality systems:Tip #1: Continued CLIA...... Similar Editorial : System Software by Jesse Miller. | Source : Audio Software
Change Control Challenges: A Few Ways To Beat Them Up Simply put, change control is the way that pharmaceutical, life science and technology companies (or any company for that matter) handle set-backs, “unpredictables” and upsets. Like people, companies have distinct ways of dealing with challenges and change. Some companies are calm……some have nervous breakdowns. The question is this: How can your company avoid the change...... Similar Editorial : Difficult Challenges by Miami Phillips. | Source : Computer Networking Book
Medical Device Quality Control | Abaxis D A recent Forbes article1 was disturbing. Not in the “nightmare sense” of the word or even the “weird sense”. It was more like the “pitiable sense”.Why?Well, the article began on a positive note. Abaxis, a medical device company located in California, has recently been successful in developing, patenting and distributing a machine that can quickly diagnose blood...... Similar Editorial : The Doomsday Device by Edward B. Toupin, Ph.D.. | Source : Computer Parts For Sale
Life Science Software & Quality Control Standards When it comes to quality control (in FDA regulated environments) and the implementation of quality related findings, successful performance is often determined by two factors: Whether or not managers and employees really concern themselves with superior quality standards, AND Whether or not the company in question has access to the right technological solutions. A New State of Quality...... Similar Editorial : Straddling the Science by Maya Talisman Frost. | Source : Computer Parts For Sale
A Quality System That Collaborates With Technology "I have always thought that the best way to find out what is right and what is not right, what should be done and what should not be done, is not to give a sermon, but to talk and discuss, and out of discussion sometimes a little bit of truth comes out." ---Nehru, Jawaharlal Indian statesman (1889-1964)Purposeful discussion with the purpose of eventual...... Similar Editorial : Quality Time by Gary E. Anderson. | Source : Environmental Technology
