...Literature Books SOPs Validation Examples Free Literature Glossary Usersclub Intro Log-in Register Preview Renewal Tutorials Risk Management Practices Computer Validation Part11 Method Validation ISO 17025 Lab Equipment Qualification Good Laboratory Practices About About Labcompliance Contact Labcompliance Scope Tax/Bank Information All come with 10+ Best Practice Documents: SOPs, Checklists, Examples Transfer of Analytical Procedures According to the New USP Chapter <1224> With SOPs, templates and examples for easy implementation March 21, 2013 Quality by Design (QbD) for Analytical Method Development and Validation Learn how to design robustness for easy transfer and to avoid OOS situations Recorded, available at any time Validation of Analytical Methods for GLP and Clinical Studies Learn how to design, prepare, conduct and document for FDA compliance Recorded, available at any time Eight Steps for Cost-effective Laboratory Compliance Up-to-date overview, hot topics and trends. Recorded, available at any time Verification of Compendial Methods according to the New USP Chapter <1226> Understand the new risk based approach and and get real world case studies for testing Recorded, available at any time Effective HPLC Method Development and Validation Preparation, conduct and documentation for FDA/EMA Compliance Recorded, available at any time Validation of Analytical...
Words: 10613 - Pages: 43
...Set-up Mobiles and Coaches 1.0 Purpose of Validation The purpose of this validation is to validate the Talisman Quality Donor System (QDS) upgraded release of 2.11. Initial validation of QDS was performed the following sites with operation dates listed: 1. RRVBC 6th Street site and has been in operation since June 18, 2007. 2. Perryville fixed site and has been in operation since August 27, 2007 3. Freeport fixed site and has been in operation since September 24, 2007 4. Mobile set-up/ Coaches have been in operation since April 1, 2008 This validation is being performed to ascertain that the systems upgrades function as expected at all sites of operation. 2.0 System Description We have validated the QDS system 2.03 and have an upgrade to that system which includes the following changes. 1. Question regarding xenotransplants and endoscopic exams with biopsy will be validated for visual display and audio quality. 2. Gender question will be asked and answered twice any inconsistency will stop the program and return to the beginning. 3. Travel history can now be edited even after record has been printed. 4. European countries list now includes the “Federal Republic of Yugoslavia”. 5. New version of Donor Consent. 3.0 Responsibilities Nancy McKinney, LPN is the Project Manager and will oversee the validation. The trainers assigned to the project, Larry Graham and Melissa Roush will perform the validation scenarios. The results will be reviewed by Laurie...
Words: 411 - Pages: 2
...aAPPLICATION CONTROLS Application controls are programmed procedures designed to deal with potential exposures that threaten specific applications, such as payroll, purchases, and cash disbursements systems. Application controls fall into three broad categories: input controls, processing controls, and output controls. Input Controls Input controls at this stage are designed to ensure that these transactions are valid, accurate, and complete. Data input procedures can be either source document-triggered (batch) or direct input (real time). Source document input requires human involvement and is prone to clerical errors. Some types of errors that are entered on the source documents cannot be detected and corrected during the data input stage. Dealing with these problems may require tracing the transaction back to its source (such as contacting the customer) to correct the mistake. Direct input, on the other hand, employs real-time editing techniques to identify and correct errors immediately, thus significantly reducing the number of errors that enter the system. Classes of Input Control a. Source Document Controls. Careful control must be exercised over physical source documents in systems that use them to initiate transactions. Source document fraud can be used to remove assets from the organization. In the absence of other compensating controls to detect this type of fraud, the system would create an account payable and subsequently write a check in payment...
Words: 2018 - Pages: 9
...Cache Coherence Considered Harmful Abstract Write-ahead logging and the Internet, while robust in theory, have not until recently been considered structured. In this paper, we validate the construction of digital-to-analog converters, which embodies the technical principles of concurrent steganography. We concentrate our efforts on disproving that the foremost event-driven algorithm for the study of the UNIVAC computer by Garcia et al. [5] is in Co-NP. Table of Contents 1 Introduction Unstable communication and multi-processors have garnered profound interest from both cyberneticists and systems engineers in the last several years. In this work, we verify the construction of massive multiplayer online role-playing games. An unfortunate quagmire in hardware and architecture is the visualization of the unfortunate unification of compilers and RPCs. Nevertheless, superblocks alone cannot fulfill the need for stable information. We question the need for scatter/gather I/O. In the opinions of many, the disadvantage of this type of solution, however, is that flip-flop gates can be made game-theoretic, low-energy, and amphibious. On a similar note, indeed, replication and IPv4 have a long history of synchronizing in this manner. Existing secure and extensible approaches use relational theory to visualize unstable configurations. We view programming languages as following a cycle of four phases: emulation, investigation, emulation, and creation. Combined with the World...
Words: 466 - Pages: 2
...Case Study Dakota Office Products The Main Learning Outcomes from Analysis of the Case Base on the analysis and investigation of the General Manager’s controller, and directors of operations, , the problem of the organization focuses on its relationship or connection with the employees and the customers. Regarding its relationship with its employee, the problem focuses on the distribution center as well as the desktop delivery of the organization where in it gives difficulties for the employees, because most of the personnel already had more than enough to do. It is important to consider the number of the cartons that are being processed during the year 2000. It can be said that the total number of the tasks is high compare to the current human resource or labor force of the company. In connection to that, the process of entering and validating customer order data also give tedious task. For example, the data entry operators have to enter each line separately. In addition to that, it is important to consider that the data entry operators are processing 16,000 manual orders and then validates 8,000 EDI orders. Where in each manual order has an average of nearly 10 items per order or in total, 15,000 order lines. On the other hand, due to the new EDI system and Internet page, it had made the life of the data entry operator, due to the fact that it set up the orders automatically without much intervention, on the other hand,...
Words: 376 - Pages: 2
...Hospitals Face Challenges Using Electronic Health Records to Generate Clinical Quality Measures Introduction The American Hospital Association (AHA) commissioned iParsimony, LLC, to conduct a study to investigate hospital experiences with implementation of Meaningful Use Stage 1 electronic clinical quality measures (eCQMs). The study describes the experience with and impact of eCQM implementation in four hospitals – large and small, urban and non-metropolitan – each of which had significant experience with electronic health records (EHRs) prior to Meaningful Use and uses a different EHR from a different vendor company. The findings described in the case study are derived from interviews conducted with key leaders and operational staff directly involved in the oversight and management of eCQMs. Based on the experiences of the hospitals in this case study, the current approach to automated quality reporting does not yet deliver on the promise of feasibility, validity and reliability of measures or the reduction in reporting burden placed on hospitals. Specific policy changes are needed, starting with Stage 2 Meaningful Use, to redirect the electronic clinical quality reporting requirements to focus on a small set of well-tested measures supported by a mature policy infrastructure that can guide valid and feasible measure development, testing and implementation. Background In the past 10 years, there has been an unprecedented expansion in the number and type of quality measures...
Words: 3750 - Pages: 15
.... Project Milestone 1 – 8 Name: Institution Affiliation: Project Milestone 1 – 8 Project Milestone 1 1. Identify at least two social psychology perspectives that could be used to interpret Jared's date preparation behavior. The two social psychology perspectives that can be used to interpret the preparation behavior for Jared's date entail: a. Learning Theory Perspective; this psychology perceptive focuses on the current behavior of an individual as determined by his or her previous experience. b. Motivational Theory Perspective: This perspective focuses on the individual motives or needs that influence behavior, attitudes and perceptions. 2. Provide a brief explanation of his behavior based on each of the two perspectives you identified. Learning theory perspective: the perspective states that the current behavior of a person is determined by previous experiences. From the preparation behavior of Jared to the date it appears that this is not his first date. As such, he wanted to select the clothes that he thinks flatters his body, and that shall show Alba that he has a good clothing taste. Furthermore, it might be in previous date that he had opted for a cologne that was feminine and as such, determines to choose one that does not smell feminine and not perceived as overpowering. Motivation theory perceptive: the theory focuses on the motive and needs of a person. Jared wanted to look at his best when attending the date with Alba. From the...
Words: 1879 - Pages: 8
... Music, literature, conversation, and every day behavior are used to form the black feminist consciousness. “Black women have long produced knowledge claims that contested those advanced by elite white men” (Collins 272). However black women have been denied authority to validate their knowledge which has left them relying on alternative knowledge validation processes. The consequences of this include academic disciplines rejecting claim, credentials denied, and pressure from authorities being placed on them. Just as Hemming’s decedents weren’t believed, neither are many black women. The standards of black epistemology include lived experiences, the use of dialogue, the ethics of caring, and the ethics of personal accountability. “Living life requires wisdom because knowledge about the dynamics of intersecting oppressions has been essential to US Black women’s survival” (Collins 275). The use of dialogue is important because black feminist thought is not formed by one person alone but rather by many people conversing. The ethics of caring show personal expressiveness, emotions, and empathy are central to the knowledge and validation process. The ethics of personal accountability are important in forming black feminist thought because people are held personally accountable for what they say. These standards are completely different from the standards held...
Words: 383 - Pages: 2
...connect data files, and perform queries. I think using the five basic steps helps diagnose problems because if a user is having problems they can always back over each steps to diagnose the problem, for example, let's say you are putting together a shelve and it doesn't look like the picture on the box, most likely you will return to the instruction manual and read the instructions step by step to see where you could have went wrong on your project. I think Edit and Validate Data could pose a problem for example when a user tries to edit field that has been set using validation rules you cannot edit that field, for example if a field is set to currency, you can’t put text in that field, you will then receive a error message, this can be annoying when Access is being used by multiple users working on the same table, like my assistant works with Access and she often has to edit the tables, if I set validation rules to my liking and she doesn’t have any knowledge that I have done so, she will wonder why she is getting error...
Words: 290 - Pages: 2
...We have all gotten into some sort of misunderstanding in the past. And I bet we've all gone through that conversation that goes something along the lines of, "What?… No but you said… No I had said… No but I didn't mean it like that…" So what what are the causes of miscommunication and how can we prevent them? Well the causes are fairly easy to define. And it all comes down to three things, words, filters, and context. When we read words, we only read part of the message. I cannot tell you how many times I’ve received an email and had no idea what to respond because i just couldn’t tell the message’s tone of voice. With nothing but flat words, the reader is left to their imagination to interpret the tone of a message. This can be a dangerous thing, as what a reader interprets could be the exact opposite of it's intention. Same thing goes for filters. Everything we say or hear is filtered through our own biases, prejudices, and experiences. And this doesn't just apply to one person, it applies to everyone. This presents a conflict when filters are activated in a different matter, hearing what we choose to hear instead of what we are intended to hear. Now when it comes to context, people sometimes forget the situation in which a statement was said. The sentence "I hate you" can be taken many different ways when put into different situations, it could either be a meaningless threat or the end of a realtionship, depending on it's interpretation. Misconstrued context can further complicate...
Words: 695 - Pages: 3
...| | | | | | | |INSPECTION / |STANDARD (1) |PROCEDURE AND/OR ACCEPTANCE CRITERIA |DOC |SAMPLE |CUSTOMER | |TEST ACTIVITY | | |Y/N(2) |SIZE |INSPECTION | |OPERATION ACTIVITY: 0010 |IN PROCESS | | | |VERIFY PART(S) HAVE RAW MATERIAL TRACEABILITY IS AVAILABLE BEFORE USE | | | | |DRSV010 |CAMERON STANDARD |METHOD- QUALIFIED PERSONNEL TO VERIFY APPLICABLE MATERIAL IS CORRECT BEFORE USE |YES |100% |- | |RAW MATERIAL | |STANDARD- CAMERON STANDARD | | ...
Words: 475 - Pages: 2
...Validation Consolidation Size This is my program that checks the validation of the size of an input from the user. It asks the user to input a password that must be exactly 8 characters long, if it is above or below it will ask you to enter the password again but if it is 8 character long then it will print the password that you inputted and say that that is your password. The user also has the option to restart the program. Size This is my program that checks the validation of the size of an input from the user. It asks the user to input a password that must be exactly 8 characters long, if it is above or below it will ask you to enter the password again but if it is 8 character long then it will print the password that you inputted and say that that is your password. The user also has the option to restart the program. Type This program is validating the type of an input by the user. What is happening here is that it will ask the user to input something and if it’s a number it will print true and if you type a letter or some other character other than a number it will print false. Type This program is validating the type of an input by the user. What is happening here is that it will ask the user to input something and if it’s a number it will print true and if you type a letter or some other character other than a number it will print false. Check Digit This program creates a check digit. What it does is adding up all the numbers in a string and whatever the sum of all those...
Words: 369 - Pages: 2
...Evidence Collection Cases 1. In this case the first thing that first responders need to recognize is that the computer was on when the suspect was arrested and there may be evidence that they need to collect right away. If data of apparent evidentiary value is in plain view onscreen. The first responder should seek out personnel who have experience and training in capturing and preserving volatile data before proceeding. First responders should also be alert to the crime scene environment. They should look out for pieces of paper with handwritten notes, passwords, usernames, and software and hardware manuals. These forms of evidence also should be documented and preserved in compliance with departmental policies. In this case the computer should also be checked for DNA so investigators can match the suspects DNA to the arson crime scenes. Also TimeFrame Analysis can be used to link any files of interest to the timeframes of the investigation. All these things can help link the suspect to the crimes, and in doing so can help tell the insurance company whether the claims are valid. 2. Case 4-4 (bomb threat) A list of what items should be included in an initial response field kit to ensure preservation if digital evidence. The initial response field kit should be lightweight and easy to transport. With this kit, you can arrive at a scene, acquire the data you need, and return to the lab as quickly as possible. * Small computer toolkit * Large-capacity drive *...
Words: 1243 - Pages: 5
...THE PROBLEM SOLVING 8D methodology Training plan 1. 2. 3. 4. 5. 6. 7. 8. 9. Introduction 8D history 1D – Estabilishing the team 2D – Problem description 3D – Containment action 4D – Root Cause 5D – Corrective action 6D – Validate corrective action 7D – Prevent recurrence 10. 8D – Verify and congratulate Team Introduction In any business firm or other organizations appear some problems, sometimes they are easy to remove and sometimes it seems that the solution is not possible. When problems occurred, run the proper action to eliminate the problem. However, often it turns out that the same problem appears again and usually in the most difficult moments - shipments to the customer . If the problem appeared again it indicates that the real cause is not resolved but only "heal" the problem temporarily, and his crux "cause" is not resolved . Sometimes the reason is defined the cause of the problem incorrect, and sometimes a lack of consequence in implementing such corrective action to prevent the same problem again appeared. Introduction To ensure a systematic and orderly way of solution to the problems, and their easy recorded is recommended widely known in the automobile market. THE PROBLEM SOLVING 8D Advantages: 1. Easy and logically method, cleary shows Next steps of problem solution. 2. The method is known and used by all companies from the automotive industry. 3. Often this is a required method of documenting the correction action for the customer. 4...
Words: 1368 - Pages: 6
...rapid turnaround? 2. Describe how these Critical Validation Issues are to be tested. This is pitched at the Test and Evaluation Master Plan level, but may show aspects of lower level documentation to justify certain decisions. a. What major activities are required and when could they be carried out? b. Are there validation issues that should be carried out as (or before) the system is under development to minimize or mitigate risk? c. Describe the resources that would be required for these test programs, including assessing when they might be realistically available? Shonky Enterprises have identified a shortfall in the market between slow sea freight and expensive air freight. Market research and analysis of historical data conducted as part of the Needs Analysis has identified what the end-user (the customer) requires and how Shonky will meet the needs of this niche market. Information on how the vessel will be used and any risks that the project may or may not be financially viable for the company have be identified as a number of Critical Operational Issues (COIs). The COIs are the absolutes required for the project as they detail what is operationally expected of the system. Failure to meet any of the COIs can not be tolerated. Validation of the vessels suitability and effectiveness will occur during OT&E; however, there is a critical requirement for validation of the T&E resources, primarily Modeling and Simulation...
Words: 5542 - Pages: 23
