...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...
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...1. Difference between prospective validation, retrospective validation and revalidation. Prospective Validation * Carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps * These are then evaluated on the basis of past experience to determine whether they might lead to critical situations * Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. * The trials are then performed and evaluated, and an overall assessment is made * If, at the end, the results are acceptable, the process is satisfactory. Unsatisfactory processes must be modified and improved until a validation exercise proves to be satisfactory. * This form of validation is essential in order to limit the risk of erors occurring on the production scale, eg. In the preparation of injectable products. Retrospective Validation * Retrospective Validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged * Such experience and the results of in-process and final control tests are then evaluated * Recorded difficulties and failures in production are analyzed to determine the limits of process parameters. * Retrospective Validation is obviously not a quality assurance...
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...defined BOM of both products and stock solutions. 1. Security The application requires an extranet account. Username and password must be entered and validated prior to accessing the functionality. To access the BOM Validation, the user must have RPh roles and privileges. 2. Lot Validation: All barcoding on the handheld is associated with a lot number. The lot numbers can be either scanned or manually entered in the header portion of the BOM validation screens. The system will validate the lot number (and status) by returning the NDC and product/solution description. This information is validated on all RPh screens. 3. Setup: The setup function is a pre-requisite to any BOM validation. The set requires 4 pieces of information to be entered. The first is the label barcode which can be scanned into the available text box. The barcode value is validated against the product or stock solution barcode stored in extranet. The process will not continue until the intended product is matched to the label. The system also expects a barcode to be scanned for the Hood, Tech(s) and pump(s), associated with the production of the lot being scanned. When this screen is selected on a previously scanned lot, the scanned values will be presented. 4. BOM Validation: This module reviews the product or stock solution BOM and lists the ingredients and diluents as they exist on the FWS. A text box is present for each ingredient. The scanned vale for each ingredient must contain the barcode...
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...System Integrity and Validation - Kudler Fine Foods Theresa Gibbs Acc/542 October 29, 2012 Yasin Dadabhoy System Integrity and Validation - Kudler Fine Foods Over the past few weeks the team has analyzed Kudler’s information systems, recommended industry-specific software, analyzed its inventory data tables, and internal controls and risks for an audit proposal. After analyzing the necessary components the team recommends that an SAS 94 audit is appropriate for Kudler. To conduct the audit the auditor will use computer assisted audit tools and techniques (CAATTs) or in Kudler’s case computer assisted audit techniques (CAATs). The following brief is an explanation of how CAATs is used to validate data and the system integrity, and explain audit productivity software. CAATs CAAT is techniques that increase the auditor’s productivity and effectiveness during the audit function. CAATTs uses tools, such as software to increase the auditor’s productivity and extract data, and analyze the data in addition to the techniques. The techniques are used to validate application integrity and verify data integrity of Kudler’s information systems. “These techniques include generating test decks of data, writing and embedding automated audit modules, and performing digital analysis and linear regression on a client’s data” (Hunton, 2004, p. 179). CAAT assists the auditor in collecting sufficient, reliable, relevant, and useful evidence that supports the planned audit objects. The...
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...Question 1 (20%) In your own words, briefly describe your understanding of application of the lifecycle concept to validation. Process validation is a vital aspect not just for regulatory purposes, but also for the efficient and reliable long-term application of the process. In order to address the performance of the process adequately, process validation is used to identify the relevant parameters, to design the experimental validation studies accordingly and to define appropriate acceptance criteria through process development. Applying the lifecycle concept to validation, measures should be taken to routinely maintain and control the validated status of the process during initial development, its long-term application and until the process’s discontinuation. These measures include the monitoring of relevant performance parameters through good documentation. Question 2 (20%) What activities generally support the validation of a process / product? Activities that generally support the validation of a process / product include equipment calibration to ensure that the measured variable is accurately monitored; equipment qualification which includes installation qualification (IQ) an audit of the installation against the equipment specifications and drawings and operational qualification (OQ) which confirms that the equipment performs as intended; process development to provide documented evidence of the suitability of all critical process parameters...
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...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...
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...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...
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...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 *...
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...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...
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... 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...
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...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...
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...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...
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...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...
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...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,...
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.... 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...
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