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What exactly is a [[laboratory information system]] (LIS) or [[laboratory information management system]] (LIMS) anyway? Do I need one? What options are available and how do I compare them? What about a request for information (RFI), request for proposal (RFP), or request for quotation (RFQ)? These are questions [[laboratory]] professionals typically ponder upon finding themselves charged with the mission of finding software for their lab. For many the task can be a daunting proposition.
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You may know the workflow-related needs of your laboratory, but perhaps you don't know much about [[Information management|data management]] solutions like LIS and LIMS, leaving you intimidated by all the options. You'll first need to gauge your lab's informatics needs in order to determine which products are worth investigating further. Of course your lab's analysis requirements, reporting and data sharing constraints, instrument interfacing needs, [[Barcode|barcoding]] and tracking requirements, quality assurance processes, etc. are very important factors. But these systems vary in numerous ways, and other important factors exist. Price should certainly be considered, although value is ultimately more important than a low price. Other important questions that get asked include:
==''Introduction to Quality and Quality Management Systems''==
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The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


*Should we purchase software licenses or "rent" the software via a subscription-based model?
;1. What is quality?
*Does the software need to be on-site, or is a [[Software as a service|SaaS]] hosted option more practical?
:''Key terms''
*Is a modular or complete system better for us?
:[[Quality (business)|Quality]]
*What is the best licensing/rental scheme for us? Should we consider site, named user, concurrent user, or workstation licenses?
:[[Quality assurance]]
*Is the company qualified and trustworthy?
:[[Quality control]]
*What functionality is available to help our lab not only accomplish workflow tasks but also remain regulatory compliant?
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


These and other questions are addressed in this chapter.
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Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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