Laboratory Information Management Systems Revised Expanded 2nd Edition by Christine Paszko, Elizabeth Turner 9780824705213 0824705211

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Product details:

ISBN 10: 0824705211

ISBN 13: 9780824705213

Author: Christine Paszko, Elizabeth Turner

Details the most recent advances in Laboratory Information Management Systems. Offers contemporary approaches to system development, design, and installation; system customization; software and hardware compatibility; quality assurance and regulatory requirements; and resource utilization.

Table of contents:

1 Historical Perspecti

2 LIMS Fundamentals

I. Buying or Building

II. Process of Choosing and Implementing

A. Project Definition

B. Functional Requirements

C. Functional Design

D. Implementation Design

E. System Integration

F. System Evaluation

III. System Validation

IV. Feasibility Considerations

A. Automatic Calculations and Output

B. Reporting Requirements and Final Output

V. Operational Considerations

VI. Initial Implementation Design: Design Possibilities

VII. Considerations in Vendor Selection

A. Vendor Review

B. Other issues to consider

C. Inhouse Implementation Considerations

D. Availability of Resources

E. Provision of System Components

F. Final Implementation Design

VIII. Obtaining Laboratory Personnel Input: Needs Assessment

3 Data Management and Basic LIMS

I. Sample Login Function

II. Typical Information Collected at Login and Login Fields

A. Demographic data

B. Operational information

C. Financial/Billing Data

III. Sample Tracking, Bar Coding, and Quoting

IV. Utilization of Bar Codes and Automatic Identification Technologies

V. Biometric Identification

VI. Entering Results Data

VII. Reviewing and Approving UMS Results

VIII. Audit Trail

IX. Result Reporting

4 Data Management and Advanced LIMS

I. Sample Scheduling

II. Chain of Custody

III. Instrument Integration

IV. Quality Control and Quality Assurance

A. Quality Control

B. Quality Assurance

C. Specification Checking

V. Result Reporting

VI. Web Integration/Links to Enterprise Software

VII. Chemical and Reagent Inventory

VIII. Personnel Training Record Tracking/Instrument Maintenance

IX. Archiving and Data Warehousing

X. Developing a Backup Procedure for your Laboratory’s LIMS Data

A. Scheduling Backups

B. Testing and Storing Backups

C. Glossary of Terms: Tapes Used for Digital Back Up

5 Life Cycle of LI MS Software Development

I. Traditional Waterfall Concept

II. Pharmaceutical Manufacturers Association Life Cycle

A. Defining System Requirements

B. Design Phase

C. Programming Phase

D. Test Phase

E. Installation Phase

F. Operational Phase

III. Object-Oriented Approach

A. Analysis

B. Design

C. Evolution

D. Modification

IV. Design Considerations

A. Graphical User Interfaces

B. System Help

C. Source Code

D. Migration from a Manual LIMS

6 Regulatory Requirements

I. ISO 9000

II. ISO 25

III. Good Automated Laboratory Practices

IV. Electronic Signatures

V. Good Manufacturing Practices

VI. National Environmental Laboratory Accreditation Conference

A. Equipment

B. Calibration

C. Computers and Electronic Data-Related Requirements

D. Sample Handling and Receipt

E. Record-Keeping System

F. Laboratory Sample Tracking

G. Laboratory Report Formats

7 Hardware and Operating System Requirements

I. Computer Hardware

A. Central Processing Unit

B. System Memory

C. Hard Drive

D. Tape Drives

E. Optical Drives

F. RS-232 Port

II. Computer Networks

A. Physical Layer

B. Data Link Layer

C. Network Layer

D. Transport Layer

E. Session Layer

F. Presentation Layer

G. Application Layer

III. Computing Models

A. Single Processing

B. Shared Processing

C. File Server Computing

D. Client/ServerComputing

IV. Operating Systems

8 Obtaining Laboratory Personnel Input

I. Laboratory Work Flow

A. Sample Analysis Request

B. Sample Collection

C. Sample Login

D. Distribute Samples

E. Schedule Work

F. Analysis

G. Sample Preparation

H. Sample Measurement

I. Verification and Correction

J. Reports

K. Interpretation

L. Disposal of Samples

II. Management Functions

III. Questionnaire

IV. Paperwork

A. Data Sheets

B. Log Books

C. Reports

V. Laboratory Instruments

VI. Computer Network

VII. Personnel

VIII. Laboratory Standard Operating Procedures

IX. Quality Control

X. Accounting

XI. Leadership

9 Critical Elements in Preparing a Request for Proposal

I. Information for Proposers

II. Technical Specifications

A. System Configuration

B. Database Management

C. Sample Tracking and Management

D. Sample Identification and Receiving

E. Test/Analysis Administration

F. Bench Sheets/Work Assignments

G. Status Monitoring

H. Statistical Analysis and Quality Control

I. On-Line Queries

J. Reporting

K. Instrument Interfaces

L. Accounting Functions

M. Chemical Inventory

II. Product Support

III. Training

IV. Functional and Acceptance Testing

V. Proposer Information Questionnaire

VI. Cost Schedule

10 LIMS Evaluations

I. Written Proposal

A. Hardware/Software Configurations

B. Database Management

C. Sample Management and Tracking

D. Sample Scheduling

E. Sample Identification

F. Sample Receiving

G. Test Analysis

H. Bench Sheets

I. Status Monitoring

J. Quality Control and Statistical Analysis

K. Instrument Interfaces

L. Cost Functionality

M. Support

N. Documentation

O. Training

P. Expenses

Q. References

II. Scripted Demonstration

11 Enhancing Data Quality with UMS

I. Quality Control and Quality Assurance

II. System Validation

III. Steps to Limit Data Entry Errors

A. Data Entry Restriction

B. Double Data Entry Screens

C. Range or Limit Checking

D. Limit to List

E. Automatic Calculations

F. Automatic Reporting

G. LIMS and Data Validation

H. Decreased Turnaround Time

IV. Security

A. System Security

B. LIMS Application Security

C. Network Security

12 LIMS Validation

I. Principles of Software Validation

II. Life-Cycle Activities

A. Management/Project Initiation Phase

B. Requirements Definition Phase

C. Design Phase

D. Implementation Phase

E. Integration and Test Phase

F. Installation and Acceptance Testing Phase

G. Operation, Maintenance, and Support Phase

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Tags: Christine Paszko, Elizabeth Turner, Laboratory, Information