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Laboratory Information Management System (LIMS) and Text Information Management System (TIMS)

To increase lab efficiency, you can efficiently manage samples and associated data with the help of a Laboratory Information Management System (LIMS).

Laboratory Information Management System (LISM)

To increase lab efficiency, you can efficiently manage samples and associated data with the help of a Laboratory Information Management System (LIMS). Standardizing workflows, tests, and procedures with a LIMS ensures process transparency and accuracy. It is possible to integrate instruments into the LIMS to automatically collect test data while ensuring they are calibrated and operated by only trained personnel. An audit and revision control functionality within a LIMS is the main reason people choose a LIMS over a paper-based system. In contrast to a spreadsheet, the results as well as all changes to the instruments, reagents, and test procedures are logged.

LIMS Benefits and Advantages

In its full form, Laboratory Information Management Systems (LIMS) assist in three key areas:
  • Management - A LIMS assists labs in storing and retrieving results
  • Efficiency - Automating and speeding up mundane tasks is made simpler by a LIMS
  • Accuracy - Laboratories benefit from repeatable, accurate results provided by LIMS
  • LIMS software can help labs fulfill regulatory requirements such as GMP, FDA 21CFR Part11, and GLP by recording what lab personnel do and how they do it, while enabling efficient lab management.

How does a LIMS work?

LIMS are designed to reduce manual labor by improving lab efficiency and accuracy. LIMS are designed to handle a wide range of tasks. Typical functions include:
  • Inventory management
  • Reporting
  • Workflow management
  • Record keeping
It is possible for LIMS systems to differ according to their manufacturers and the level of support that they provide, such as mobile capabilities, customization options, and technical support.

Sample Management

The use of a LIMS is common in Sample Management so that samples can be documented accurately. Samples can be recorded with detailed information when they are first prepared or delivered to the lab, and that information can be enhanced and extended throughout their lifecycle. Typically, this includes information about the sample's origin, the lab researchers who worked on it, and how the sample moved through the workflow. Furthermore, it contains information such as how the product should be handled and its expiration date. A LIMS holds information about samples so that they can be lost, contaminated, or expire less frequently.

Reporting

Maintaining accurate and timely reports requires a LIMS. A LIMS can automate many of the tasks involved in maintaining daily, weekly and monthly reports. Additionally, lab workers have the ability to run ad-hoc instant reports, aiding them in making immediate decisions. In addition, readings can be taken directly from the equipment and input directly into the system for the highest level of accuracy when producing reports.

Inventory Management

A part of lab management on a daily basis is keeping track of inventory. LIMS systems can automate this process, ensuring that supplies are ordered based on the requirements in advance. As a result, the lab workflow runs smoothly and there are no delays or problems caused by low stock levels.

Workflow Management

By automating the assignment of tasks to researchers and outlining the next step in the workflow, LIMS can streamline a laboratory's workflow. Even based on pre-defined rules and criteria, it can suggest instruments and equipment.

Text Information Management System (TISM)

A scientist can use TIMS in today's workflow to facilitate writing reports by using a report template. Adding data and figures still requires some cutting and pasting. The scientist can send a link for the draft report to the reviewers after it has been completed. The "tracking change" feature allows the reviewers to make changes and corrections to the document. Authors have the option of accepting or rejecting the changes after the review is completed. A similar process can be employed if auditing is required. TIMS creates an unalterable PDF file after adding a date, if needed, and a signature to the finalized document. The document is version controlled for any subsequent changes. A document issued to end users can also be accessed remotely and electronically. When TIMS is compared with the old process, it has demonstrated its advantages.

Preclinical Development Documentation Needs

Specification documents and analytical test procedures - Drug substances and products used in clinical trials as well as stability samples are tested according to these documents. Handwriting a document out from a central location would be required if using a manual system. With TIMS, the analyst will have access to the documents via a secured database, and then after the test has been completed the documents should be destroyed.

Standard operating processors (SOPs) - In the same way that specifications and analytical methods are controlled, so are operating procedures (SOPs). Be sure that the scientists are using the correct version of the Standard Operating Procedures. NDA/MAA applications must include documents such as stability reports, reports on method validation and transfer, and reports on pharmaceutical development.

Laboratory notebooks - Notebooks for laboratory use contain information on experimental procedures, observations, raw data, and other critical elements.

Current TIMS Products

A TIMS is a simplified version of an electronic document management system used in preclinical studies. In terms of enterprise platform vendors, Documentum, FileNet, Interwoven, Stellent, and Vignette are among the leading players. Day Software, FatWire, and IBM are the companies with upper-tier products. These products are available from Ingeniux, RedDot Solutions, PaperThin, and Serena Software for a lower cost. In addition, TIMS systems are much more expensive to acquire and maintain than non-GMP/GLP systems. In early-phase development, thus, many documents that are not GMPs or GLPs are managed using TIMS that are not validated.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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