Software
Laboratory Information Management System (LIMS) or Laboratory Information System (LIS)
Please find below our listing of possible software solutions for the Pharmaceutical, Medical Device or Life Sciences Industry wishing to comply with the FDA, TGA, MHRA regulations.
Laboratory Information Management System (LIMS) is computer software used in the laboratory for the management of samples, users, instruments, standards and other laboratory functions such as invoicing, plate management, as well as work flow automation. A LIMS and a Laboratory Information System (LIS) perform similar functions. The primary difference is that LIMS are generally targeted toward environmental, research or commercial analysis, such as pharmaceutical or petrochemical, and LIS are targeted toward the clinical market (hospitals and other clinical labs). We do not differentiate between the two systems on this site.
Today's trend is to move the whole process of; information gathering, decision making, calculation, review and release out into the workplace and away from the office. The goal is to create a seamless organisation where:
- Instruments used are integrated in the lab network; receive instructions and worklists from the LIMS and return finished results including raw data back to a central repository where the LIMS can update relevant information in the LIMS.
- Lab personnel will perform calculations, documentation and review results using online information from connected instruments, reference databases and other resources using electronic lab notebooks (ELN's) connected to the LIMS.
- Management can supervise the lab process, react to bottlenecks in workflow and ensure regulatory demands.
- External participants (department, company) can place work requests and follow up on progress, review results and print out analysis certificates and other documentation (perhaps even historically).
LIMS Software
| Vendor | Claim | Website |
| UNICORN Control System,V4.1 | Unicorn Control System version 4.1 was audited in May 2001 and was found to fully conform to all current and relevant US FDA guidelines and regulations including 21CFR part 11. | www.amershambiosciences.com |
| Q_DIS/R | The extended use of computer technology and the increasing automation in the field of modern chemical analytic, produces large quantities of analytical data. In consideration of: the diversity of data sources, GLP and GMP guidelines, governmental requirements (FDA 21, CFR Part 11), company objectives | www.creon.com |
| Chemstation Plus | The system enables users to comply with audit and approval requirements such as 21 CFR Part 11. | www.chem.agilent.com |
| Analyst SQL LIMS | Analyst™ software. Automated software routines rapidly and completely optimize the instrument for quantitative analysis. Queries, metric plots, configurable results table, and slide show. Analyst software provides flexible data acquisition, fast and easy data. SQL*LIMS® software is a complete LIMS that gives you control over sample tracking, laboratory processes and workflow, data access and storage, and regulatory compliance. Supports your laboratory’s compliance with the FDA’s 21 CFR 11 Rule. | www.appliedbiosystems.com |
| LABTrack | LABTrack incorporates (21 CFR Part 11). Electronic Signature is a mechanism to accurately identify the user of the software at the time data is saved. It can do so using either controlled passwords or biometric devices like fingerprint readers. LABTrack supports both. | www.labtrack.com |
| BlazeLIMS Enterprise Plus | BlazeLIMS Enterprise Plus provides flexible sample registration functions, including ad hoc logs, batch/requests, QC batch, and stability studies, with manual or automated results entry in a 21 CFR Part 11-compliant environment. | www.blazesystems.com |
| StatLIA | Brendan develops laboratory software for all immunoassay testing technologies. For automating workflow, the software is designed for easy interfacing and networking to any LIM system, instrument and PC. And all raw, computed and statistically analyzed data are organized, secured, and easily accessible. 21 CFR Part 11 Compliant. | www.brendan.com |
| SLIM | 21 CFR Part 11 Compliant; “All changes are event logged. Audit trail includes references to the date and time of the change, the user making the change, the event type that caused the event to be logged, and description. When data results are changed a change code and comments are logged. Multiple levels of security. “ | www.hascientific.com |
| Cerity | Agilent Cerity Networked Data System for Pharmaceutical QA/QC data system is part of the Agilent Cerity networked data system family of chromatography software. (Formerly Chemstation.) | www.agilent.com |
| 2.0 Dissolution data Management Software | The new Version 2.0 Dissolution Data Management software from Icalis Data Systems employ an extensive range of restrictive access rights to aid compliance to 21 CFR Part 11 and Online Sample processing with Auto samplers including sample dilution. An audit trail is kept of all activity in the system which is also user query able to help keep information in an orderly manner. | www.labocat.nl |
| Watson LIMS | Watson ™ has been expressly built to promote compliance with GLP regulations and the 21 CFR Part 11 guidance. Watson™ is capable of handling standard and complex study protocols, providing audit trails to track deviations and amendments to each study. Watson™ has full bi-directional interface capability to analytical instruments, tracks shipments and samples through user-designed barcode labels, supports a wide range of PK/TK analyses, and organizes study results in a unique document management system. | www.innaphase.com |
| Debra Laura | Debra, by Lablogic Systems, Ltd., is a Protocol-Driven GLP-Compliant Laboratory Information System (LIMS) designed to meet the unique needs of an ADME Laboratory environment. Laura 3 is the latest evolution. Laura 3 offers the researcher the facility to create and edit methods, set up sample runs and view data collection in real time across the network without being confined to the bench-top PC. | www.lablogic.com |
| LimsLink | LimsLink is the complete instrument to LIMS interfacing solution, designed to collect data from a broad range of instruments, reformat that data and report it to any LIMS or database application. With 100 levels of password protection and a full audit trail implementation, LimsLink provides the level of security and accountability required to make it 21 CFR Part 11 compliance. | www.labtronics.com |
| LabWare LIMS | LabWare's successful validation record and compliance to 21 CRF Part 11 guidelines are some of the reasons why many of the world's pharmaceutical companies have standardized on LabWare LIMS. | www.labware.com |
| Sherlock 4.0 | The MIDI Sherlock Microbial Identification System (MIS) is 21 CFR Part 11 compliant. Data is stored in a single, secure file that cannot be altered by ordinary means. Maintains data integrity such that data can be utilized to regenerate the original results. Provides designated personnel with capability to review, approve and electronically sign records. Creates an audit trail of all entries and actions that create, modify or delete an electronic record. | www.midi-inc.com |
| RESULT | RESULT™ Software Provides tools to comply with 21 CFR Part 11 Regulations The operation of Nicolet Industrial Solutions’ analyzers is simplified with its software. RESULT was designed for the specific requirements of process instrumentation. With digital signatures, an audit trail and Logon/Passwords, RESULT helps you meet the requirement of 21 CFR. | www.nicoletindustrial.com |
| ARCHIVE UNIFY VISION | NuGenesis provides an application-independent method for storing and cataloging raw laboratory instrument data as well as human readable information from common business applications. You can provide auditors with documented evidence back to the original source. NuGenesis Technologies products work as an application independent Scientific Data Management System (SDMS) which automatically aggregates data from disparate sources providing greater access and insight into critical knowledge generated in the laboratory. 21 CFR Part 11 compliance. | www.nugensis.com |
| WintSOTAX | WinSOTAX is a modular and configurable software package to collect data from various laboratory instruments, to store this data in a database, to retrieve it for analysis, monitoring and report generation. From the beginning the package has been developed following the rules of GLP, GALP and the GAMP guidelines. It therefore matches the requirements of 21 CFR Part 11 with few exceptions by design. | www.sofax.com |
| Nautilus Atlas | Nautilus sets the standard in delivering LIMS functionality into the laboratory. Nautilus includes assisting customers in complying with 21 CFR part 11. Nautilus can also play a compliance role in organizations certified to ISO9001 standards. Thermo LabSystems has been developing and supporting Chromatography Data Systems (CDS). Atlas™ is our latest generation validated CDS solution. | www.labsystems.com |
| GRAMS/A1 V7 | Thermo Galactic's latest version of its popular spectroscopy data processing software, GRAMS/AI provides tools to help laboratories handle data in a way that is compliant with 21CFR part 11 | www.galactic.com |
| ePMC | VelQuest's ePMC solution acquires data electronically at its source, links the data to analytical test procedures, secures the data and provides a platform for a wide range of IT applications. Furthermore, the VelQuest ePMC solution provides a means to meet 21 CFR Part 11, governing the use of electronic records and signatures in regulated laboratories. | www.velquest.com |
| NoteBookMaker | NoteBookMaker™ is a totally secure, completely electronic Laboratory Notebook. The first electronic notebook that looks and prints like a real notebook. This system is easily modified and can be custom designed to fit any organization. NotebookMaker meets the requirements of 21CFR part 11 | www.NoteBookMaker.com |
| LIMS | DUII develops and markets its products and services of LIMS, 21CFR11-aware computational infrastructure, and Standard Operating Procedure (SOP)-driven networks. These satisfy the requirements of 21CRF11 by authority check, operational system check, device check, SOP, electronic signature and closed systems. DUII creates tools to enhance communication and to enforce compliance. | www.duii.com |
The above table lists all the Software identified by PharmOut Information Technology.
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