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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

Mainsaver EAM

Cayenta's Computerized Maintenance Management Software is used by companies to minimize operation costs and maximize productivity. Mainsaver is a total solution for Enterprise Asset Management (EAM). Mainsaver offers a robust Enterprise Asset Management (EAM) solution, professional consulting services, implementation and training services and now compliance to FDA’s 21 CFR 11.

Entegreat

EnteGreat has helped our Life Sciences clients plan, select, design, and implement maintenance management systems in both large and small plants. We have helped customers roll out this type of solution on an enterprise basis, while reducing the overall systems implementation and long term ownership costs and speeding up your time to value and reducing your program risks

Avantis®

Avantis enterprise asset management system Foxboro I/A, Performance Measurement and Management Consultancy, Home Contact, Upstream Personal Healthcare Pharmaceutical Power Pulp and energy chemicals and maintenance. Updating asset maintenance procedures. Performance Measurement and Management group can help

MAPICS

With MAPICS, you can schedule and record maintenance functions; manage materials, components and products at multiple locations; and monitor operations at the plant, line or machine level. MAPICS Maintenance & Calibration Management provides you with the tools you need to properly manage your maintenance management program.

RSMACC

With a Rockwell Software Maintenance Solution you will no longer need multiple databases and spreadsheets to keep track of your people, the jobs they are doing and the tools they need to do their jobs. These activities are centralised, making maintenance more predictable and preventable. Software modules include Maximo Asset Management Software, RSMACC Maintenance Automation Control Centre.

IntoPlus.21 & Batch 21, eBRS

Aspen Technology Inc. announced new software solutions that provide pharmaceutical and other regulated process manufacturers with a broad range of solutions to comply with Title 21 of the Code of Federal Regulations.

ProcessPro

Decision Management International, Inc. develops leading-edge software for FDA regulated industries. The integrated solution set includes a robust document-authoring and control suite, resource-tracking suite, and an RF-enabled Weigh Dispense application. Products are engineered specifically for 21 CFR Part 11 compliant environments, and support electronic signatures, real-time data exchange with legacy systems, and handheld barcode scanning technology

CIS Chemical Inventory Sys

ChemSW announced a new option for its CIS Chemical Inventory System® that provides audit trail and electronic signature, for 21 CFR Part 11 compliance. The system incorporates multiple levels of security, transaction logging and signature verification. Ideal for use in pharmaceutical laboratory applications, the new security and audit trail option allows the system administrator to determine which users are authorized to make various kinds of changes, and enables accurate tracking of all change sources.