Class VP

Supplier of Chromatography and analytical equipment, data files can be archived by VP Archive software if acquired on either Lab Solutions (GC) software or Class VP (HPLC) software interfaced with Shimadzu equipment

TeC

TeC, Taratec’s e-Compliance Solution, will help ensure compliance for computer systems used in all phases of the product development cycle.

TPW II

Engineered specifically for time-squeezed labs in a regulated environment, the TPW completely automates content uniformity and composite assay testing, from preparation through sample introduction and provides an audit trail consistent with 21 CFR Part 11.

EZ Chrom Elite

EZChrom Elite v2.7 chromatography data system fully complies with 21 CFR Part 11 Electronic Signature requirements. the signature information (Who, When, and Why) is stored within the data file with a CRC checksum to prevent tampering with the signature record. This information is also logged in the data file audit trail.

WinNonlin WinNonMix

Pharsight is also working with our customers to help them achieve compliance with 21 CFR Part 11 regulations. The Enterprise Editions of WinNonlin and WinNonMix are steps toward achieving this compliance which can be implemented today.

Pinnacle

Pinnacle is the first CDS to be designed from the ground up to meet Part 11 requirements. Not only do Pinnacle's electronic records meet Part 11 requirements, system administrators can also minimize the compliance burden by determining when electronic signatures and modification reasons are required.

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

Datastream

Numoda DataStream wireless solution enables the collection and redistribution of error free study data in significantly less time than existing methods. Eliminates time of testing and data entry Greatly reduces paperwork and overall costs Creates a virtually Error-Free Study environment, Works with any handheld device Secure and validated 21 CFR Part 11 compliant

EndoScan-V

Our EndoScan-V version 1.0.13 is the first endotoxin-specific software that addresses the 21 CFR Part 11 requirement for validation.

OMNIC

Document explains at www.nicolet.com/labsys/pdf/21cfr.pdf how OMNIC is part 11 compliant

MicroLog & OmniLog systems

The MicroLog and OmniLog systems are designed to exist within a 21CFR Part 11 environment and provide the basic functionality to support our customer's compliance efforts. Biolog provides all of the necessary software features, validation packages, and optional assistance to support full (including 21 CFR Part 11) compliance.

Chemstation Plus

The system enables users to comply with audit and approval requirements such as 21 CFR Part 11.

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.

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.

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.

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.

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. “

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.)

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.

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.