Software
Laboratory Software
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 Instrumentation Software:
| Vendor | Claim | Website |
| Empower | Millennium 32 Chromatography data system. Adds complete 21 CFR Part 11 compliance, dual-tower control, and data acquisition support for Agilent 5890 and 6890 gas chromatographs and the Waters Alliance dissolution system, pattern recognition algorithms for chromatogram comparisons, and full support of Microsoft Windows web standards. | www.waters.com |
| Connect Turbochron | Use CONNECT to transfer data between SQL*LIMS and Turbochrom. With Turbochrom Client/Server, the embedded GLP/GMP features provide the most secure and documented data handling system ever. Turbochrom Client/Server provides controls for user and instrument access, user configuration of software menus and screens, file access, controlled modification of active methods and sequences and more. | www.insturments.perkinelmer.com |
| 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 | www.shimadzu.com |
| TeC | TeC, Taratec’s e-Compliance Solution, will help ensure compliance for computer systems used in all phases of the product development cycle. | www.taratec.com |
| 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. | www.zymark.com |
| 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. | www.scisw.com |
| 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. | www.pharsight.com |
| 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. | www.beckmancoulter.com |
| 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. | www.criver.com |
| OMNIC | Document explains at www.nicolet.com/labsys/pdf/21cfr.pdf how OMNIC is part 11 compliant | www.thermonicolet.com |
| 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. | www.biolog.com |
| Vision Software | Foss NIRSystems, Inc., a unit of Foss A/S of Denmark, is the world's leading supplier of scanning Near Infrared products and services for the pharmaceutical and chemical markets. Our extensive application knowledge, global distribution, and support network ensures efficient method development and routine implementation for years to come. Our software is fully compliant to 21 CFR, Part 11 for the benefit of our pharmaceutical customers | www.foss-nirsystems.com |
| DataPro/DataGuard | Ionics Instrument Business Group (formerly Sievers Instruments) makes the world's most sensitive and selective scientific instruments to measure total organic carbon (TOC) for the pharmaceutical, semiconductor and power industries. A 21 CFR 11 compliant Sievers brand TOC system is available with a new DataPro/DataGuard software package that includes audit trails, electronic signatures and user-level security. | www.ionicsinstruments.com |
| TOCTalk V3.5 For Phoenix 8000 | TOCTalk Version 3.5 combined with the reliable, high-throughput Phoenix 8000 TOC Analyzer is the ideal solution for today's Pharmaceutical water for injection (WFI) and clean in place (CIP) applications. | www.tekmar.com |
The above table lists all the Software identified by PharmOut Information Technology.
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