Software
Enterprise Resource Planning 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.
ERP Software:
| Vendor | Claim | Website |
| Silverstream V2.5 | Janssen have successfully removed the paperwork from the change control process The system is compliant with FDA regulation 21 part 11. Because the system is intranet based, changes or amendments can be made at server level and deployed immediately. | www.clients.ie/home_static.html |
| Mobil Data Acquisition | The Sycamore Group is helping companies comply with 21 CFR Part 11 through Mobil Data Acquisition. Mobile wireless devices provide laboratory technicians immediate and real-time access to environmental data systems while meeting regulatory compliance standards. The real-time communication eliminates redundant data entry time, reduces the need for redundant testing and ensures data integrity. | www.thesycamoregroup.com |
| PAS-X-MES | Werum supplies perfect technical MES (Manufacturing Execution Systems) solutions and services for the GxP/FDA related pharmaceutical industry in compliance with 21 CFR 11. The standard PAS-X MES product range provides easy qualification and validation. PAS-X supports a rich set of features that help to streamline the whole pharmaceutical production process e.g. Electronic Batch Recording/EBR | www.werum.com |
| eGMP | A complete, integrated software solution that enables companies to create custom enterprise software. The eGMP software suite comes preconfigured with custom data table templates, enables companies to manage ALL aspects of workflow, from SOP, Specifications, Methods, Validation Reports, Qualification Protocols, and Design Reviews to time card management, procurement, inventory and more. eGMP has a complete security model built in. eGMP is compliant with FDA regulations, including 21 CFR Part 11. | www.egmp.com |
| POMS | Honeywell-POMS Corporation is the global leader in providing Manufacturing Execution Systems (MES) for the healthcare products and consumer packaged goods industries. Honeywell-POMS provides integrated solutions that help you control, track, and view every aspect of your product development life cycle. POMS products deliver value and help you | www.poms.com |
| JD Edwards OneWorld | Designed to meet the needs of regulated companies, J.D. Edwards OneWorld solutions not only ensure the integrity of authorized signatures executed within the OneWorld environment, they also enable companies to feel secure that the transactions being executed are meeting the approval, audit trail, and time stamping functions required in 21 CFR Part 11. | www.jdedwards.com |
| Matrix 10 PLM environment | The Matrix PLM Platform serves as the foundation for the overall Matrix 10 environment and combines an open, flexible Internet platform with extensive collaboration services, an array of adaptable development tools. The growing collection of software offerings provides proven product lifecycle capabilities - from concept and design through manufacture and ongoing service. | www.matrixone.com |
| PMX,MES, CTM, RDM, MQS | Propack Data a pioneer and visionary in the Manufacturing Execution System (MES) sector, Focusing on FDA/GxP-regulated industries such as pharmaceuticals, food-stuffs and cosmetics, Propack Data provides validatable standard software for the entire manufacturing and packaging processes in the field of supply chain execution under an ERP system. Propack Data's current release, PMX 3.1, satisfies the requirements of 21 CFR 11. | www.propack-data.com |
| MFG/Pro | QAD understands patient device tracking (PDT), serial traceability, and validation, and what these conditions mean up and down the business chain, from procurement to distribution and all points between. | www.qad.com |
| Revelink's Enterprise Executive | Revelink has developed a validated enterprise application development platform that enables developers serving regulated industries to build enterprise applications in 10% of the time currently required. Building with Revelink’s Enterprise Executive results in Enterprise Applications that are robust & scalable; are based on open software standards; use common enterprise repositories; and are 21CFR11 compliant. | www.revelink.com |
| mySAP ERP | Create of EBR after final completion of Production order, using documentation of process as well as of results of the process, including staged and identified Materials and reconciled material consumptions, EBR approval can be made mandatory for usage decision. Full support for 21 CFR Part 11 signature and record requirements. | www.sap.com |
| 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. | www.chemsw.com |
The above table lists all the Software identified by PharmOut Information Technology.
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