Software
Electronic Signatures Electronic Records 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.
ERES Software:
| Vendor | Claim | Website |
| A-S Login | A-S login provides complete 21 CFR Part 11 compliant user login functions, and a comprehensive administrator console. The software uses complex encryption and checksumming techniques to protect data from accidental or deliberate falsification. | www.aitken-sci.co.uk |
| EBR | Siemens has continued to lead the competition in 21 CFR Part 11 with numerous installations in the pharmaceutical industries. Those installations include the creation of one of the first paperless pharmaceutical manufacturing facilities specifically designed to meet the requirements of 21 CFR Part 11. | www.sea.siemens.com |
| SmarTeam for FDA kit | SmarTeam for the FDA solution provides your company instant compliance with the technical requirements of FDA Regulation Rule 21 CFR Part 11 and facilitating compliance with the procedural control requirements. | www.smarteam.com |
| CompasSoft Enterprise | Compassoft’s powerful automated tools for managing the unrecognized risks your company faces every day. Compassoft's software discovers, validates and controls masses of information, keeping you in compliance with regulatory mandates such as Sarbanes-Oxley and the FDA's 21 CFR Part 11, and reducing the risks of accounting errors and fraud. | www.wimmersystems.com |
| Sign IT | Communication Intelligence Corporation (CIC), provides input, security and electronic signature offerings to Enterprises, OEMs, integrators, Asps, Strategic Partners and End Users. And by making possible the legally secure electronic signing of documents anywhere at any time, CIC leadership is a prime mover of businesses toward a paperless world. | www.penop.com |
| DaonSign | Biometrically secured electronic signing capabilities for the Pharmaceutical Industry. Daon's e-signature solution adheres to Worldwide Regulations & Legislation around the use of electronic signatures. | www.daon.com |
| Gould-PoNeMah P3-Plus | The P3-Plus Data Security Option utilizes a ‘Smart Card’ for each user. These smart cards are initialized with unique encryption Public/Private Key set for digital signatures. Files can be electronically signed using the operator’s electronic signature. | www.lintonist.co.uk |
| CyberLAB | CyberLAB™, is designed to help you achieve 21 CFR Part 11 compliance, with features like CyberLAB's Electronic Signature plug-in. Utilizing Adobe Acrobat, an industry-standard technology, CyberLAB lets you electronically sign documents, placing an encrypted signature within the document and an unalterable "watermark" on the page indicating the signatures validity. | www.micromass.com.uk |
| Q&MIS | Pilgrim's Electronic Signature component provides the necessary controls for each electronic signature to be unique to each individual. | www.pilgrimsoftware.com |
| Tamarin Integrity Server | The Zolera Tamarin Integrity Server protects critical information assets and essential online business processes with digital signatures and encryption. It is designed to conform to regulations and best practices associated with information integrity, such as the 21CFR11 FDA regulations | www.zolera.com |
| CoreDossierX | CoreDossierX Features can be used alone or in conjunction with your document management system Audit trail capabilities support 21 CFR Part II compliance on a per publication basis, Enables the assembly of smaller publications that feed into larger submissions. Automatic finishing options: table of contents generation, cross-references, headers, footers, watermarks and pagination schemes. | www.liquent.com |
| Self-sign | The digital signature solution that is provided with the full acrobat package is called “self-sign”. This solution is 21 CFR Part 11 compliant and will provide an immediate solution to using electronic signatures with minimum investment and minimal impact on legacy systems. | www.malvern.co.uk |
| 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. | www.aspentech.com |
| 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 | www.processpromfg.com |
The above table lists all the Software identified by PharmOut Information Technology.
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