eInfo Tree, Enterprise series

Designed specifically to meet the regulatory requirements of the life science industries, the eInfotreeTM Digital Compliance solution is fully compliant with 21 CFR Part 11 requirements for Electronic Records and Signatures. eInfotree’s patent-pending Digital Compliance TM Architecture seamlessly integrates disparate "islands of information" into a regulated, controlled and compliant digital nervous system with single point access throughout the workgroup, department or enterprise.

FirstDocs

FirstDocs™ for GMP, a comprehensive prepackaged electronic document management solution in support of pharmaceutical manufacturing and quality processes. It's a part of our FirstDocs™ solution suite, which offers a set of services and software for research and development, case report form management, and regulatory submissions.

QSI System,

Designed specifically to meet the requirements of ISO 9001:2000, the QSi System for Quality Management helps your organization reap the benefits of ISO certification, including improved customer satisfaction and reduced costs.

LiveLink

ProofMark

ProofSpace, Inc. has designed ProofMark to perfect the electronic documentation process, withstanding audit and minimizing risk. ProofMark encapsulates what occurred, when it happened and includes who participated in the activity. In the Pharmaceutical industry, ProofMark aids companies to comply with 21CFR part 11 regulations.

DocCompliance

QUMAS DocCompliance® is a complete enterprise compliance application designed exclusively to manage the full lifecycle of regulatory controlled documentation. Organizations are assured of compliance with regulatory bodies' guidelines and directives. The risk of non-conformance is avoided through complete auditing and traceability on document history including event logs, audit trails and comprehensive reports.

ApproveIT

Meets FDA 21 CFR Part 11 right out of the box. ApproveIt from Silanis moves signature approvals on-line. Its native support for the most widely used document creation tools leverages your organization's existing communications infrastructure so you can continue doing business as usual, with little or no additional training.

InfoThehna,

Infotehna products and solutions for managing documents and records in the highly regulated pharmaceutical industry. my-Pharma™ consists of the pre-packaged solutions detailed below which cover the requirements of different business areas such as Regulatory Affairs, QA, etc. my-Pharma™ is based on my-Process™ a collaborative web environment developed on Documentum and is in line with 21 CFR 11 regulations.

TrackWise

Sparta Systems' TrackWise is a powerful system for tracking and managing: Problem Reports, Bugs/Defects, Change Requests, Customer Complaints, Corrective Action Items, Investigation Reports, Audit Observations/Findings.

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.

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.

Chemera

Chemera, inc. has developed proprietary software utilizing 128-bit encryption technology that fully complies with 21 CFR part 11 (FDA regulation).

Maximo

With MRO Software's vision and usable solutions, you can optimize performance. We have helped thousands of asset-intensive organizations; including all 13 of the largest pharmaceutical companies in the world.

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

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.

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.

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.

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.

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.

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