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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Q&MIS

Pilgrim's Electronic Signature component provides the necessary controls for each electronic signature to be unique to each individual.

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

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.

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.

TrendReader Standard Data Logger

ACR Systems TrendReader Standard Data Logger Software, includes data validation that permits our software and hardware to conform to the FDA’s 21 CFR Part 11 regulations. Data viewed on either the PC or printed form is authentic by providing a data file sign-off mechanism, a CRC check (Cyclic Redundancy Check) for data integrity, and an overall data validation pass/fail statement with sign-off right on the graph.

EMSS

Compliance Software Solutions Corporation (CSSC) has developed the Environmental Monitoring Software System (EMSS©) to comply with the requirements defined in the FDA’s 21 CFR Part 11 for Electronic Documents

Validator 2000 LabWatch

The Validator 2000 meets all the new FDA regulations for thermal validation, including 21 CFR Part 11 on electronic signatures and records. It provides many time-saving benefits such as automating sensor calibration and report generation. The LabWatch System operates in compliance with the FDA regulation on 21 CFR Part 11 Electronic Signatures and Records

Inspection Manager

TISCOR designs software for hand-held computers for technicians performing site and equipment inspections. TISCOR solutions prove compliance and prevent the falsifying of records. Among TISCOR's many products is Inspection Manager, which effectively addresses 21CFR Part 11

UNICORN Control System,V4.1

Unicorn Control System version 4.1 was audited in May 2001 and was found to fully conform to all current and relevant US FDA guidelines and regulations including 21CFR part 11.

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.