By Keith Morris,2014-04-23 07:19
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    1. ABB Advant Layered on to and designed to be integrated into the hardware packages is the

    expertise of ABB‘s Knowledge solutions. Continually evolving to meet the

    current and emerging standards important to the Pharmaceutical business,

    such as Electronic Batch Records based on 21 CFR part 11, or Batch Control

    Systems compatible with ISA S88.01 standards, ABB prides itself in

    providing the customer the optimized package solution for his current and

    future needs.

    2. Agile Software Agile Agile Software Corporation provides collaborative manufacturing commerce

    Corporation Anywhere? solutions for the e-supply chain. The Agile Anywhere? product suite allows

    supply chain partners to leverage the Internet and form virtual manufacturing

    networks for design control, product introduction, manufacture, and change.

    Agile Buyer? enables Internet-based demand aggregation, RFQ processes,

    and online procurement of direct (production) materials. Agile Anywhere is

    21 CFR Part 11 compliant for electronic records and electronic signatures with

    a proven validation methodology.

    3. Agilent ChemStation The system enables users to comply with audit and approval requirements

    Technologies, Plus such as 21 CFR Part 11.


    4. Aitken Scientific A-S Login A-S Login for Electronic Signature Compliance is a software product which

    Ltd. provides complete 21 CFR Part 11 compliant user login functions, and a

    comprehensive administrator console

    5. Alchemedia Mirage DALLAS, TEXAS January 9, 2002 Alchemedia Technologies,

    Technologies, Inc., a leading provider of Enterprise Digital Rights Management

    Inc. (EDRM) software, today announced the availability of Mirage

    Enterprise for pharmaceuticals, providing critical data currency and

    confidentiality functions for companies governed by FDA regulation 21

    CFR Part 11. Electronic documents, the subject of Part 11, are easy to

    copy and distribute, but copies are difficult to manage. The resulting

    rogue documents cannot be audited or updated, and therefore are

    violations to the FDA regulation. By controlling the saving, copying,

    forwarding and printing of documents, Mirage enables pharmaceutical

    companies, for the first time, to cut off rogue documents at the source,

    greatly reducing the scope of their exposure under Part 11.

6. Amersham UNICORN UNICORN Control System, version 4.0, is fully compliant with 21 CFR Part

    Biosciences Control System, 11. It is currently in use in many biopharmaceutical production processes

    version 4.0 approved by the FDA.

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    7. Analex Aside from merely understanding the 21 CFR Part 11 regulation,

    ecords_esignatures.html Analex has successfully developed Electronic Records and Electronic

    Signatures components, known as ESign?, for its own in-house

    software. Analex has also been invited to give presentations regarding

    Part 11 at medical device and pharmaceutical conferences. Using our

    experience and expertise, Analex can help your company become

    compliant as well.

    8. Ankersmid TOC Talk, Talk, Version 3.5 is designed to handle and manage TOC data and

    Version 3.5 ndex holland.htm metadata within the TOC Talk application in compliance with 21 CFR Part 11


    9. Applied Analyst? Analyst? software unites power and ease to set a new standard in Windows

    Biosystems SQL LIMS NT? platform-based data processing. Automated software routines rapidly

    and completely optimize the instrument for quantitative analysis. After data

    acquisition, the Quantitation Wizard quickly guides the creation of new

    quantitation methods. Queries, metric plots, configurable results table, and

    slide show mode provide fast and thorough data review. For regulated

    laboratories, you can easily achieve GLP compliance including the

    recommendations of 21 CFR Part 11 with comprehensive Security and

    centralized Audit Trail Manager. Analyst software provides flexible data

    acquisition, fast and easy data. SQL*LIMS? software is a complete

    laboratory information management system (LIMS) that gives you control

    over sample tracking, laboratory processes and workflow, data access and

    storage, and regulatory compliance. Supports your laboratory‘s compliance

    with the FDA‘s 21 CFR 11 Rule with dynamic security and regulatory

    compliance features

    10. Applied Statistics Applied Stats offers the most comprehensive tools available today to address the

    Inc. v4.4 SPC FR.htm security and data collection requirements posed by 21 CFR Part 11. Applied

    Stats v4.4 SPC software package incorporates a robust set of security options

    and policies that allow our customers to comply with these rigorous

    requirements and collect data with confidence.

    11. Aspen Tech Aspen Technology Inc. announced new software solutions that provide InfoPlus.21

    pharmaceutical and other regulated process manufacturers with a broad range and Batch.21; of solutions to comply with Title 21 of the Code of Federal Regulations. Aspen Alarm

    and Event;

    Aspen eBRS

    12. AssurX CATSWeb Are you concerned about Title 21 CFR Part 11 FDA regulations governing

    electronic records and electronic signatures? Don't be. The FDA edition of

    CATSWeb is fully compliant.

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    13. Automsoft Rapid-Pharma Automsoft's RAPID-Pharma is the first Plant Information Management

    International System to offer out of the box compliance with the specification, which will

    LTD enable companies to keep complete audit trails of their electronic records in a

    highly secure system.

    14. AVATAR LABTrack LABTrack incorporates a function called Electronic Signature that was

    Consulting defined by the United States Food & Drug Administration (21 CFR Part 11).

    Electronic Signature is a mechanism to accurately identify the user of the

    software at the time data is saved. It can do so using either controlled

    passwords or biometric devices like fingerprint readers. LABTrack supports


    15. QM6, Quality Log Book option now also includes an Electronic Signature feature. If the Beamex

    Manager m6_004.htm Electronic Signature is enabled, QM6 prompts for user id and password when

    Calibration a calibration is saved or approved.


    16. Beckman Coulter Pinnacle is the first CDS to be designed from the ground up to meet Part 11

    art11 requirements. Its Oracle* relational database and built-in security system

     ensure that no data can be deleted and that modifications are only performed

    by authorized personnel. 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.

    17. BioMedion INDexxis? is designed to manage data in accordance with predicate

    xis.html rules (GxP) and the new regulations on electronic records and

    electronic signatures, especially FDA 21CFRpart11.

    18. Blue Mountain Calibration Our flagship product, Calibration Manager? software, is among the world's

    Software Manager? leading calibration management database programs. Calibration Manager

    automatically calculates due dates, tracks histories and prints reports of

    calibration schedules. It also tracks preventive maintenance. Flexible data

    retrieval and reporting capabilities permit customization according to your

    exact needs. Password protection, audit trail and electronic signature features

    facilitate your validation process and ensure effective FDA record-keeping

    compliance. The electronic signature functionality was specifically designed

    to meet FDA 21CFR Part 11 requirements.

    19. Brendan StatLIA Brendan develops laboratory software to provide one complete standardized

    Scientific program for all immunoassay testing technologies. For automating workflow,

    the software is designed for easy interfacing and networking to any LIM

    system, instrument and PC. And all raw, computed and statistically analyzed

    data are organized, secured, and easily accessible. We believe that the less

    time spent processing, computing, validating, organizing, and troubleshooting

    data, the more time laboratories can spend using the data generated. 21 CFR

    Part 11 Compliant.

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    20. Cayenta Mainsaver's state-of-the-art, award-winning, Computerized Maintenance

    EAM ng/description.html - fda Management Software is used by companies both small and large to minimize

    operation costs and maximize productivity. Mainsaver is a total solution for

    Enterprise Asset Management (EAM). Mainsaver offers a robust Enterprise

    Asset Management (EAM) solution, professional consulting services,

    implementation and training services and now compliance to FDA‘s 21 CFR.

    11 so you can maintain your competitive edge.

    21. Charles River EndoScan-V EndoScan-V version 1.0.13 is the first endotoxin-specific software that

    Laboratories version 1.0.13 / addresses the 21 CFR Part 11 requirement for validation.

    22. Chemera Inc., inc. has developed proprietary software utilizing 128-bit encryption

    cryption.asp technology that fully complies with 21 CFR part 11 (FDA regulation).

    23. ChemScope eGMP eGMP is compliant with FDA regulations, including 21 CFR Part 11. And all

     through a single web browser! ? 24. ChemSW CIS Chemical ChemSW announced a new option for its CIS Chemical Inventory System

    that provides audit trail and electronic signature, for 21 CFR Part 11 Inventory ? compliance. The system incorporates multiple levels of security, transaction System

    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.

    Cimage Novasoft 25. NovaGMP NovaSoft, a global provider of eBusiness application solutions to

     s/newsreleases/prgmp0601.htm industry, today announced the release of NovaGMP. This product helps FDA

    regulated companies, such as pharmaceutical and medical device

    manufacturers, to comply with the FDA regulation 21 CFR Part 11 for

    electronic records and signatures. NovaGMP is part of the Cimage NovaSoft

    GMP suite, which is based upon Cimage NovaSoft's extensive pharmaceutical

    manufacturing and medical device industry experience. It enables FDA

    regulated companies to manage laboratory and processing information

    throughout its lifecycle, helping them to achieve the documentation, safety

    and quality standards required to comply with Current Good Manufacturing

    Practices (cGMP).

    26. Cimcon eInfoTree ? Designed specifically to meet the regulatory requirements of the life science Software, Inc. industries, the eInfotreeTM Digital Compliance solution replaces traditional

    paper-based regulatory data and processes and is fully compliant with 21 CFR

    Part 11 requirements for Electronic Records and Electronic Signatures.

    eInfotree‘s patent-pending Digital ComplianceTM Architecture seamlessly

    integrates disparate "islands of information" without affecting existing

    business processes into a regulated, controlled and compliant digital nervous

    system with single point access throughout the workgroup, department or


    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    27. CIMTechniques, The FDA has now started aggressive enforcement of 21 CFR Part 11, which is CIMScan

    Inc. the regulation regarding electronic records and electronic signatures.

    CIMScan now contains all the necessary functions and capabilities to insure


    28. Client Solutions Silverstream

    V2.5 sen.shtml The system was implemented within spec, within budget and on-time.

    Change requests are now being processed more efficiently and with greater


    Users know where their request is, what is its status and who is holding it

    Janssen have successfully removed the paperwork from the change control


    The system is compliant with FDA regulation 21 part 11

    The system is currently being used by fifty staff members and can be deployed

    further at zero cost

    Because the system is intranet based, changes or ammendments can be made

    at server level and deployed immediately

    29. Clinsoft Clintrial Clinsoft Corporation is the world's largest provider of clinical research

    Connect ? systems. Market leadership and innovative technology position Clintrial? as

    Clintrial ? the industry-standard information platform for biopharmaceutical and related

    Clintrace ? industries. Clinsoft's information platform enables companies to focus

    Integrated development resources on product "winners" sooner and has brought more

    Review ? pharmaceutical products to market than any other software platform.

    Jreview ?

    30. ClinSource TrialXS / TrialXS / EDC complies with FDA 21 CFR Part 11 regulation

    EDC and conforms to GCP guidelines.

    31. Cognex In-Sight ? Corporation (NASDAQ - CGNX), the world's leading supplier of

    news-compliance.asp machine vision systems, announced that its In-Sight ? family of networkable

    vision sensors are compliant with the U.S. Food and Drug Administration's 21

    CFR Part 11 regulations. Cognex Corporation designs, develops,

    manufactures, and markets machine vision systems, or computers that can

    "see." As part of its compliance initiative, the company has authored and

    published detailed Application Guidelines that provide recommendations for

    developing 21 CFR Part 11-compliant automation projects, which incorporate

    machine vision technology.

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    32. Communication Sign IT Provide electronic signature software. Communication Intelligence Intelligence Corporation (CIC), provides input, security and electronic signature offerings Corporation to Enterprises, OEMs, integrators, Asps, Strategic Partners and End Users.

    (CIC) 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.

     ? Compliance Software Solutions Corporation (CSSC) has developed the 33. Compliance EMSS?Environmental Monitoring Software System (EMSS) to comply with the Software

    requirements defined in the FDA‘s 21 CFR Part 11 for Electronic Documents Solutions Corp.

    34. Computer EFLEXION A revolutionary, powerful monitoring tool, EFLEXION fully automates the Compliance, Inc. tasks of process data management. E-Flexion automates every step, every

    task, in quality information management. Manual data handling is eliminated,

    saving considerable time and freeing people for higher level, strategic use.

    Human time can be spent interpreting results and taking action.

    Comprehensive in operation, analytical abilities, and features, E-Flexion

    gathers, analyzes, and delivers all the information you need. Data is collected

    and analyzed around the clock from any piece of equipment, for any desired

    analysis. Everything from production data to run comments is stored in a

    complete record.

    Built for compliance from the ground up, E-Flexion meets strict federal

    regulations for electronic record keeping, including requirements of FDA

    21CFR Part 11. An internal audit log -- with assigned access privileges --

    tracks any changes made to any records in the database repository. Repository

    data cannot be deleted. Data transfer from collection to repository is error-free

    and fault-tolerant.

    35. ConsenSys MedDev has been specifically designed to meet the requirements ConsenSys

    Software s/02ourprod/02c.cmdds.html of the Part 11 rule, which dictates the accepted use of electronic signatures and MedDev

    Corporation electronic records. ConsenSys MedDev ensures that every release or revision

    of a part or document has associated with it one or more reviews or change

    orders. These work records in turn contain the signatures, comments, and

    justification records for the release or revision. This web of related records

    forms a cohesive audit trail that completely addresses FDA/ISO requirements.

    36. Creon Q-DIS/R The extended use of computer technology and the increasing automation in

    the field of modern chemical analytic, produces large quantities of analytical


    In consideration of:

    • the diversity of data sources

    • GLP and GMP guidelines

    • governmental requirements (FDA 21, CFR Part 11)

    • company objectives

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    Wireless? Patient-generated data entry via a wireless or handheld device

     Edit checks to diary data before entry into trial database

     2-way communication between clinical R&D stakeholders

     Diary page amendments during the trial conduct

     Multiple languages and technology platforms in the same trial

     Flexible generation of reminders and alerts to patients, based on the

    cumulative history in the trial

     Interface to the major clinical data management systems with industry-

    standard XML

     High level of security based on PKI (Public Key Infrastructure) digital

    signature technology

     21 CFR Part 11 compliance

    38. CSEngineering CIWOS CSEngineering AG has software called CIWOS that is 21 CFR Part 11

    AG compliant.

    39. Cyber-SIGN Inc. Cyber-SIGN Cyber-SIGN and Biometric Dynamic Signature Verification

    Cyber-SIGN?, we are a leader in the area of on-line enterprise user

    authentication utilizing biometric dynamic signature verification technology.

    With Cyber-SIGN, using handwritten signatures, on-line identity is securely

    authenticated and a trusted electronic signature is created. Our technology is a

    simple and natural biometric system that increases data security and enables

    trusted document authorization. We analyze the shape, speed, stroke order,

    off-tablet motion, pen pressure and timing information captured during the act

    of signing. The captured values are unique to an individual and virtually

    impossible to duplicate.

    40. Daon DaonEndorse 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.

    41. DataMirror LiveAudit provides real-time data integration software that helps companies

    enter ensure cost-effective compliance with FDA Regulation 21-CFR Part 11.

    LiveAudit? for DataMirror Transformation Server enables FDA-regulated

    companies to create real-time audit trails that preserve historical information

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    42. DataSweep DataSweep Datasweep, Inc. provides collaborative solutions for the medical industry to

    establish a paperless GMP environment that is compliant with 21 CFR Part

    11. Datasweep's solutions leverage the Internet to give medical OEMs and

    their partners the Web visibility into and control of real-time manufacturing

    and quality information to drive improvements in planning, manufacturing,

    record archiving and product lifecycle management, while driving down the

    total cost of compliancy.

43. DataTrak Datatrak EDC CFR21;Part 11 Compliant - Contact us for a document with details. Audit

    International Trail: When you compare EDC product you'll find DATATRAK's Audit Trail

    to be the best of breed. DATATRAK EDC gives you an audit trail down to the

    data field unlike many systems that give you a snapshot at each page turn

    (roughly equivalent to filling out a CRF with a pencil). This also means that if

    the Investigator loses a communications connection, they do not lose data.

    44. Datastream Datastream 7i delivers security for electronic records and signatures and is able

    21cfr11.asp to meet the individual needs of various companies who have to deal with 21

     CFR 11 concerns.

    45. DatumEBusiness TrustedTime Trusted Time is a solution for providing the necessary components to meet the

    Solutions e-business need for secure and non-repudiatable time stamps. It is comprised

    of two main concepts: the security of the time stamp and the auditability of the

    time stamp. The security aspect addresses both the transmission of the time

    from a National Measurement Institute to the local time stamp system and the

    protection of time and audit information within any of the systems that the

    time stamp may reside in along the way. The audit nature of Trusted Time is

    the storing of time source and cryptographic information within each time

    component and the PKIX-compliant time stamp itself.

    46. Deadline EDS 1999, DSI envisioned a system that would allow companies to easily

    Solutions Inc. (Electronic iEDS.htm define a “process” with a tool that was easy and quick to use. By

    (DSI) Documentation using this tool, an entire process could be defined and then an

    System) “electronic batch record” could then be readily extracted. All of this

    was done with the goal of helping companies who are committed to

    meeting the 21 CFR Part 11 Specification do exactly that.

    47. Decision ProcessPro Decision Management International, Inc. develops leading-edge software for

    Management FDA regulated industries. The integrated solution set includes a robust

    International 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


    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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    48. Dionex Chromeleon New Electronic Signature and Signoff feature provides electronic signatures in Corporation conformance to FDA's 21 CFR Part 11 rules. Unique signoff levels allow

    users to submit, review, and approve electronic records from CHROMELEON

    efficiently and completely.

    49. Docent Docent explicitly designed Docent Enterprise to enable pharmaceutical

    Enterprise 21CFR11.html companies to meet the United States Code of Federal Regulations, Section 21,

    Part 11 requirements of managing Electronic Records and Electronic


    Docent's specific features supporting 21 CFR Part 11 include:

    ; Secure role-based system access control

    ; Guaranteed unique non-reusable user accounts

    ; Comprehensive data management and retrieval including encrypted

    storage and network access

    ; Electronic signatures consist of unique user ids and an encrypted


    ; Biometric hardware/software authentication support

    50. Document MASTERContr MASTERControl regulates secure access to documents and other electronic Control Systems, ol files created in any software application. MASTERControl FDA Edition was Inc. written to address stringent security requirements for FDA companies. This

    includes both the enhanced features needed to comply with these standards

    and assistance with the on-site validation process.

    51. Documentum/PriGMPharma GMPharma is the first enterprise-wide solution that offers an out-of-the box e-

    cewaterhouseCoo business platform for global content management of GMP regulated pers documentation. Conforming to 21 CFR Part 11 requirements, GMPharma cuts

    operational costs, accelerates transfer times from development to

    manufacturing and improves GMP compliance.

    Standard functionality includes electronic signatures, audit trails, controlled

    printing with overlays and watermarks, automatic version control,

    preconfigured life-cycles and role based viewing models. Additionally,

    GMPharma includes deployment packages that accelerate implementation,

    streamline validation and manage document migration. TM DocWave provides Life & Health companies with high level consulting 52. DocWave QualWave

    services and business solutions. Compliant with pharmaceutical good ?practices, FDA and International regulations, QualWave is a complete

    solution for managing Quality Documents, (integrating 21CFR part 11 rules). ?QualWave is a part of our " Wave " business solutions suite for the R&D,

    QA, Manufacturing, Distribution and Marketing Departments of

    Pharmaceutical, Cosmetic and Food Companies

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

    No Company Product(s) URL Claim

    53. Doxis SCCM Doxis and 21 CFR Part 11 Compliance

     Allows you to keep process records (required by GMPs) securely and in strict

    compliance with 21 CFR Part 11

    Has been designed to ensure record authenticity and integrity - features are

    carefully crafted to provide:

     Strict control of user access, and of permitted user actions by role

     Accurate and easy date retrieval for authorized users

     Automatic audit trailing of data entries and user actions

    Provides options for biometric (handwritten) and non-biometric electronic


    Automatically stamps all data entries and signatures with date, time, and user


    Binds all e-signatures to their records, so they cannot be excised or copied

    54. DSI dsiEDS Deadline Solutions, Inc. delivers high quality Client/Server and Internet SCADAeds enabled applications that will provide 21 CFR Part 11 Compliance for the

    Food and Drug Industries.

    DSI's Electronic Documentation System (dsiEDS) is a Rapid Application

    Development tool that is used by our staff to quickly create a

    'Manufacturing/Production Process' or map functionality to a given piece of

    process equipment. Any given piece of data can then be selected as passive or

    required to have an electronic signature to ensure compliance.

    DSI's SCADA Electronic Documentation System (SCADAeds) takes the best

    features of dsiEDS and ties it to the pharmaceutical industry's most popular

    packaging line hardware. SCADAeds currently works with Ramsey

    AC4000/AC9000 checkweighers, Lakso Fillers, Omega Unscramblers, and

    Fowler Cappers.

    55. DUII LIMS DUII develops and markets its products and services of laboratory information

    management system (LIMS), 21CFR11-aware computational infrastructure,

    and Standard Operating Procedure (SOP)-driven networks. These satisfy the

    requirements of 21CRF11 by authority check, operational system check,

    device check, SOP, electronic signature and closed systems. DUII creates

    tools to enhance communication and to enforce compliance.

    Original compiled by Serentec, Inc. (919) 831-1166; modified by FDA Office of Enforcement. Revised 1/28/2002

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