Solution Providers
Computer Security Software and Consultants
To add a solution provider, go to our Submission Page
Alchemedia
Alchemedia, a leading provider of security solutions, prevents the loss of
proprietary information. Mirage software ensures control of information,
providing data confidentiality and data currency. Mirage protects against
the loss of sensitive and proprietary material by preventing copying,
saving, printing, forwarding and screen capturing of documents. By
managing duplication and printing, Mirage enables pharmaceuticals to
prevent unauthorized and rogue copies, greatly reducing the scope of their
exposure under Part 11.
Amaral
Group
The Amaral Group, LLC provide one-stop shopping for all the security you
need to design, implement, maintain, and support network infrastructure
and e-commerce sites. Our solution-based approach includes in-depth looks
at components such as scalability, performance, hosting providers, data
warehouses, and help desks. In addition, we provide the following specific
services: Requirement Analysis, Security Audit/Assessment, Intrusion
Detection, Policy Management, Product Installation, and Implementation
Security Monitoring.
Ambiron
Ambiron is an independent information security advisory firm providing
enterprise information security solutions to large and mid-sized
businesses. By combining industry-certified experts with best-of-breed
technologies, Ambiron develops and delivers cutting edge solutions that
mitigate risk and enhance the bottom line.
Aporia
Solutions
Provides proven IT security solutions, audit & assessment services to
banks, financial institutions and other companies. Aporia compliments your
staff ‘s skill and experience for FFIEC compliance IT Assessment, GLBA
Security and Privacy Compliance, Penetration Tests, Vulnerability
Assessments (Internal, External, Wireless), Security Policy, Security
Awareness Training, Password Security, PIN Security Compliance, Continuity
Panning and other related security and IT services.
Ascent
Solutions
ASCENT SOLUTIONS, Inc. (ASi), the developers of the QuantaMail service, is
a ten-year-old privately held software developer and reseller, promoting a
full line of cross-platform compatible programs for the AS/400, DOS, Mac,
MVS, UNIX, VM, VMS, VSE and Windows environments. ASi is proud to be an
Inc. 500 Company and is listed as a Deloitte and Touche Technology Fast
500 company.
AVSquare-NS3 India
AVSquare-NS3,India's one-stop source for all the security you need to
design, implement, maintain, and support network infrastructure and
e-commerce. providing a variety of Internet & Networking Management &
Security Solutions & Services, including Requirement Analysis, Security
Audit Assessment, Intrusion Detection, Policy Management, Product
Installation, Implementation Security Monitoring, Virtual Private
Networking etc...
BrickRed Technologies
We are among the leading Offshore Software Development Companies in India
offering custom offshore software development, offshore programming, smart
card applications, custom application development, outsourcing product
development and database programming.
Cognicase
Cognicase has 5,000 technical experts in the Pharmaceutical sectors.
Offices
in US, Canada and Europe. In IT/IS business over ten years. Offering IT
services allowing companies to fulfill commitments to 21CFRPart11
environment, from consulting to complete near-shore outsourcing. We
provide
full solutions, enabling optimization of your 21CFRPart11 projects.
Consul
CONSUL risk management provides IT security audit and administration
products and services for Global 2000 companies and organizations.
CONSUL's line of administration products streamlines the management of
security in mainframe environments. CONSUL's line of audit products
monitors and audits every event within a company's mainframe and networked
IT environments, enabling its clients to develop the most secure operating
environments possible. CONSUL's clients include Kroger, The New York
Times, AT&T, Blue Cross/Blue Shield, Fortis and many other globally
recognized companies. Founded in 1986, CONSUL is headquartered in Delft,
the Netherlands, with subsidiaries in the United States, Germany and
Denmark and 22 sales offices around the world.
Crash
Course Software
The Lock 98 is a high-security, high-end system-protection program for Windows 95. The password protection is multilevel so that administrators
can define different settings for multiple users or maintain a global security
scheme depending on their needs. Options to secure the Windows interface
go far beyond most comparable utilities.
DAON
Daon is a biometric identity management company offering a unique and
integrated approach to meeting the challenges of enterprise security. Daon
protects an individual's privacy while ensuring non-repudiation and
operational and security risk efficiencies. Daon delivers a highly
scalable and robust technology infrastructure to organizations in the
Financial Services Sector, the Government & Security Sector, the Travel &
Transport Sector and the Pharmaceutical & Life Sciences Sector. Daon
offers the pharmaceutical industry a software solution that enhances
security and compliance at every step of the drug development and delivery
process. Daon utilizes biometric technology to enable highly secure
collaboration across the value chain, provide positive and auditable
authentication throughout the R&D and manufacturing process and meet
regulatory requirements (such as those outlined in 21CFR Part 11) for
non-repudiation and data protection.
Datum
Trusted Time is a secure time stamping solution with an evidentiary trail
to a National Measurement Institute. It can ensure that the time stamp
used by a transaction, digital signature, or computer log is secure and
auditable. Trusted Time provides a very strong trust operation for time
integrity and the legal acceptance of the "when" of an
electronic event.
Delphi
Consulting
Delphi Consulting (DCG) is a regulatory writing service that works with
clients for electronic documents, i.e., GMP SOPs and procedures. We
provide FDA release to market and FDA required GMPs and process procedures
to medical device manufacturers.
Digistamp
DigiStamp provides a Trusted Time Stamp solution like an electronic notary
for proving records integrity. DigiStamp’s secure trust model combines the
digital “fingerprint” of an electronic file with a trusted time stamp and
a digital signature. That time stamp provides the values of
non-repudiation, data integrity, authentication and trusted time. The data
files remain secure and confidential within the users environment.
DigiStamp offers a JAVA based desktop GUI and an API Toolkit.
Dimension
Consulting
Dimension Consulting offer a Change Management tool for SAP systems to
control changes to GMP transactions. Each transaction has it's own set of
authorization profiles that are enforced through workflow.
Disaster
Recovery Associates
Disaster Recovery Associates develop and provide business continuity
planning software, as well as maintaining the Disaster Recovery Directory.
The product range covers all phases, from business impact analysis to
testing of the plan itself.
DMS
Technologies
DMS provides security solutions for the life science and healthcare
industries. One of our unique solutions is a secure information transport,
storage and management platform that surpasses the boundaries,
complexities and deployment issues of conventional email, PKI, VPN's and
firewalls. We also provide a robust eLearning tool that helps address the
training requirements outlined in HIPAA. Our courses are developed by
leading HIPAA experts and are available 24 x7 via the Internet.
E-Lock
Technologies
E-Lock Technologies is an Assurance Management company that develops and
provides complete Information assurance to e-business content and
transactions to meet emerging Internet, extranet, and intranet business
requirements. Using PKI based Digital Signature technology; E-Lock's
products encompass capabilities of Digital Signatures, Verification,
Encryption, Decryption and Validation to validate and certify the source
of data, assure that the data is not tampered with and limit access to
authorized users only.
EnsureLink
EnsureLink is a Managed PKI services provider. EnsureLink’s
Managed PKI services enable Pharmaceutical and Biotechnology companies to
control their online information securely, privately, with the highest
levels of authentication, and access control. EnsureLink’s solution is
compliant with the 21 CFR Part 11 law concerning data security and digital
signatures.
eTrue
eTrue’s products and services represent the next generation in computer
network authentication and document management. PassMD is the cornerstone
of eTrue’s product suite, transforming authentication management into a
bottom-line contributor by reducing costs and increasing workflow
efficiencies for the healthcare, biotechnology, and pharmaceutical
industries. eTrue also provides digital signature of documents with the
author or editor’s biometric data, guaranteeing irrefutable
authentication.
Fyrplus
Fyrplus is a consultant company based in Sweden which works with
Medical Technology Solutions Development. One area of development is
system solutions regarding compliance to '21CFR part 11' . Fyrplus has
worked in particular with systems related to pharmaceutical production,
and have used biometric techniques in our solutions.
Hollis
Group
The Hollis Group is a provider of IV&V (Independent Verification and Validation)
services, technology training, and designated engineering representative
services for your mission critical information systems projects. We
specialize in regulated industries, particularly bio- pharmaceuticals,
medical devices, and healthcare.
Indyzen Inc
US based Indyzen Inc offers application and web software outsourcing
services through its Indian sister concern CompIndia, and can save
significant amount of money for you through outsourcing.
Information Security Corporation
ISC has focused on the design and development of standards-compliant
public key encryption and authentication software since 1989. Our
products have been adopted and are widely deployed by the most
security-conscious federal intelligence and law enforcement agencies, as
well as by many large corporations.
InfoStrength
InfoStrength has a proven track record of designing and implementing
web-based business applications that address information needs driven from
operational processes, regulatory requirements such as FDA 21CFR Part 11,
and HIPAA, and quality standards such as IS0 9000 and GxP practices.
InfoStrength provides a unique blend of business, regulatory, and
technology expertise to meet the needs of the Pharmaceutical, Healthcare,
Biotech, Clinical Research, and Manufacturing industries.
Infrasafe
Infrasafe is a global security design and integration firm headquartered
in Orlando, Florida. With over 35 years of high-level security industry
experience, Infrasafe is respected worldwide for developing proactive
solutions to some of the world’s toughest security challenges. Infrasafe
serves clients from both enterprise and government markets.
INS
Counsel for organizations that seek to successfully resolve security
issues that impact profitability. Member, High Tech Crime Investigation
Association.
Integic
Offering: CRF WorkManager automates the core of clinical, therapeutic, or
device trial processes using sophisticated document processing and
offering access across multiple geographic locations. It electronically
distributes work to data reviewers e.g. CRAs, data entry staff, medical
writers. It has features to integrate with all major clinical databases
and it provides variety of technologies for taking global clinical trial
management on-line.
IQS
IQS is a full service biometric company providing complete hardware and
software solutions. Fingerprint authentication products. We design,
develop and markets authentication technology enabling secure and
convenient access for IT, Intranet, Internet, and other applications.
Access is controlled by fingerprint, offering far more convenience, lower
administrative costs and greater security than traditional password or
PIN-Codes controls. IQS product line includes: Fingerprint physical access
unit, Time and attendance systems. Fingerprint based Mouse including
Special software's , ActiveX , Dll's to implement in any HMI , MMI Factory
application.
IT'sQA Ltd
IT’sQA (London, UK) is a network of collaborators well versed in the
regulatory requirements for clinical research, quality assurance,
electronic records, computer systems, IT security, data handling and
statistics. We have a QMS compliant with ISO 9001:2000 and work together
to deliver outstanding quality assurance services to pharmaceutical and
biotechnology industries, Our clients include sponsors, CROs, software
development companies and other institutions involved in clinical
research.
Lemon
Planet
Lemon Planet develops software components and provides services for
customers with high requirements on access, security and collaboration.
The product suite, Lemon Planet Mobile Framework, supports the three A's,
Authentication, Authorization and Audit. The products also features multi
channel support (Web, PC, PDA's etc) and a centralized management tool.
Mojo
Commerce
MojoCommerce combines traditional quality, regulatory and compliance consulting for FDA-regulated businesses with extensive expertise in how FDA-regulated
organizations can leverage information technology to improve
both compliance and profitability. We specialize in validation, quality system and procedure development, 21 CFR Part 11 compliance assessments and infrastructure upgrades and compliance technology solutions.
NET2S
Group
NET2S Group is a leading international consulting and engineering firm
specializing in communication technologies (networks, systems
infrastructure, software solutions, security) for business-critical
environments. Our clients are Global 500 companies operating in highly
regulated industries such as Banking and Finance, Pharmaceuticals,
Insurance, Energy, Telecommunications, and Transportation. With our
comprehensive understanding of communication technologies and the business
environments our pharmaceutical and healthcare clients operate in, we can
assist with education and compliance regarding 21 CFR 11 and HIPAA.
Network Infrastructure Technologies,
Inc.
N.I.T growing list of stellar references is a testament to our customer
service, forward thinking and problem-solving skills.We utilize only proven,
superior products to develop state-of-the-art systems. N.I.T focus on
minimizing the need for ongoing service, QA and Validation needs. Our
relentless pursuit of customer satisfaction means that we provide only the
best compliant regulatory computer networking solutions for our valued
client based in New York.
New World Design
New World Design is a systems integration & computer security consulting
firm. We understand the problems involved with complying with 21 CFR Part
11; we have helped several firms implement the required systems &
software. Using our own structured engagement model, we are successful in
helping organizations implement systems to ensure the integrity of their
medical records. Health care providers, pharmaceutical, & biotech firms
can reduce their exposure to security threats using our services.
Novaforge Total Security
One source for total security: Novaforge manages the complex total
security problem. We help life science companies meet challenges in:
business continuity, privacy, intellectual property protection, and
compliance. Meeting challenges in physical, cyber, & human security at a
lower cost; with better executive awareness, insight, control, and command
of total risk --we maximize your Security ROI and ensure there are NO WEAK
LINKS in your security chain! We are happy to discuss your security
concerns and share best practices. Please email us to arrange a phone
meeting and security appraisal.
Pedestal Software
Pedestal Software provides security management software that enables
organizations to quickly and cost-effectively audit, deploy and enforce
system security policies across the enterprise. Our solutions include
SecurityExpressions for comprehensive security policy management and
administration; Intact for real-time monitoring, reporting and remediation
ensuring policy compliance and system integrity; and NTSEC for changing
and administering system security settings.
Pentasafe
Security
PentaSafe Security Technologies, helps companies safely grow their
businesses by providing complete security policy and infrastructure
solutions that address security from a people, policy and technology
perspective. PentaSafe offers security software solutions for companies of
all sizes, including policy management, auditing, vulnerability
assessment, host-based intrusion detection, and best-practice security
publications.
Pharmaceutical
Training Institute
Pharmaceutical Training Institute (PTI) is a unique provider of
technical and regulatory professional training, PTI helps pharmaceutical,
biotech, and medical device professionals sharpen professional skills in
both pre-clinical and clinical areas.
Praxis Life Sciences
Praxis Life Sciences excels in Planning, Development, Documentation, &
Deployment (PD3) in regulated environments. Our associates have been
involved with all aspects of validation under FDA guidelines and
regulations including GMP, GLP, GCP, Computer Systems Validation (CSV),
and 21 CFR Part 11.
Protegrity
Protegrity's Secure Data cryptographic and selective database protection
and key management software solution enables companies to get quick and
easy compliance with the new information-privacy legislation such as the
Food and Drug Administration 21 CFR Part 11 regulation concerning data
security and digital signatures, the Healthcare Insurance Portability and
Accountability Act (HIPAA), the U.S. Gramm-Leach-Bliley Act (Financial
information), EU Safe Harbor, and the new VISA USA Cardholder Information
Security Program requirements.
Raskasky
Group
The Raskasky Group is dedicated to providing quality services to the
pharmaceutical industry. Featured are Computer System Validation: Support
Services, General Support Services , Computer System Validation: Seminars.
If you would like to receive a printed copy of our available services
please see the form on our Contact page.
Runnel Brool
Running Brook Consulting can help you to better understand and solve your
business information security needs. You need someone who can help you
sort through your business security needs and help prioritize them based
on real risks and vulnerabilities, help you create a winning strategy that
will allow you to create a proper level of security for your business and
your customers.
SafeStone
Technologies.
SafeStone Technologies PLC is a global leader in security systems
management providing organizations with secure access controls across the
extended enterprise, enabling effective management and compliance of the
corporate IT and e-business infrastructure. SafeStone solutions are
enterprise-wide providing policy compliance, auditing facilities,
vulnerability assessment, intrusion detection, user access management and
web access control. Developed from over 15 years of specialized experience
in the IT security marketplace, SafeStone’s solution suite is comprised
of the award-winning DetectIT for the iSeries 400 and AxcessIT which
delivers secure access and web-based control for the enterprise.
SealedMedia
SealedMedia provides a Document Sealing solution that seals confidential
documents against Digital Leakage. Only authorized users can use sealed
documents but cannot abuse them by redistributing them to unauthorized
users. The right to use sealed documents can be revoked at any time, even
from previously authorized users and regardless of the final location of
the sealed documents. SealedMedia supports standard document formats
(e.g.: email, Microsoft Word, Excel, PowerPoint, PDF and HTML)
SECARDEO
SECARDEO provides IT security consulting and solutions. We offer PKI and
advanced digital signature solutions. Our PDF signature solution has been
integrated for a leading medical systems manufacturer in order to fulfill
FDA 21 CFR part 11 requirements.
Security
Policies & Standards Group
The Security Policies & Standards Group provide information security
policies and delivery mechanisms. These include static MS-Word based
policy sets as well as interactive intranet based systems.
Sentry
Software
Armored Access Computer Security is just what you need for protecting your
computers against unauthorized access and PC viruses. It's iron-clad protection secures both stand-alone and networked PCs alike, yet it
remains simple and easy to use. Designed for PC's running DOS, Windows 3.x,
Windows 95 and Windows 98, Armored Access allows you to precisely control access
to files, directories, folders, drives, modems, printers, serial ports and
parallel ports. And with features ranging from C2 Security to
Single-Login, you have great flexibility in the amount of protection you can apply to
your PC's.
SeyMoor Technologies
SeyMoor Technologies concentrates on providing security solutions and
services, across all industries. We focus on the small to medium sized
companies & government agencies, where our dedication to technology,
operations, business continuity and management can continually produce
best practice, best-of-breed, cost-effective solutions. We provide these
solutions while keeping absolute independence, integrity and neutrality.
Our aim is to give you a gateway to secure business.
Shreyan InfoTech (P) Ltd. India
Shreyan Infotech, Mumbai India based IT Security company, offers Total
IT Security Services & Solutions including Secure Content Management,
Virtual Private Networking Firewalls, encryption, authentication, Remote
Access systems, Public key infrastructure, Security Assessment & Audit,
Information security policy procedures development, and business
continuity planning, Training
Silanis
Silanis Approve It meets FDA 21 CFR Part 11 right out of the box. Silanis
moves signature approvals on-line without additional hardware, software or
programming. 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.
Smarttech
The current management team has spent a total
70 working years in major blue chip companies. Comprehensive experience of
securing Windows NT and Windows2000 systems especially for 21 CFR part 11
compliance in the Pharmaceutical Industry. Systems installed have recently
been satisfactorily inspected by FDA.
St.
Bernard Software
St. Bernard Software offers a wide range of solutions that maximizes
product performance, security and management for your e-Business
applications utilizing Windows NT/2000 and NetWare.
TatvaSoft
TatvaSoft is a Software Outsourcing, Offshore Outsourcing Software
Development Company provides custom application development, e-commerce
management, content management, image formatting, search engine
optimization, web designing & development using cutting edge Microsoft .NET
Technology such as ASP.NET, VB.NET, C#, MS SQL SERVER 2000, XML, Crystal
Reports, QT etc.
Tatum
CIO Partners
Tatum CIO Partners is a national partnership of career Chief Information
Officers providing innovative CIO services to emerging companies,
middle-market companies, and large corporations.
Truelogic Solutions Pvt. Ltd.
Truelogics is a growing Software Consulting company with its head office
in Milton Keynes, UK and offshore development centre in India providing
.Net based custom IT Solutions.
Trustwave
TrustWave offers unparalleled expertise to help clients make the right
security decisions. We work with all kinds of clients; from small business
owners to Fortune 100 corporations, bringing together the best talent in
the industry for assessment, architecture, deployment, managed services
and training. Whether you are just starting to develop an Information
Assurance plan or are deploying a complex security solution, TrustWave can
work with your company to ensure success. 410-573-6910 ext. 2638.
T. W. Boris Associates
Validation recruitment services to the cGMP pharmaceutical business.
Engineers, chemists, software specialists and testers, 21 CFR Part 11,
data acquisition and control, process control.
US Data
Management
US Data Management serves the medical research and manufacturing
industries by providing skilled resources for rapid progress in
computerized system quality related efforts including strategic
consulting, system testing and documentation, software system and vendor
audits, and software development and modification.
Vanguard Integrity
Professionals
Vanguard offers an integrated suite of security software products and
expert consulting designed to exceed today's exacting standards and
unprecedented security challenges. Vanguard products bring together
formerly separate functions of security administration, access,
authentication, reporting and analysis, and policy compliance. Each
product can be used independently or together as an integrated solution.
Veridyn
Veridyn Inc. is a top-tier provider of comprehensive network security
solutions. We offer independent security consulting to meet a wide array of
business security needs. Veridyn services include the assessment and
development of complete security programs for the private and public sector.
Our engineers are well versed in the latest technology, trends, and
regulations that impact your business needs.
VisionShare
VisionShare provides affordable, secure communication solutions that are
compliant with 21 CFR Part 11 and the Health Insurance Portability and
Accountability Act (HIPAA). VisionShare products include easy-to-use file
transfer and e-mail and solutions that ensure secure communication with
trading partners over the Internet. VisionShare staff have drawn upon years
of experience in health care and government to deliver products, services
and training that allow companies to leverage the efficiencies of the
Internet while ensuring compliance with federal regulations.
Xcert
Xcert is an innovator in developing software for conducting secure
e-commerce and Internet transactions. Xcert's Public Key Infrastructure (PKI)
digital certificates let pharmaceutical companies easily control their
online information security, including privacy, authentication, and access
control. Xcert's scalable software suite helps pharmaceutical companies
adhere to 21 CFR Part 11 concerning data security and digital signatures.
Download our free FDA white paper.
XML4Pharma
XML4Pharma provides expert knowledge of pharmaceutical XML based data
standards. XML4Pharma delivers archiving solutions in XML format, the only
really 21-CFR-Part11 compliant archival format (guaranteed to be readable
in 20 years from now). Archiving your data in XML means that your data
remain readable, even if your computer system is not supported anymore.
XML4Pharma further delivers services in the area of vendor neutral
e-signatures (XML-Signature) & encryption technologies (XML-Security).
ZignX
The ZignX Medical is a hardware based add-on solution securing existing
laboratory and production equipment according to FDA requirements for 21
CFR Part 11. ZignX Medical works 100% independently and provides systems
Access Control, User Rights, Log-Off function, Recording of Log Events,
Raw Data from instruments, Audit Trail, secure handling of data, etc.
ZignX can be added to both new and old systems providing a sophisticated,
flexible and easy-to-use front-end solution.
