Solution Providers
Hardware and Manufacturing Execution Systems
To add a solution provider, go to our Submission Page
American MSI
Celltrack PRO™ is an enterprise solution for manufacturers of medical
devices that need to record, maintain, archive, retrieve, and transmit
relevant manufacturing data, in compliance with the FDA's 21 CFR Part 11
regulation. With Celltrack PRO™ you can record, maintain, archive,
retrieve, and transmit relevant manufacturing data, including batch detail
and downstream processing, equipment settings and measurements, as well as
who changed what, when, where and even why.
Andover Controls
Andover Controls is a leading supplier of facility automation systems for
the Biotech, Medical Devices and Pharmaceutical markets. Our flagship
product, the Continuum Facility Management System, provides environmental
control and security management for FDA regulated facilities worldwide.
Continuum's CFR Compliance Pack facilitates compliance with 21 CFR Part 11
through the use of detailed audit trails and electronic record and
signature management capabilities.
Apriso
APRISO bridges the gap between the traditional paper environment and
electronic information environment by delivering dynamic, collaborative
manufacturing and supply chain execution systems that meet 21 CFR part 11
regulations. Apriso solutions provide real time collaborative
manufacturing initiatives including: workflow design management,
electronic signatures, electronic batch record management, recipe
management, process standardization, digitization, and detailed audit
visibility.
Aspen
Technology
Aspen Technology, Inc. is the leading supplier of integrated software and
solutions that enable pharmaceutical and CPG manufacturers to automate and
optimize their plants and extended supply chains, while enabling
e-business. With deep process knowledge, best-in-class technology, and
strategic alliances with leading business and technology partners,
AspenTech offers the industry's broadest family of scaleable solutions,
including Manufacturing Execution Systems (MES), process modeling tools,
and real time information solutions.
Camstar
Manufacturing medical devices demands great attention to both process
detail and product tracking. With Camstar's Virtual Factory, manufacturers
can integrate live manufacturing information with multiple business
systems already in place for - Meeting FDA regulatory requirements
(21CFRpart11), Speeding time-to-market, and reducing liability.
Capstone Technology Corporation
Capstone’s DataPARC Suite is a real-time analysis system enabling plants
to reduce variability, improve efficiency and quality. Its reliable
acquisition, collection and storage solution enables 0% data loss. It’s
audit trailing enable manufacturers to achieve 21CFR Part 11 compliance.
The intuitive, feature rich analytical tools enable users throughout the
enterprise to convert data into useful information, make timely decisions
and recognize relationships in data located in separate systems.
CIMNET
Factelligence is a modular, web-based MES that can manage, track, and
optimize your pharmaceutical factory from detailed product definition,
through processing and on to packaging line management. At each operation
it provides detailed formulations and procedures to plant personnel as
well as collecting quality data from plant control systems and operators.
Factelligence provides your ERP and LIMS with dynamic and accurate facts
on products, quality, plant availability and production capacity.
Core Technologies (India)
We manufacture Low cost dedicated configuration Data Loggers tailored
for DHS, Auto Clave and Tunnel Validation, Pharma-LOG 1.0 as a Hybrid
System assuring maximum security of data and reports, Audit trails,
traceability to national standards. We also provide validation service.
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.
Decision
Management International
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.
Ellab
Thermal validation solutions from Ellab have been developed according to
GAMP standards and the performance has been carefully documented. FDA
accepts validation data from Ellab solutions. And of course our software
is 21 CFR, part 11 compliant. Ellab supplies both cable based systems (E-ValTM)
and wireless systems (TrackSense®) for validation and monitoring thermal
processes in the pharmaceutical, medical devices and food industries.
Emerson
Process Management
Emerson Process Management, formerly Fisher-Rosemount is a global supplier of process management products and
solutions, including control valves, regulators, transmitters, analyzers,
process automation systems, software, and services. The DeltaV digital
automation system is built for process manufacturers in the FDA regulated
industries like pharmaceutical and biotech manufacturers.
Forte Industries
Forte Industries provides world-class supply chain consulting engineering,
design/build, and continuous process improvement services under a true
single-source umbrella. We have worked with several medical suppliers to
automate their distribution centers and design / implement new ones - all
in compliance with gov't and medical regulations. Our expert staff of
Supply Chain Solutionists™ can analyze, design and integrate solutions
that work - and with true single-source responsibility.
Global Vision
Global Vision is a world leader in the design, manufacture and delivery of
automated Quality Control Inspection Systems which integrate applications
that comply with 21 CFR Part 11 technical requirements. It offers a
complete portfolio of leading-edge solutions for any offline, quality
control/inspection or proofreading application, including file-to-file,
intelligent OCR, artwork inspection, non-contact counting and
high-security character inspection systems.
GTI
Gesellschaft fur technische Informatik mbH.de
Scarabaeus+ is a GMP/FDA compliant software solution that covers all
aspects of pharmaceutical production, QC, purchase, sales and shipment. It
manages computer based recipes, production instructions, analysis plans,
weighing operations as well as complete material flow with batch tracking.
Scarabaeus+ comprises a full audit trail facility as required by 21CFR
Part 11 and a compliant user identification and authorization shell. The
development cycle is documented following the latest guidelines.
Intellution
Intellution, Inc., is a leading supplier of eManufacturing solutions for
industrial automation, develops software solutions to help businesses from
across the FDA-regulated spectrum move toward 21 CFR Part 11 compliance.
Intellution draws upon a twenty-plus-year history of providing
award-winning software solutions that collect, control and manage
information from the plant floor for distribution throughout the
enterprise.
Invensys
Pharmaceutical Solutions
Invensys Pharmaceutical Solutions is a leading supplier of manufacturing
control (I/A Series System, Wonderware), manufacturing execution (Avantis)
and environmental systems that meet and exceed the guidelines of 21 CFR
part 11. Invensys Pharmaceutical Solutions has a dedicated group of
pharmaceutical engineers and specialists focused on this industry. We
offer a full range of validation services (VTI), automated tools and
procedures to help enable compliance to 21 CFR part 11. We leverage our
expertise to provide systems, tools, policies and procedures for
compliance.
iTAC
Software
iTAC Software provides Collaborative Production Management solutions to
help medical device manufacturers comply with GMP requirements. Our
web-centric solution provides a documentation trail of all as-built
manufacturing data by serial number such as bill of materials, process
parameters, test results, repair and rework, and as-built notes. With easy
works, anyone with a web browser and user access rights can monitor and
interact with production from anywhere in the world. Customers can be
provided with visibility into the status of their orders. Suppliers can
view the inventory and quality performance of their products as well.
JAG
JAG Jakob Prozesstechnik AG specializes in process technology and
automation for pharma and food. JAG is a solution provider and is
experienced in handling projects from basic design to fully functional
plants. GMP-conforming documentation is considered a very high priority
and is organized as an ongoing task, such that qualification and its
relative documentation is finished at the same time as the project is
completed. Together with its proprietary automation system, JAG is in a
position to deliver completely automated, paperless pharmaceutical plant
installations, fully compliant to 21 CFR part 11.
Johnson Controls Inc.
Johnson Controls offers compete, validated building environmental
solutions for facilities in a variety of industries, including Life
Sciences, Healthcare, and Food & Beverage. Our cost-effective, time-proven
products and processes will help you achieve Part 11 compliance quickly
and efficiently. From a technology standpoint, Johnson Controls has
developed a solution focused directly on the needs of critical
environments-Metasys for Validated Environments
Kaye
Kaye is a leading supplier of systems for
quality assurance in thermal validation, stability and facility
monitoring, and engine test cell applications. These solutions serve the
pharmaceutical, biotechnology, medical device, and aerospace industries.
The Validator 2000® is a standalone thermal validation solution designed
to meet new guidelines and industry demands. It is specifically designed
to conform with new FDA data protection guidelines (21 CFR Part 11) and
agreements that meet international and European norms (ISO 10012) for
inspection of pharmaceutical, biotechnology and medical device (EN285,
EN554) manufacturing plants.
Lecan
Group
Lecan offer a 21CFR11 Technological Compliant software suite designed for
Medicare & Pharmaceutical Manufacturers. It leverages existing
infrastructure and makes applications available securely throughout the
organization. It consolidates and integrates applications to allow “one
view” of previously disparate systems. Key elements include:
Consolidated Passwords, Security infrastructure, Time & Date Stamping,
Audit Trails, Enterprise User Registry.
Netindia
Private Limited
Netindia is an Embedded Networking Technology Based Organization. Netindia
focused its development into the arena of Industrial Automation & Remote
Monitoring Solutions. Key areas of concentration in the Industrial
Automation were the Field Bus, PROFIBUS, MODBUS, DEVICENET, CAN and other
Industrial Communication Standard Protocols Etc. The company is
focusing on the overseas markets to take up embedded technologies projects
in the communication, remote monitoring and networking sectors and plans
to tap the Overseas market to market its products and service based
models.
Panorama
Because of the requirements needed in the pharmaceutical industries,
PANORAMA enables each industry's regulatory requirements that governs
the manufacturing quality to be met. In particular in meeting the FDA
requirements CFR21part11. Within PANORAMA, there are the necessary
functions which allow the client to obtain the necessary industrial
certification for the installation. PANORAMA version 8 now integrates
the use of biometric technologies.
PcVue Industrial Office
ARC Informatique is one of the foremost European companies in publishing
software for industrial automation. For 20 years, ARC Informatique has
kept pace with companies in the pharmaceutical, chemical and cosmetic
fields, and directed its developments to afford a suitable solution for
traceability of information. The PcVue supervisory software package,
published by ARC Informatique, integrates the functions resulting from 21
CFR Part11 Controls, including electronic signatures, audit trail, …
POMS
POMS Corporation is the
global leader in providing Manufacturing Execution Systems (MES) for the
healthcare products and consumer packaged goods industries. The company's
solutions are an essential component to successful E-Business supply
chains, providing manufacturers with agility in their product development
and manufacturing operations.
Propack
Data
Propack Data was first established as a company in 1984. As a pioneer and
visionary in the Manufacturing Execution System (MES) sector, Propack Data
has risen to become the leading supplier for the pharmaceuticals industry.
Focusing on FDA/GxP-regulated industries such as pharmaceuticals,
food-stuffs and cosmetics, Propack Data delivers validatable standard
software for complete product execution in all areas of supply chain
execution under ERP.
Real
Vision
RealVision, Inc. has been providing a single source solution for the
manufacturing environment, we started in 1982 developing a
"Manufacturing Execution System" for our own brake mfg. company.
First public release to the open market was in 1986. Today our
ProDocTivity™ suite is designed to improve productivity,
enhance efficiency, reduce scrap, and seamlessly merge all manufacturing
tasks with control. The system is easily adaptable in all manufacturing
environments and we provide many flexible options so your company can
operate the way that best suit your needs
Siemens
SIMATIC IT offers a “component-based” approach, in which all the functions
required by the production system are provided by independent Components.
Product Tracking, Quality Management, Batch Execution, Material
Management, Detailed Scheduling, and many other components. But connecting
the components is not enough. In an efficient MES system the basic
components must be coordinated and synchronized to the production strategy
of the plant. This is the second function of SIMATIC IT.
Validation Specialists
Inc.
Validation Specialists insures their clients equipment, software, and
process validations comply with National and International Validation
Standards
Werum
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.
Xyntek
Xyntek’s Manufacturing Execution System (ITX-MES) fills the gap between
high-level business management tools and real-time automation and
manufacturing systems by providing inventory management, material quality
control, EBR(electronic batch records), manufacturing and packaging
capabilities, and full material genealogy for GxP environments. Xyntek’s
ITX-MES provides and maintains information that meets Food and Drug
Administration audit requirements.
