Software Medical Device Manufacturing Company Launches New Quality Management System in Record Time
Case Study | Jul 16, 2020
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Specialty Technical Publishers (STP) is one of North America’s premier publishers of comprehensive technical online resource guides in the areas of environmental, health and safety, transportation, business practices, standards and laws.
Enhesa helps global multinational companies be compliant with, and stay on top of, Environmental, Health & Safety (EHS) regulations wherever they operate. Enhesa’s in-house team of multilingual regulatory analysts provide clear, concise and standardized content and insight on current and future EHS regulatory obligations worldwide. Enhesa’s Compliance Intelligence and Regulatory Forecaster services can be provided as an automated datafeed – integrated with the world’s leading EHS software platforms. Enhesa has offices in Brussels, Washington D.C., Toronto, Shanghai and Tokyo.
Box (NYSE:BOX) is a leading cloud content management platform that enables organizations to accelerate business processes, power workplace collaboration, and protect their most valuable information, all while working with a best-of-breed enterprise IT stack. Founded in 2005, Box simplifies work for leading organizations globally, including AstraZeneca, General Electric, JLL, and Morgan Stanley. Box is headquartered in Redwood City, CA, with offices in the United States, Europe, and Asia.
Rootstock Software® is a worldwide provider of cloud ERP on the Salesforce Cloud Platform. When combined with Salesforce CRM, Rootstock Cloud ERP offers manufacturing, distribution, and supply chain organizations a single platform to grow and manage their businesses. Rootstock Cloud ERP is a flexible, modern, and digitally-connected system that transforms companies to deliver a more personalized customer experience, efficiently scale operations, and out-service the competition.
Big Bang is a consulting firm that helps organizations optimize and streamline processes through planning digital strategy, deploying business solutions, and creating organizational alignment. Our purpose is to create tangible value for our customers by helping them to streamline business systems including, connecting information between systems, aligning strategy with technology, and providing support to develop organizational expertise. Our vision is for all people, in every organization, to have direct access to the information that enables them to do their best work anywhere and every day. With headquarters in Montreal, Canada, and offices in France, Mauritius, and the United States, we aim to serve enterprises of all sizes and industries worldwide.
3T Innovations maintains long standing business partnerships and direct relationships with government agencies. As an experienced and sophisticated organization that recognizes the cost and time associated with the process of procurement they continually look for ways to ease the administrative burden associated with meeting the needs of customers through establishing contract vehicles that enable a simplified path to procurement.
DigiPartnerIT Oy is a consulting company specialized in IT digitalization for small and medium-sized businesses. They have expertise in both IT and business, giving them a unique experience and ability to operate in a business – IT environment. Their uncompromising attitude towards quality of work ensures customer satisfaction!
iEnterprise Online Sdn Bhd is a subsidiary of Bursa-listed Ancom Berhad. Specializing in Oracle and Java technologies, they offer ERP software and other industry-specific solutions, and Analytics & Big Data solutions for the Financial services, Manufacturing, Logistics, Government and Services sectors.
Cloudloop, is a North American based Salesforce.com Systems Integrator (SI) committed to delivering unprecedented efficiency and ROI through the Platform. We have successfully onboarded Medical Device Companies, pre-commercialization and pos-commercialization, across a broad range of applications to a deliver deeper, more integrated and automated physician and patient journeys without forgoing the personalized human touch.
Pharmaceutical Compliance Partners, LLC is a network of experienced consultants who focus on helping start-up, small and mid-sized companies fill talent gaps in their Regulatory, Quality and Compliance teams. Our team members are available for interim leadership positions, full and part time staff augmentation, project leadership and support, virtual engagements, part-time on-site support and short-term, national and global travel assignments.
Salesforce has held the TüV Rheinland CCS certification for the past four years now. The TüV Rheinland CCS certification currently does not apply to the following Salesforce Services: Site.com, Database.com and Communities.
Salesforce is a founding member and has been certified since 2008. The ASP/SaaS certification currently does not apply to the following Salesforce Services: Force.com, Site.com, Database.com, and Chatter.
PrivacyMark is considered a Japan equivalent of ISO 27001, and Salesforce has been certified since 2008. PrivacyMark is a legal entity-based program and it applies to salesforce.com Co., Ltd.
The EU-U.S. Privacy Shield Framework was designed by the U.S. Department of Commerce and European Commission to provide companies on both sides of the Atlantic with a mechanism to comply with EU data protection requirements when transferring personal data from the European Union to the United States in support of transatlantic commerce.
"Binding Corporate Rules" (or "BCRs") are company specific, group-wide data protection policies approved by European data protection authorities to facilitate transfers of personal data from the European Economic Area to other countries. BCRs are based on strict privacy principles established by European Union data protection authorities and require intensive consultation with European data protection authorities.
Salesforce Services Systems that are HITRUST CSF Certified: Force.com (Platform Services), Site.com, Database.com, Sales Cloud, Service Cloud, Community Cloud, Chatter, Einstein Analytics, Work.com, and Industries Applications (Financial Services Cloud, Health Cloud) at the following production data centers - WAS, CHI, CHX, WAX, LON, WAC, FRF, PHX, DFW, TYO, PAR and UKB.
Salesforce.com Exact Target products are HITRUST CSF Certified at the Atlanta, Las Vegas and Indianapolis data centers.
In October 2016, the U.S. Department of Defense (DoD) updated acquisition requirements for government contractors to provide more specific guidance in light of their continued use of cloud computing services as it relates to the transmission, storage, and processing of controlled defense information. When cloud services are used by a contractor as part of a system operated on behalf of the U.S. government, those cloud services are expected to comply with the requirements defined in the DoD Cloud Computing Security Requirements Guide (SRG). When cloud services are used by a contractor as part of a system not operated on behalf of the U.S. government, those cloud services are expected to comply with the Moderate Impact requirements defined by the Federal Risk and Authorization Management Program (FedRAMP).
Since May 2014, Salesforce has maintained a FedRAMP Authority to Operate (ATO) at the Moderate Impact level for the Salesforce Government Cloud. Further, as of January 2017, Salesforce was granted a Provisional Authorization for the Salesforce Government Cloud at Information Impact Level 4 (IL4) by the Defense Information Systems Agency (DISA). These authorizations may assist DoD mission owners and authorized contractors in their management of Controlled Unclassified Information (CUI), including Personal Identifiable Information (PII), Protected Health Information (PHI), and other mission-critical data requiring protection from unauthorized disclosure.
Additional information can be found at https://www.salesforce.com/solutions/industries/government/overview/.
The U.S. Department of Defense (DoD) has unique information protection requirements that extend beyond the common set of requirements established by the Federal Risk and Authorization Management Program (FedRAMP) program. Using FedRAMP requirements as a foundation, the U.S. DoD specifically has defined additional cloud computing security and compliance requirements in their DoD Cloud Computing Security Requirements Guide (SRG). Cloud Service Providers (CSPs) supporting U.S. DoD customers are required to comply with these requirements.
The Salesforce Government Cloud has been granted Provisional Authorization (PA) for Impact Level 4 (IL4) from Defense Information Systems Agency (DISA) leveraging Salesforce’s FedRAMP Moderate ATO and undergoing additional assessments by independent organizations. This provides DoD mission owners and authorized contractors the ability to utilize the Salesforce Government Cloud to manage Controlled Unclassified Information (CUI), including Personal Identifiable Information (PII) and Protected Health Information (PHI). This also includes data requiring protection from unauthorized disclosure and other mission-critical data.
Additional information can be found at https://www.salesforce.com/solutions/industries/government/overview/.
The Salesforce Government Cloud has been granted a Provisional Authorization (PA) for Impact Level 2 (IL2) from Defense Information Systems Agency (DISA) leveraging Salesforce’s FedRAMP Moderate ATO. IL2 is for non-Controlled Unclassified Information (non-CUI), which includes all data cleared for public release, as well as some DoD private unclassified information not designated as CUI or critical mission data that requires some minimal level of access control.
Additional information can be found at https://www.salesforce.com/solutions/industries/government/overview/.
In May 2014, Salesforce achieved and has since maintained a FedRAMP Agency Authority to Operate (ATO) at the moderate impact level issued by U.S. Department of Health and Human Services (HHS) for the Salesforce Government Cloud.
The SOC 3 report covers the Security, Availability, and Confidentiality Trust Services Principles.
The SOC 2 reports cover controls around security, availability, and confidentiality of customer data.
The SOC 1 reports are primarily concerned with examining controls that are relevant for the financial reporting of customers.
ISO 27017 provides guidance on the information security aspects of cloud computing, recommending the implementation of cloud-specific information security controls that supplement the guidance of the ISO 27002 and ISO 27001 standards. This code of practice provides additional information security controls implementation guidance specific to cloud service providers. The standard advises both cloud service customers and cloud service providers, with the primary guidance laid out side-by-side in each section.
The International Organization for Standardization 27001 Standard (ISO 27001) is an information security standard that ensures office sites, development centers, support centers and data centers are securely managed. These certifications run for 3 years (renewal audits) and have annual touch point audits (surveillance audits).
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Insight Success identifies ComplianceQuest as one of the 10 Most Innovative Companies in 2019 for building NextGen Quality and Compliance solutions for progressive customers. This award is given to ComplianceQuest for deploying emerging technologies to empower businesses with its EQMS Solutions.
Fastest Growing Native Salesforce Based EQMS Solution – Flexible, Scalable, Versatile and most importantly Reliable
We are delighted to announce that you are a recipient within Acquisition INTL magazine’s upcoming 2019 CEO of the Year Awards. I can confirm that you have been awarded the title of EQMS CEO of the Year 2019 – Southeast USA
For decades, the manufacturing industry has suffered from the lack of visibility in core areas such as supply chain, quality, and compliance. ComplianceQuest is addressing these issues with a modern cloud approach to Enterprise Quality Management Systems (EQMS) that leverages the technologies of industry 4.0 including Cloud, AI, Machine Learning, Big Data, Data Analytics, and Smart Connectivity.
"ComplianceQuest provides comprehensive capabilities in quality, safety and compliance business solutions to meet global regulatory changes and uncertainty."
ComplianceQuest is a 100% cloud-based Enterprise Quality Management Software (EQMS). Built using Salesforce.com, it is a tool for accelerating your organization’s growth from anywhere, anytime and through any device. It empowers enterprises to manage quality by collaborating with their supply chains – whether global or local – and even several layers deep, to stay compliant with industry, country, and customer specific regulations. While the company provides support across industries, it specializes in Consumer Packaged Goods, General Manufacturing, Life Sciences, and Oil & Gas.
"ComplianceQuest fast-tracks an organization’s efficiency, safety, and overall performance by combining modern cloud EQMS with the latest technology in collaboration, communication, and social media across the product value chain."
CIO Applications picks ComplianceQuest as a top 25 Life Sciences Technology Vendor for 2018.
In order to help companies seeking competent solutions in the Life Sciences domain, a distinguished panel has reviewed numerous Life Sciences Technology vendors and selected the top 25 vendors in 2018. Companies have been identified based on the quality of their solutions and services as well as customer satisfaction record.
"Our EQMS is a flexible cloud-based system built on Salesforce that is easy to use, implement, validate and be accessible on any device, anywhere, anytime."
The Fast 56 identifies, recognizes and celebrates the world’s fastest growing USF Bull-owned or Bull-led businesses. The 56 outstanding recipients of this award are picked from hundreds of applicants.
"ComplianceQuest was thrilled to be identified as the #3 fastest growing company amongst these. It is a high honor for all of us at ComplianceQuest and a testament to the commitment to customer success by our CQ team members, our incredible partnership with Salesforce and an amazing product developed by the CQ Team."
ComplianceQuest wins the 10 Most Recommended Quality Management Solution Providers of 2018 award.
Insight Success identifies ComplianceQuest as one of the 10 Most Recommended Quality Management Solution Providers of 2018.
"ComplianceQuest combines unparalleled experience across multiple industries with comprehensive capabilities in quality, safety and compliance business functions."
"Using embedded Salesforce tools such as ‘Chatter’, ‘Social Like and Follow’ and community portals, ComplianceQuest’s EQMS improves supplier collaboration, and minimizes manual data and email exchange, to quickly resolve quality and safety issues."
Chief Strategy Officer at ComplianceQuest
Xplorex IT (www.xplorexit.com) – Enterprise Technology Magazine has chosen ComplianceQuest (compliancequest.com) for its 10 Best Manufacturing Solution Provider 2018. The positioning is based on evaluation of ComplianceQuest’s offerings for EQMS and other products and services.
The annual list of companies is selected by a panel of experts and members of Xplorex IT’s editorial board to recognize and to promote technology entrepreneurship.
"ComplianceQuest has been on our radar for some time now for stirring a revolution in Salesforce and Cloud products, services and technology space, and we are happy to showcase them this year due to their continuing excellence in delivering top-notch technology-driven solutions,” said Adam Goldstein, Managing Editor, Xplorex IT. “ComplianceQuest’s solutions continued to break new ground within the past year benefiting its customers around the globe, and we’re excited to have them featured on our top companies list."
ComplianceQuest’s Enterprise Quality Management Solution is Recognized with Frost & Sullivan’s Entrepreneurial Company of the Year Award
The ComplianceQuest solution is an innovative Enterprise Quality Management System built on the modern cloud architecture leveraging advanced technologies such as collaboration, mobility, artificial intelligence, and machine learning. ComplianceQuest’s decision to use the Salesforce cloud is an astute decision to focus and drive innovation into its solutions while leveraging everything the Salesforce business platform provides today and in the future. The breadth of this timely solution’s offering clearly demonstrates the company’s path-breaking ability to rapidly deliver differentiated value in the market.
"ComplianceQuest’s unified suite of applications outperforms the competition in covering quality, manufacturing, supplier management, customer/field service, health and safety that will drive excellent business value for the customer."
ComplianceQuest’s Enterprise Quality Management Solution is Recognized with Frost & Sullivan’s North America Customer Value Leadership Award 2019.
Legacy systems that once seemed ideal are facing obsolescence, as they cannot address the rising complexities of today’s markets. Natively built and run on the Salesforce Platform, ComplianceQuest invigorates the industry with a cloud-based approach to quality management. Maintaining a firm customer-first mentality, the company’s solution delivers significant value and ensures customer satisfaction throughout the entire sales and solution lifecycle. Moreover, ComplianceQuest’s consistent growth in revenues, customers, and partnerships is well poised to position the company as a formidable presence in the enterprise quality management systems market. Frost & Sullivan predicts that collective value brought by the company’s strategic partnerships will ignite more interest and prove strategic in years to come.
"For its innovative focus, proven solutions, and strong overall performance, ComplianceQuest earns Frost & Sullivan’s 2019 North America Customer Value Leadership Award."
We have been inducted into Inc. 5000’s list of “Greatest Entrepreneurs and Fastest- Growing Private Companies in America for 2019”
With an eye-popping growth rate of 2,356.8% over the last 3 years, ComplianceQuest ranks at a very high position at #163 and has further made it to the elite Inc. 500, a subset of Inc. 5000 inductees.
ComplianceQuest has achieved this incredible honor under the strict criteria for revenue growth put forth by Inc. 5000 with less than 4 years of active selling.
The publisher of Inc. 5000, Rich Russey says “Each year the Inc. team gathers data, crunches numbers and compiles the Inc. 5000. The Inc. 5000 is not a mere list of the fastest-growing private companies in America, it’s the backbone of the U.S. economy. These businesses generate hundreds of thousands of jobs, and billions of dollars in revenue, in their home-towns across the country.While the Inc. 5000 issue always focuses on the companies whose growth rates boggle the mind, it also shines a light on the smart marketers who work tirelessly to help these companies achieve and maintain that level of growth year after year. In doing so, these marketers walk side-by-side with the founders and share the innovation that drives their success.”
"Our sincere gratitude goes out to our incredible team, valuable partners, our customers and our competitors who push us to bring our “A” game to each interaction."
Inc. magazine revealed that ComplianceQuest is No. 446 on its annual Inc. 5000 list, the most prestigious ranking of the fastest-growing private companies in USA. The list represents a unique look at the most successful companies within the American economy’s most dynamic segment—its independent and fast-growing businesses.
The AppExchange Team at Salesforce selected ComplianceQuest EQMS solution for this incredible award out of 3400+ Apps from the AppExchange listings based on
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Linear Health Sciences is a medical device company creating products for various types of medical tubing based on its proprietary, breakaway safety-valve technology. This platform technology is designed to improve the healthcare experience for patients, caregivers, and healthcare facilities. Linear has made substantial progress toward global patent protections and FDA clearance for the Orchid Safety Release Valve.
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The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into eleven geographical divisions of both medical and lay volunteers operating in more than 900 offices throughout the United States.
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The All India Movement (AIM) for SEVA (Service) is not just a ‘schooling’ initiative. It is an integrated community development program, reaching out to rural and tribal children across 16 Indian states. AIM for Seva helps tackle the problems related to rural education through the unique concept of a Free Student Hostel (Home).
The Girls Rock Camp is a grassroots movement that uses music as a medium to promote self-confidence, creativity, and a sense of community amongst girls and young women ages 7-17. The camp is led by an all female-identifying staff who offer music lessons, self-defense classes, zine workshops, lyric and creative writing workshops, yoga and meditation exercises, and so much more.
200 underprivileged children are educated free of cost. They are provided with all the books, stationery, and periodic health check-ups as well. They have a fully equipped classroom and most of them enjoy being able to get respite from the scorching heat for the 2 hours that they are in school.
This organisation strives to eliminate classroom hunger by implementing the Mid-Day Meal Scheme in the government schools and government-aided schools in India. Alongside, Akshaya Patra also aims at countering malnutrition and supporting the right to education of socio-economically disadvantaged children.
Founded in 1968, Hope Children’s Home has rescued nearly 5,000 children between the ages of infant to 18 years of age. Most of these children have been discarded, abused, unwanted, or orphaned although some of the children have simply come out of a situation where a parent just needed help.
Carahsoft is The Trusted Government IT Solutions Provider®. As a top-performing GSA Schedule and SEWP contract holder, Carahsoft serves as the master government aggregator for many of its best-of-breed technology vendors, supporting an extensive ecosystem of manufacturers, value-added resellers, system integrators and consulting partners committed to supporting the public sector.
Dragonfly Consulting, LLC. was incorporated in August of 2010. The partners, Nanci Hayward and Cherie Grishin, have decades of experience in the biologics industry. Additionally, Ms. Hayward has a thorough knowledge of transfusion medicine, laboratory science, clinical trials, and central laboratories. Ms. Grishin specializes in operations, budgeting, process development / improvement and business strategy. Both partners routinely fill the role of Authorized Official and have opened multiple blood banks and plasma centers. Together they form a team able to assist the client in driving new business processes, improve the efficiency of current business processes and train / mentor staff towards the client’s vision.
Vanenburg Software is a personalized Enterprise (ERP) solutions provider which takes care of our cloud based infrastructure which helped us to design future proof IT environment in cloud enabling the ease of adoption into our client environment.
USDM is a leading risk management, technological innovation and business process optimization firm for the life sciences industry. Its a regulatory compliance provider that ensures all our products are in compliance with the regulations. This alliance helped us to design cost effective GXP-compliant solutions.
Quality Consulting Group is a Customer Support provider in Puerto Rico and Costa Rica. We are partnered with QCG to strengthen our market reach and the ability to provide world class, localized support to customers in Puerto Rico and Costa Rica. The local experience and competence that QCG brings to the table, coupled with the depth, versatility and efficiency of implementation that ComplianceQuest offers is unparalleled.
Gerent is a strategic advisory firm which helps manufacturers with implementation of Salesforce solutions. Gerent has been successfully implementing technology solutions for both discrete and process manufacturers for the past 11 years. Gerent’s comprehensive services enable businesses of all sizes and markets to achieve their customer success goals using Salesforce solutions.
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading global information technology, consulting and business process services company. We harness the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help our clients adapt to the digital world and make them successful. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 175,000 dedicated employees serving clients across six continents. Together, we discover ideas and connect the dots to build a better and a bold new future.
Co serve is an Application Support provider in the regions of Indian sub-continent, South-East Asia and the Middle East. Compliance and regulation policies are ever-evolving in these regions. The objective of our alliance is to bring a robust EQMS solution built by quality experts and implemented and supported by local experienced technology consultants.
Atos provides a comprehensive suite of cloud and Salesforce-based solutions. This includes test automation, continuous integration, and development (CI/CD), DevOps automation, and automated support and monitoring driven by SyntBots®. This alliance was made to drive success for our mutual customers via reliable, scalable and cloud-native EQMS solution.
The mission is to empower the local church and village community to meet the great need of the many orphans and widows through the development of an orphanage. This mission is located deep in the heart of the bush of Zambia, 2 hours away from the closest small town called Kalomo.
Culture Through Compassion. An NGO that works selflessly to build shelters for earthquake victims in Nepal. Yogdaan endeavors to get disaster relief to areas that need it the most and that have been hit the hardest.
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