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Tescom US

Tescom US | Conformation | Scoop.it

We’re a software testing firm and we’ve been in Atlanta since 1999.

We’re unique because software testing and quality assurance is all we do, and it’s all we’ve ever done.

Testing is not about making the best software product possible. Testing is about making the most profitable software possible.

Some executives place testing in the same line item as coffee as though no one in their right mind would cut either out of a technology budget.

We know no one wants to pay for testing but everyone wants it to work the first time, and every time, and correctly.

Thomas Poirier's insight:

Excellente approche éditoriale. Voir aussi les valeurs.

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Sunrise Regulatory Agency Approvals | Product Development Compliance

Sunrise Regulatory Agency Approvals | Product Development Compliance | Conformation | Scoop.it
Regulatory Agency Approvals - Sunrise Labs is a product development company specializing in embedded systems design, medical products, electronics, and consumer product design.
Thomas Poirier's insight:

Bons communicants

It’s a regulated world and we are experts at winning agency approvals in several areas. Our experience allows us to design compliance in from the start rather than cross our fingers, iterate the design, and test and re-test when a product is suppose to be shipping.

We also follow our ISO 9001 and ISO 13485 certified design control processes to ensure the proper steps are taken to win FDA or other regulatory approval to market your device.

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Home | Regulatory System Compliance Partners

Home | Regulatory System Compliance Partners | Conformation | Scoop.it
GxP Compliance Services and Solutions tailored to your Needs
Thomas Poirier's insight:

Très bons. Même charte que Pharmasys.

The pharmaceutical market is changing at a rapid pace due to different business models and various mergers and acquisitions. The regulations and business requirements are increasing and in the organizational complexity they become more demanding to meet. For instance pharmaceutical companies face the challenge of diversification in the sense that topics like IT Compliance and validation are addressed on various sites on an operational level. Rescop can help create transparency in these areas and support in achieving efficiency benefits through harmonization and optimization. Rescop offers pharmaceutical industry software, including a Product Suite to support the relevant processes and provides consultancy services to advice on various levels and in different areas.

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Quality & Compliance Solutions | RTP, NC & Nationwide | Sequence, Inc.

Quality & Compliance Solutions | RTP, NC & Nationwide | Sequence, Inc. | Conformation | Scoop.it
Sequence, Inc. is an industry leader in quality & compliance for regulated manufacturers. We offer validation consulting & more nationwide & internationally.
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Regulatory Compliance Software Solutions | Compliance Associates

Regulatory Compliance Software Solutions | Compliance Associates | Conformation | Scoop.it
At Compliance Associates we offer software and consultant services to provide quality solutions and optimize regulatory compliance and validation processes.
Thomas Poirier's insight:

Compliance Associates delivers solutions that are anchored in industry expertise, experience and best practices so that your internal resources can focus on the core business. Our approach gives clients the freedom to choose only the services needed with the potential to custom-build an integrated suite of services that best fits your company requirements...

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Veracord

Veracord | Conformation | Scoop.it

We deliver solid, creative, tailored solutions for regulated industries. Ourproven experts support the Life Science Industry, assist with needs for meet your clients’ clinical, medical, compliance, and regulatory needs. Everything we do is backed by an uncommon commitment to our clients, from handshake to project completion.

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Valicom: Validation and Compliance Services for the Regulated Medical Industries

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Verdandi AG, Zürich, Switzerland

Verdandi AG, Zürich, Switzerland | Conformation | Scoop.it

Independent Quality and Process Management Consultancy focused on :

Regulatory Compliance
Quality Management and Quality Assurance
Process Analyses and Design
Business Risk Assessment

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Quintiles - CRO, Clinical Trial Services, Pharmaceutical Consulting

Quintiles - CRO, Clinical Trial Services, Pharmaceutical Consulting | Conformation | Scoop.it
Quintiles helps pharmaceutical and healthcare companies navigate the complex, heavily regulated process of bringing a drug or medical device to market.
Thomas Poirier's insight:

Great corporate assesments

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PENSA Technology Solutions Inc., About Us

PENSA Technology Solutions Inc., About Us | Conformation | Scoop.it
Thomas Poirier's insight:

PENSA uses Quality Engineering methods
PENSA Technology Solutions Inc. will deliver innovative Information Technology solutions that meet or exceed worldwide regulatory and quality standards.

PENSA specializes in computer system validation projects
Specializing in computer system validation projects for pharmaceutical, medical device and biotechnology manufacturers, PENSA can guide your Life Sciences company toward meeting worldwide regulatory compliance. PENSA's validation products and services include 21 CFR Part 11 assessments, quality audits, creating/managing compliance documentation and validation training which follow cGMPs as put forth by the FDA.

PENSA's extensive in-house experience makes the difference
PENSA is knowledgeable in compliance projects for ERP, LIMs, CMS, DMS, MES and any process or lab equipment.

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Validation, Bioinformatics, ETL, Technical Writer, HR Abap Jobs

Validation, Bioinformatics, ETL, Technical Writer, HR Abap Jobs | Conformation | Scoop.it
Check our new job openings for validation, bioinformatics, etl, technical writer, sms, documentum and sas jobs at IT staffing agency NewAge Sys
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Integrity Solutions

Integrity Solutions is a leading supplier of business management solutions, project management solutions and quality management solutions. Integrity Solutions specialise in Business management, Process Control solutions and IT System solutions. Visit Integrity Solutions for business advice today.
Thomas Poirier's insight:

Integrity Solutions are leading providers of quality and compliance solutions. Our extensive experience includes pharmaceuticals, medical device, biotechnology and cosmetics.

Integrity Solutions’ experience extends across the complete lifecycle of product research, development, manufacturing, distribution and pharmacovigilance.

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Home

Home | Conformation | Scoop.it
Thomas Poirier's insight:

Brock Solutions is an engineering solutions and professional services company specializing in the design, build and implementation of real-time solutions for broad based industrial/manufacturing and transportation/logistics organizations globally. 

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Accueil

Accueil | Conformation | Scoop.it

Fondée en 1993, ADN s'est consacrée exclusivement aux conseils en systèmes informatisés et réglementaires pour l'industrie pharmaceutique et les dispositifs médicaux.

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Valimation. Bridging technology to compliance

Valimation. Bridging technology to compliance | Conformation | Scoop.it

ValiMation provides technology, compliance and validation solutions for GMP, GCP and GLP applications used in pharmaceutical / biotechnology / medical device industries. We specialize in 21 CFR Part 11 solutions that span process automation, lab automation and IT.

Our collective expertise in technology, processes and compliance helps us provide high quality, cost effective and pragmatic solutions to our clientele.

Thomas Poirier's insight:

ValiMation is a great choice for computer system validation. They are knowledgeable, responsive and provide value to our compliance program. Jim McElroy, Manager, Compliance Engineering Novartis

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USDM - Life Sciences

USDM - Life Sciences | Conformation | Scoop.it

USDM is a leading global professional services firm focused exclusively on providing business process, technology and compliance solutions for the regulated life science industry.  USDM's professionals are recognized thought leaders in emerging life science computer system topics. They are experts in improving business value through the implementation and adoption of new technologies that run regulated business processes.

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Software Quality Associates

Software Quality Associates | Conformation | Scoop.it
Software Quality Associates believes that quality assurance and software qa testing is about always striving for improvement and reducing ineffeciencies.
Thomas Poirier's insight:

Software quality. Done right. Bonne visualisation du process.

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Quality By Design and Process Validation

The FDA has made significant progress in implementing the concepts of “Quality by Design” (QbD) into pre-market processes.
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Xybion Corporation

Xybion Corporation | Conformation | Scoop.it
The #1 Integrated Compliance, Quality, Risk & Laboratory solution for life sciences & highly regulated industries


Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Our unique solutions focus on regulatory compliance, GRC, quality management, GLP, integrated preclinical lab management, early-stage drug discovery, content migration and systems validation. Xybion specializes in helping companies improve their overall compliance processes and provides a complete view into organizational risk across global organizational models.
Xybion's combination of software, business process management, services, validation and staffing enables us to cover a broad spectrum of critical business needs for companies and we deliver our solutions on global scale. Since it's founding in 1977, Xybion Corporation has supported, through software, services and consulting, 100% of the top 20 global life sciences companies. Our leadership in this dynamic and ever-changing industry has been a cornerstone of our high-value reputation.
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THINQ Compliance Manager Software

THINQ Compliance Manager Software | Conformation | Scoop.it

Moving Compliance from "Burdensome Cost" to "Competitive Advantage"

 

Automating Validation Programs to Achieve the Highest ROI

 

Providing One System of Record for Real Time Data to Shorten FDA audits

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SoftwareCPR

SoftwareCPR | Conformation | Scoop.it

We provide full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software - and technical files, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.

Thomas Poirier's insight:

Super statutaire

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QS Labs - Quality Systems Laboratories

QS Labs - Quality Systems Laboratories | Conformation | Scoop.it
Thomas Poirier's insight:

Quality Systems Laboratories (QS Labs) is a global compliance management and solutions provider for the life sciences and healthcare industries. Our mission is to integrate people, process, and performance through our intelligent compliance solutions for companies that are required to meet regulatory and quality standards.


QS Labs offers regulatory compliance and risk management solutions by decreasing uncertainty and reducing variability.

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Welcome to META Solutions!

Thomas Poirier's insight:

META Solutions, Inc. was founded in 1987 to provide quality software development and information technology-related consulting services for the pharmaceutical and related health care industries. Initial projects were based on the founders' areas of expertise, which included the definition and analysis of functional requirements for computerized document and information management systems, custom software development, and consultation regarding regulatory compliance and validation of clients' computer systems.

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LIMS Home page

LIMS Home page | Conformation | Scoop.it
Thomas Poirier's insight:

Laboratory Systems Consulting (LSC) is a Professional Servicesorganisation whose knowledgeable and experienced team help you define, select, implement and support Information Management Systems in theQuality and Compliance functions. Achieving and maintaining compliance with FDA 21 CFR Part 11 and European Regulations is a fundamental consideration.


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IBM - Security Compliance

Thomas Poirier's insight:
Increasing time and cost of addressing regulatory and industry requirements - existing and new, disconnected regulations and industry mandates demand more and more resources to meet compliance standardsDifficulty understanding and managing IT security risks - you need to prevent data breaches and inappropriate data disclosure, while ensuring there is no impact on business and productivityIncreased time and effort required to maintain proper levels of compliance and internal control - When a breach does occur, every second counts to minimize exposure to company's business operations, image or financial position
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