OCTOBER 5 – 6, 2016: American Medical Device Summit 2016

The Generis American Medical Device Summit sets the standard on how the industry should connect and exchange ideas. Join the discussion with over 175 of your industry peers as we explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization. Hear first-hand case studies and walk away with strategic insights to streamline processes, reduce costs, and remain compliant in an ever evolving environment. This October we encourage you to join us for two days of thought provoking content and exceptional networking at the 2016 Generis American Medical Device Summit.

WEDNESDAY, SEPTEMBER 28, 2:00pm: Webinar – It’s all about the Data… Integrity that is!

Data integrity requires data to be Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). Being in a regulated industry, you know data integrity has always been important and you’ve undoubtedly been wrestling with the best way to ensure that integrity. How much and to what extent can data integrity be assured through laboratory software systems (i.e. LIMS and ELN)? What aspects need to be addressed through processes and procedures? How do you ensure that your laboratory systems and staff comply with the recent Data Integrity Regulatory Guidance from the FDA?

Benefits of a LIMS implementer’s firsthand laboratory knowledge

No LIMS, no matter how great it may be, is one hundred percent beneficial without proper implementation and training. Modern day LIMS are too complex with too many functions to truly just figure out on your own. However, many times, a LIMS implementation has failed simply because the implementer understood the computer system but fail to comprehend the laboratory itself or vice versa.

Benefits of a LIMS implementer’s firsthand laboratory knowledge

No LIMS, no matter how great it may be, is one hundred percent beneficial without proper implementation and training. Modern day LIMS are too complex with too many functions to truly just figure out on your own. However, many times, a LIMS implementation has failed simply because the implementer understood the computer system but fail to comprehend the laboratory itself or vice versa.

New Data Integrity Draft Guidance – Are You Ready?

With more and more companies in the pharmaceutical and life science industries moving to electronic data collection, analysis, storage, and reporting, the responsibility for knowing where your data are at all times and whether they are accurate and reliable is paramount for being compliant.

New Data Integrity Draft Guidance – Are You Ready?

With more and more companies in the pharmaceutical and life science industries moving to electronic data collection, analysis, storage, and reporting, the responsibility for knowing where your data are at all times and whether they are accurate and reliable is paramount for being compliant.

DUE: OCTOBER 14, 2016: Request for Proposal – Laboratory Information Management System (LIMS)

The Department of Administrative Services, Procurement Services, on behalf of the Oregon Department of Agriculture (ODA)issues this Request for Proposal for the acquisition and implementation of a laboratory information management system for the ODA laboratories in Portland and Salem Oregon.

Laboratory Informatics Weekly Update – Volume 14, Issue 37

September 21, 2016      Laboratory Informatics Weekly Update  Volume 14, Issue 37   In This Issue  Event Focus SEPTEMBER 26-30, 2016: 14th Cold Chain GDP & Temperature Management Logistics Global Forum The world’s largest event for temperature-controlled life science supply chains will return this year with extended topic focuses, session formats, speaking faculty and vendor options. Update and adapt your supply chain processes to tackle future challenges and ensure maximum compliance and quality at minimum cost. With constant evolving regulatory requirements across the globe, the 14th Cold Chain – GDP & Temperature Management Logistics Global Forum will help your company balance quality,…

Making the leap from research laboratory to clinic: Challenges and opportunities for next-generation sequencing in infectious disease diagnostics

In this late 2015 review and background article, Goldberg et al. provide the details of discussions held during meetings leading up to a February 2016 colloquium hosted by the American Academy of Microbiology on the Applications of Clinical Microbial Next-Generation Sequencing. The details of these meetings reveal the state of next-generation sequencing, its clinical applications, and the regulatory, financial, and research barriers that exist in NGS' further expansion in clinical settings. They conclude that "[t]he rapid evolution of NGS challenges both the regulatory framework and the development of laboratory standards and will require additional funding and incentives to drive tangible improvements and progress" to realize "the potential benefit that NGS has for patients and their families."

AACC Advocates Against Expanded FDA Oversight of Laboratory Developed Tests to Senate HELP Committee

Reforming CLIA Instead Will Protect Innovation and Patient Access to Essential Laboratory Developed Tests

Sanford Health Selects GenomeNext to Provide Enterprise Genomic Analysis Platform for Personalized Medicine Programs

GenomeNext, LLC, a leader in genomic data management and integrated analysis, announced today that Sanford Health, a Dakotas-based non-profit health system, and one of the largest integrated health systems in the nation, has selected GenomeNext’s Olympus Platform to deliver comprehensive genomic analysis and data management capabilities to expand its personalized medicine program across multiple U.S. regions.

Consultant LIMS

Consultant – Editeur de solutions logicielles de gestion de données de laboratoires – « LIMS / ELN »

Paris  + déplacements ponctuels

 

 

Société d’envergure mondiale, nous avons acquis au long de nos 20 ans d’existence une position de leader incontesté de solutions de gestion de données de laboratoires – R&D et Contrôle Qualité en production.…

Consultant LIMS

Consultant de Déploiement

Editeur de solutions logicielles de gestion de données de laboratoires – « LIMS / ELN »

Lyon  + déplacements ponctuels

Société d’envergure mondiale, nous avons acquis au long de nos 20 ans d’existence une position de leader incontesté de solutions de gestion de données de laboratoires – R&D et Contrôle Qualité en production.…

Deployment consultant LIMS

Consultant de Déploiement

Editeur de solutions logicielles de gestion de données de laboratoires – « LIMS / ELN »

Lyon  + déplacements ponctuels

 

 

Société d’envergure mondiale, nous avons acquis au long de nos 20 ans d’existence une position de leader incontesté de solutions de gestion de données de laboratoires – R&D et Contrôle Qualité en production.…

Deployment consultant LIMS

Consultant de Déploiement –  Editeur de solutions logicielles de gestion de données de laboratoires – « LIMS / ELN »

Paris  + déplacements ponctuels

Société d’envergure mondiale, nous avons acquis au long de nos 20 ans d’existence une position de leader incontesté de solutions de gestion de données de laboratoires – R&D et Contrôle Qualité en production.…

Service Delivery Manager LIMS

Société d’envergure mondiale, nous avons acquis au long de nos 28 ans d’existence une position de leader incontesté de solutions de gestion de données de laboratoires – R&D et Contrôle Qualité en production. Nous sommes présents dans des secteurs très divers : recherche clinique, laboratoires pharmaceutiques, industrie agro-alimentaire, pétrole, pétrochimie, luxe, environnement ….…

MathWorks Announces Release 2016b of the MATLAB and Simulink Product Families

)--MathWorks today introduced Release 2016b (R2016b) with new capabilities that simplify working with big data in MATLAB. Engineers and scientists can now more easily work with data too big to fit in memory. R2016b also includes additional features in Simulink; a new product, Risk Management Toolbox; and updates and bug fixes to 83 other products.

LabWare Developer

 

LabAnswer is the leading laboratory informatics consultancy in North America. We work with “best in breed” Laboratory Informatics software products to provide total solutions for our clients. LabAnswer is expert in architecting, configuring, deploying, validating and supporting laboratory systems. These systems include LIMS, ELN, SDMS, and CDS, among others.…

Sparta Systems Partners with Navitas to Provide Comprehensive Solution for IDMP Compliance

Sparta Systems, Inc., an industry pioneer and a global leader in enterprise quality management software (EQMS) solutions, and Navitas, a leading global consulting, business process outsourcing and technology provider, today announced an integrated solution for life sciences organizations that will enable compliance with the upcoming Identification of Medicinal Products (IDMP) regulations, to be finalized by the European Medicines Agency (EMA) in early 2017.

Business Analyst

The Business Analyst will be responsible for working with customers/end users to understand their business processes and gather functional requirements in order to configure and customize their new LIMS systems. The BA will work with both customer stakeholders and internal resources to insure best solution is delivered to meet customer requirements.…

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