Web Content Management
PRODUCTS
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The quality testing of medical device packaging is highly significant in ensuring the safe delivery of medical devices from their place of origin to the market. Guidance documents such as ISO 11607 provide a list of methods that have the capability to improve the package quality testing of today’s capability. PTI offers inspection methods that provide more reliable, sensitive, and traceable data. They offer in-depth feasibility studies, test method development, and test equipment to bring the supreme level of quality to high-value medical device applications. PTI’s inspection solutions are unique in their performance, reliability, and use of sensory technology.
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Ensuring your computer software system validation efforts associated with manufacturing data workflow and materials management operations is our priority.
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Increase efficiency with fast and simple two-way data sharing between the Sartorius Ambr® 250 and Waters BioAccord LC-MS System.
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Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
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The BeamSquared® system is a compact and fully automated tool for measuring the propagation characteristics of CW and pulsed laser systems from the UV to NIR to Telecom wavelengths.
WHITE PAPERS AND CASE STUDIES
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CDMO Supports Complex Bispecific Antibody Development
Read how the expertise, resources and flexibility of one partner have been fundamental in advancing novel and complex bispecific antibody candidates that target the WNT pathway.
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How To Save 9k Hours And Cut Deviations By 27%
This pharma company transitioned off paper, slashing their deviation count and saving thousands in onsite hours. Learn how they were able to streamline business operations and free up resources.
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Managing Complex Global Drug Distribution And Expiry
A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.
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Advantages Of Using POD Cleanroom Technology
With recent rapid market growth, demand has increased for flexible alternatives to centralized manufacturing. Having a full-scale GMP facility for each new therapy is implausible yet most facilities are not equipped with the flexibility required to manufacture multiple products. Learn about the advantages of flexible, pre-fabricated modular cleanrooms that are built offsite and delivered as a product to the customer site.
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End Of End Point Assays: SPR Analytics In Vaccine Design, Development
Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
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Municipal Utility Builds An Asset Management Foundation In The Cloud
A Massachusetts municipal electric utility wanted an easier, more user-friendly way to maintain, understand, and utilize asset information. Realizing that digital transformation was within reach, the utility chose cloud-based software that contains applications and dashboards to support collection, inventory, and management of assets in its electric distribution network. Centralized real-time information enables the utility to update records upon inspection and respond quickly to unexpected events like outages.
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R&D Services Company Implements A Collaborative Electronic Lab Notebook
For a this BIOVIA customer, meeting collaboration demands meant being able to rapidly collect project information to deliver reports and data, fulfill patent submissions, or leverage and build on past work.
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Biotech Enables Accelerated Scale-Up Of A Spray-Drying Program
A virtual biotech, focused on the development and commercialization of a product to treat advanced solid tumors, partnered for the development, clinical trial supply, and scale-up of a spray-drying program.
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Nevro Eliminates Majority Of Source Data Verification With ePRO And EDC
Read how a global medical device company was able to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments.
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Hospital Researchers Turn To Corning To Help Scale Up Ex Vivo Expansion Of Adipose Stem Cells
Autologous fat grafting is the least invasive method for breast reconstruction, but also has major drawbacks, including high tissue resorption rates of up to 80%. Researchers in Denmark had a hypothesis: what if you could enrich the human fat graft with autologous adipose stem cells (ASCs) to increase graft survival? But they faced a major obstacle: how do you culture a sufficient volume of stem cells to increase grafting success? They turned to Corning, who designed a scale-up solution that’s enabling them to grow the billions of stem cells required to move forward with this clinical study.
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How To Enroll 612 Patients In A Neurology Study On Time And Within Budget Despite Hurdles Caused By The Pandemic
In the available case study, learn how a leading Indian pharmaceutical manufacturer and an Eastern European CRO launched a Ph3 neurology study within an impressive seven months.
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Set For The Future—San Juan Water Implements Esri's ArcGIS Utility Network And Cityworks Computer Maintenance Management System
San Juan Water District (SJWD) has used ArcGIS Utility Network as a foundation for the organization's computer maintenance management system (CMMS) implementation, which uses Cityworks. The Utility Network and the CMMS work from one centralized database for water distribution. The field crews can access the latest information and use the networking analysis capabilities for outage events via tablets in the field or a web browser in the office. The integration of these systems has improved reporting and inspection workflows while providing a single, authoritative source of truth.
NEWS
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Triall Partners With Crucial Data Solutions To Realize The World's First End-To-End eClinical Platform Powered By Blockchain3/24/2022
Triall, a tokenized platform for blockchain-enabled clinical trial technology, has partnered with Crucial Data Solutions (CDS), an eClinical software provider that offers a range of specialized applications for clinical trial data collection and management.
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PathogenDx Announces The CE Marking Of Its Next-Generation COVID-19 Testing Technology For The Simultaneous Detection Of SARS-CoV-2 (COVID-19) And Its Variants2/2/2022
PathogenDx, a U.S.-based biotechnology company that is setting the standard in molecular testing through the widespread adoption of its innovative DNA microarray testing platform for the human diagnostics, food and agricultural industries, announced that its next-generation COVID-19 test technology, the Detectx-Cv+ test, has been CE marked in accordance with the requirements of the European Parliament and Council Directive 98/79/EC on in vitro diagnostic medical devices ("IVDD")1.
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B. Braun Receives FDA Approval Of Daytona Beach Pharmaceutical Manufacturing Site1/31/2022
The site will produce 0.9% Sodium Chloride for Injection available in B. Braun's Excel® Plus IV Bags in 1,000 mL and 500 mL sizes.
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Orgenesis Reaches Next Milestone In Collaboration With Hospital Infantil Universitario Niño Jesús In Madrid1/27/2022
Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today announces it has achieved its latest milestone in the second phase of its collaboration with the Hospital Infantil Universitario Niño Jesús (“Hospital”) in Madrid, Spain.
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Cardinal Health Launches Stray Away Hair Management Drape In Collaboration With MedStar Health's Institute For Innovation4/19/2023
Cardinal Health announced today the launch of the first-of-its-kind Stray Away™ hair management drape for more efficient surgical procedure preparation.