Compliance
PRODUCTS
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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 robotic capsule filler, part of the Explore Range, integrates our award-winning Fill2Weight technology, eliminating ‘formulation for filling’ steps and reducing pre-clinical timescales, fast tracking to Phase III.
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Single-Use System
The UniFuge® Pilot uses a gamma-irradiated, single-use module to eliminate cleaning needs. It is designed for primary clarification of mammalian cell cultures (e.g., CHO cells), and harvesting (including washing and concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications.
- Bowl capacity: 1.8 L
- Flow rate from 1-4 L/min (higher flow rates may be achieved, based on application)
- Small bench top footprint: 61 cm wide x 99 cm deep x 117 cm high (24” x 39” x 117”)
- Easy to handle: Total weight ~ 291kg (640 lbs) - Easily movable with stainless steel casters leveling on skid with vibration isolators
- Gamma-irradiated single-use modules
- Scale processes up with the U2k® or down with the UFMini®
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The most widely trusted solution for clinical trial disclosure management
Managing clinical trial disclosures can be tedious and error-prone, opening the door to noncompliance. TrialScope Disclose provides a better way.
Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.
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ISOPRIME Isolators
ISOPRIME is the ideal solution for customers with modular rigid-wall isolator requirements that combine high quality, versatility, and continuous operations at a competitive price point.
WHITE PAPERS AND CASE STUDIES
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Software Automation In The Blood And Biologics Industry
Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.
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Demanding More From AI Governance In Drug Safety
Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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Delivering Apheresis Treatment From The USA To The UK Within 24 Hours
The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
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Pharma Manufacturing: Top 10 Pitfalls To Avoid
Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?
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Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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Malware Creativity Means VAR Opportunities To highlight the market opportunities for VARs, PC Tools released the findings from a worldwide survey of more than 25,000 respondents — of which 12,307 were from the United States. By Business Solutions magazine
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Making Money With Security Awareness Training
How addressing human error reduces risk and bolsters your profitability.
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Ensuring On-Time Release Of CAR-T Cell Treatment In Spain
Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.
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Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant
Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.
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How An MSP Enhances Compliance For Healthcare And Finance Clients
Eric Gaffin is the Director of Cybersecurity and Compliance Services for Advanced Technology Group, a managed security and IT services company with a 20-year track record of delivering cutting edge solutions to clients in heavily-regulated industries. See how he’s using ActivTrak to address his clients’ compliance needs.
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USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
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Preparing For Post-Market Clinical Follow-Up Under EU MDR
Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.
NEWS
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SignWell Launches NOM-151 Compliant E-Signatures In Mexico12/9/2025
Businesses across Mexico now have a more straightforward, more affordable way to sign documents online legally. SignWell, a leading e-signature platform trusted by over 65,000 businesses globally, is now officially offering NOM-151-compliant electronic signatures, ensuring legal validity under Mexican regulations.
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Paperless Innovations' Solutions Now Available On Carahsoft's GSA Schedule And Additional Contract Vehicles2/22/2024
Paperless Innovations, Inc., the leading provider of government purchase card (GPC) compliance automation solutions, and Carahsoft Technology Corp., the Trusted Government IT Solutions Provider®, today announced that Carahsoft has added Paperless Innovations’ GPC compliance automation products to its GSA Schedule.
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GPS Now Offers Safety Training For Enhanced Workplace Compliance2/22/2024
GPS, the leading employment navigator, is proud to announce the addition of safety training to its list of services.
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MangoApps Adds AI-Powered Scheduling & Shift Swap To Its Extensive Workplace Operations App Marketplace7/15/2025
MangoApps today announced powerful new enhancements to its workplace operations platform, introducing AI-powered scheduling and intelligent shift swap capabilities.
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R2 Recycling Makes E-Waste Recycling Simple And Hassle-Free For New York City9/12/2025
R2 Recycling, a trusted name in responsible electronics recycling, is proud to announce expanded, hassle-free e-waste recycling services across all five boroughs of New York City.