Compliance

PRODUCTS

  • 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.

  • 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.

  • 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®
  • 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.

  • 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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