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 NanoAssemblr® commercial formulation system is an automated, single-use system for the clinical and commercial production of lipid nanoparticles (LNPs) under cGMP conditions. Designed for efficient changeover and robust manufacturing processes, the system enables operational flexibility and standardized manufacturing of genomic medicines.

  • Treat nearly any room or area in your facility with this mobile, scalable system. Ecolab’s Bioquell ProteQ features wireless communication technology, built-in aeration, and the option to add additional aeration capability.

  • PHCbi brand's 48.2 cu.ft., refrigerator with 8 adjustable shelves and a forced-air circulation for maximum temperature uniformity at all levels. Unique electronic defrost cycle initiates defrost function automatically, minimizing temperature fluctuation during the process. The temperature control system, with a microprocessor, maintains true temperature at the set level and is unaffected by outside ambient temperature. Audible and flashing LED visual alarms alert the user to the unlikely event of either a high or low temperature status. High performance refrigeration system with reserve cooling capacity assures fast recovery following door openings.

  • PHCbi brand’s 23.7 cu.ft (671 L) upright pharmaceutical refrigerator offers a high-capacity solution for clinical and biomedical storage. Five pull-out drawers provide organized access, while fan-forced air circulation help helps ensures uniform temperature control from 2°C to 23°C. A microprocessor system with alarms helps maintain stability and safety. The shelves can be arranged to accommodate different configurations. The unit is deep and strong enough to hold processing equipment and most devices. It offers optimal performance without compromising efficiency.

WHITE PAPERS AND CASE STUDIES

  • Maximize Output From Full-Time Employees

    Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.

  • GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
  • 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
  • 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.

  • Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
  • 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
  • ARMA 2005 Show Highlights Refined Solutions For Records Managers The message to attendees of this year's ARMA show was to engineer an easy transition from paper-based files to electronic records management, supported with a clear and calculated plan. ARMA provided me a chance to sit down and talk with ECM vendors about the special offerings they had for solving companies' records management needs. Check out some of news and highlights from the manufacturers and software providers that were at the show.
  • WIMAX With Differentiation By Elvis Tucker, Aperto Networks The WiMAX Forum defines the profiles that any WiMAX-compliant broadband wireless access systems must support in order to achieve inter-operability. But while inter-operability is an important goal for any WIMAX-compliant system, it will not ensure optimization. Submitted by Aperto Networks

  • Managing Hospitality And Entertainment Spending The ability for hospitality and entertainment enterprises to effectively source, procure, and manage their spend must keep pace with the demand for promptness and compliance in supplier relationship management (SRM). Submitted by Epicor Software Corporation
  • Q&A: Payment Processing With Precidia Technologies Precidia has issued several press releases, through late 2008 and early 2009 regarding the TransNet solution. What is your strategy with this product? In introducing TransNet, we are offering the market an alternative to the established integrated payment model. Our solution addresses some of the limitations of the...
  • Expectations On The Pathway To GMP For Gene-Modified Cell Therapies

    Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

  • Focus On Your Core Business Strategy

    Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.

NEWS