Compliance
PRODUCTS
-
Navigating the technical challenges of mAbs production and scalability
Monoclonal antibodies (mAbs) offer promising immunotherapy treatments, targeting antigens and diseases. Manufacturing these complex therapies presents challenges in scaling up, cost, and consistency. Germfree’s expertise in tailored cleanroom solutions addresses these obstacles, ensuring sterility and seamless equipment integration. By providing advanced facilities for both small-scale clinical trials and larger-scale production, Germfree contributes to the successful development and commercialization of mAbs, ultimately improving patient outcomes and transforming healthcare landscapes.
-
Whenever possible, Mueller tailors product certification to match specific job requirements, including part numbers, job identification, and funding agency requirements. We have developed this process working closely with the Environmental Protection Agency (EPA) who was very early in clarifying definitions and requirements for Iron & Steel Products, Construction Materials, and other Manufactured Products.
-
The MBAL-0250CSP2 is a passive monolithic microwave integrated circuit (MMIC) 1:2 balun developed by Marki Microwave, designed to operate across an exceptionally wide frequency range of 2 to 50 GHz.
-
Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems.
-
Engineered from the ground up following the latest Annex 1 revision. With 100% level of quality inspection and advanced reject management, roboFIL™ enhances quality assurance, supporting a robust Contamination Control Strategy (CSS).
WHITE PAPERS AND CASE STUDIES
-
Set Up And Qualify GMP Laboratories
See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.
-
Hospitality POS Reseller Relies on Mercury Payment Systems to Stay Ahead of the PCI Curve Partner education helps reseller overcome merchant objections.
-
California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
-
The Importance Of Quality In Raw Material Selection
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
-
Ensuring Compliance With Part 11: A Site's Perspective
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.
-
Support Manufacturing Operations With Process Data Management Software
Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).
-
Hyland Software Customer Rochdale Metropolitan Borough Council Presents At Butler Group Enterprise Content Management Symposium In London Hyland Software, Inc., developer of the OnBase enterprise content management (ECM) software suite, announced that Hyland customer Rochdale Borough Metropolitan Council presented a case study regarding its installation of OnBase at the Butler Group Enterprise Content Management Symposium.
-
Mobile-Enabling Logistics: Turning The “Last Mile” Into Aa Competitive Advantage
When it comes to supply chain, the final process of actually delivering the goods can make or break a company. The impact associated with the delivery process affects margins, customer relationships, repeat business, and cash flow. The paper-laden delivery confirmation process often involves capturing key data and customer signatures, and then handing the paperwork to an admin for processing once the drivers are back at the office. This greatly impacts time to invoice, receiving of cash, revenue recognition compliance, and data quality.
-
A Guide To Pharmaceutical Quality Management
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
-
Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours
The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.
-
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.
-
Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
NEWS
-
Rohde & Schwarz And U-Blox Validate Module Compliance With The New Chinese GNSS Automotive Specification GB/T2/26/2025
u-blox, a leading global supplier of GNSS modules, and Rohde & Schwarz have successfully validated ublox’s latest automotive GNSS module in accordance with the recently published Chinese GB/T test requirement for automotive on-board GNSS positioning systems using an automated R&S SMBV100B based GNSS simulator solution. This cutting-edge solution will be demonstrated at Mobile World Congress 2025 in Barcelona.
-
Incora's Global Chemicals Business Introduces Use Of RFID Technology To Enhance CMS Offering7/11/2024
Incora, (collectively, “Incora” or the “Company”), a leading global provider of innovative supply chain management solutions, is proud to announce an enhancement to the Company’s Chemical Management Services (CMS) solution offering, incorporating Radio-Frequency Identification (RFID) technology into the Company’s Total Chemical Management Information System (TCMIS).
-
Gnosko Launches RFID-Integrated Chain Of Custody Platform To Help Labs Do More With Less5/20/2025
As laboratories face shrinking research budgets, government funding cuts, and increasing compliance demands, Gnosko is stepping up with a timely solution: a cost-effective, RFID-integrated Chain of Custody (CoC) platform that automates sample tracking, inventory management, and regulatory reporting.
-
Sage & Mitratech Partner To Simplify Compliance With HR Advice Offering5/23/2024
Sage, the leader in accounting, financial, HR and payroll technology for small and medium-sized businesses (SMBs), today announces a new partnership with Mitratech’s Mineral, a leading HR and compliance platform serving more than 1 million SMBs.
-
BlueFletch Pioneers Integration With Microsoft's QR Code + PIN Authentication For Frontline Workers2/25/2025
BlueFletch, a leading provider of secure enterprise mobility solutions, announces its pioneering integration with Microsoft's QR Code + PIN authentication method.