Compliance
PRODUCTS
-
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).
-
The QPA0016 is a high-power, packaged Ku-Band MMIC amplifier fabricated using Qorvo's 0.15 um GaN-on-SiC process.
-
PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model
-
When it comes to your fill-finish workflow, sterility and efficiency are key. Denest and renest with confidence! Our ready-to-use (RTU) denesting equipment is here to help you separate and reassemble your products with ease. Rest assured the Hull i-Dositecno Denesting Equipment is robust and efficient, so your sterile, clean, ready to fill (SCF) components are transported smoothly through your fill-finish workflow.
-
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
-
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.
-
Petzl America Ascends To The Next Level Of Distribution Petzl America, a leading distributor of climbing, mountaineering and safety equipment, needed to streamline distribution operations in order to continue to meet customer compliance requirements and changes in order fulfillment characteristics. Submitted by Cornerstone Solutions
-
GFI Case Study: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
-
Case Study: Success Of Saipan's Solid Waste Management System Serving As Example To Other South Pacific Islands An integrated solid waste management system implemented on the island of Saipan has proven so successful that other neighboring South Pacific islands may follow suit. The goal for a new solid waste system was to not only bring Saipan into compliance with federal environmental regulations, but also utilize state-of-the-art waste reduction and diversion technologies
-
Case Study: Excavating Company Gains Environmental Compliance For Vehicle Wash Water Brownsville, Penn.-based, Brubacher Excavating, Inc. performs a full range of excavating, pipe and utility installation, roadway construction, general earth moving activities and related site development services in Southeastern Penn. Although the company washes its heavy equipment regularly, its dump trucks and tractors account for the most frequent use of its wash bay.
-
Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
-
Osmolality: A Powerful Tool In Bioprocessing
Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.
-
Aligning Competing Interests While Optimizing The Service Chain In The Transportation Sector
This paper explores convergence in detail, starting with a breakdown of the service chain into its key components. We then discuss the obstacles and inherent consequences of inadequate efforts in each of these areas before presenting a model that helps set transportation companies up for success in service chain optimization.
-
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.
-
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
-
Successfully Delivering Critical Stem Cell Samples Across The Globe
To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.
-
24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments
Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.
NEWS
-
airSlate SignNow And Paperwise Partner To Redefine eSignature And Workflow Automation3/10/2025
airSlate, a global leader in electronic signature and document workflow automation, is excited to announce a new integration and reseller partnership with Paperwise, a premier provider of process automation and document management solutions.
-
Recipharm Expands Aseptic Filling Capabilities For Process Development, Pilot Scale And Clinical Supply2/5/2025
Recipharm, a leading global contract development and manufacturing organisation (CDMO), has announced that a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its state-of-the-art facility in Wasserburg, Germany.
-
Rohde & Schwarz Launches High-Flexibility EMI Test Receivers At EMV2025 Paving The Way For Optimized Investments3/20/2025
The new EMI test receivers R&S EPL1001 up to 1 GHz and R&S EPL1007 up to 7.125 GHz offer engineers a flexible and cost-effective solution for EMI measurements.
-
Zipline Announces UKG Partnership Enhancement6/17/2025
Zipline, the leading platform for frontline execution and communication, today announced a major enhancement to its UKG integration. With this release, frontline employees can now confirm key compliance-related details directly in Zipline during clock-in and clock-out, with the information syncing seamlessly to UKG’s existing attestation workflows.
-
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.