Compliance
PRODUCTS
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Purpose-built with users at the center to make it easier and more efficient to get quality patient outcomes data for submissions and approvals.
Collecting quality data on patient outcomes is often one of the most important parts of a clinical trial. It is also challenging, and many eCOA solutions make it feel even more difficult with complicated processes, lack of questionnaire reusability, slow set up, and difficult to use tech.
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Streamline Your Media Preparation and Column Packing
At Asahi Kasei Bioprocess, we understand the importance of efficient and reliable slurry preparation for successful purification processes. With that in mind, we have developed the SLURIPREP line of media management products to simplify your resin preparation and packing, specifically designed for DAC LC Columns. Our comprehensive range of accessories ensures that your column operation is seamless, efficient, and optimized for high productivity.
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With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials.
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25 years of Providing World-Class Medical Information Services.
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Single-Use System
The UFMini is a single-use centrifuge designed for primary clarification of mammalian cell cultures (i.e., CHO cells), and harvesting (washing & concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications. This user-friendly system is the scaled-down version of our successful UniFuge® single-use centrifuge. The UFMini is intended for use in cleanrooms, in laminar flow hoods, and on benchtops.
- Bowl capacity: 300mL
- Flow rate from 29-1,000 mL/min
- Small footprint: Centrifuge Enclosure 69 cm x 56 cm x 38 cm (27” x 22” x 15”)
- Easy to handle: Total skid weight of ~40 kg (90 lbs)
- Gamma-irradiated single-use modules
- Processes scalable to UniFuge® Pilot and U2k®
WHITE PAPERS AND CASE STUDIES
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Regulatory Compliance: Weighing In Pharma Manufacturing
Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.
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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.
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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.
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Sporting Goods Retailer Takes Safety And Product Testing To A New Level
This U.S.-based retailer is an omni-channel sporting goods powerhouse offering a broad assortment of top-brand sporting goods equipment, apparel and footwear. They operate 645 locations with a blend of dedicated associates, in-store services and unique specialty shop-in-shops. As a producer of reliable, high-quality products that their loyal customers have come to expect, product safety and compliance are major focuses for this sporting goods retailer.
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AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
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Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
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Serialization And Traceability Compliance In Pharma And Med Device
Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.
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How Sharp Packaging's Clinical Packaging Process Is 30% Faster
Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.
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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
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Overcoming Obstacles To Deliver Critical Autologous Cell Therapy
See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
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Case Study: Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
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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).
NEWS
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AppTec360's Advanced Mobile Content Management Solutions Reinforce Enterprise Security3/11/2025
Data security remains a critical concern for organizations as the risk of breaches and unauthorized information sharing continues to rise. Addressing these challenges, AppTec360 introduces ContentBox, a Mobile Content Management (MCM) solution designed to enhance security while enabling seamless file synchronization and controlled data access.
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SwiftComply Launches Next-Gen Pretreatment Module, Setting A New Standard For Water Compliance6/18/2025
SwiftComply, the software platform built specifically for water utility compliance, today announced the launch of its new Pretreatment module, a specialized, smart system for managing industrial wastewater oversight.
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Sentinel Water Solutions And DESOTEC Announce Partnership To Provide NSF-Certified GAC Reactivation Services8/26/2025
Sentinel Water Solutions (Sentinel), a leader in PFAS pilot testing and treatment, today announced an exclusive channel partnership with DESOTEC, one of the world’s leading providers of sustainable activated carbon solutions, to deliver NSF-certified granular activated carbon (GAC) reactivation services for U.S. drinking water utilities.
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Selkirk Pharma Announces New APS Qualified Facility With Advanced Fill/Finish Capacity In Spokane, WA2/15/2024
Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity.
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Curia Invests $4M To Enhance Sterile API Manufacturing10/27/2025
Curia, a leading global research, development and manufacturing organization, today announced the completion of a $4M investment to upgrade its two API aseptic suites in Valladolid, Spain.