Compliance
PRODUCTS
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PHCbi brand’s 48.0 cu.ft. refrigerator with 10 solid pull-out drawers and forced-air circulation help helps ensures uniform temperature at all levels. The vertical airflow system delivers fast recovery after door openings, maintaining stability even in high-traffic environments. The automatic cycle defrost system minimizes temperature fluctuations while reducing maintenance. 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.
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Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward
Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.
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Ensuring you have equipment that accurately and rapidly assembles syringes and cartridges is crucial to the success of your pharmaceutical manufacturing workflow. The Hull i-Dositecno SY pharmaceutical labeling machine harnesses dual-function robotics for plunger insertion and labeling to ensure the safety and sterility of your product.
- Versatile – ideal for syringes or cartridges in sterile, clean, ready-to-fill (SCF) tubs
- Cleanroom ready
- Fully compliant – 21 CFR Part 11 software and IQ/OQ validation packages available
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Help your patients make informed decisions without burying them in paper
With electronic informed consent (eConsent) software, your patients can access consent forms using any device they choose. And because it’s part of TrialKit’s unified platform, both your patients and your study team get a seamless experience.
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For a nasal spray production fill-finish solution that offers unparalleled versatility, look no further! The Hull i-Dositecno BI and MI Nasal Spray Filling Machines simplify your manufacturing workflow to enable accurate and consistent rotary filling, stoppering and capping. With simple servo-driven motion-controlled design they can fill up to 50 or 200 units per minute (upm).
WHITE PAPERS AND CASE STUDIES
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How To Survive An FDA Audit
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
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X-Ray Inspection For Supplement Safety
Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.
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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
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Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.
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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
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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.
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Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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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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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.
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A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program
Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.
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Developing An Organizational Roadmap For Post Authorization Safety Studies
Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.
NEWS
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Asimily Achieves SOC 2 Type II Certification And C5 Attestation, Strengthening Global Compliance Leadership In IoT And OT Risk Management8/14/2025
Asimily, the only complete IoT, OT, and IoMT risk mitigation platform, today announced it has achieved both SOC 2 Type II certification and C5 attestation, two globally recognized benchmarks for security, privacy, and operational excellence.
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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.
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ABB Leads In Emissions Monitoring With Industry-First Data Acquisition System Proficiency Test12/5/2024
ABB’s CEM-DAS is the first data acquisition and handling system (DAHS) on the market to successfully pass testing in line with EN 17255, the first international standard for DAHS in emissions monitoring.
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iDox.ai Announces Launch Of iDox.ai Privacy Scout: AI-Powered Solution That Goes Beyond DLP To Protect Sensitive Data In Real Time7/22/2025
iDox.ai, a U.S.-based provider of AI-powered document compliance tools, announces the launch of iDox.ai Privacy Scout, an advanced Data Loss Prevention (DLP) solution engineered to detect and protect sensitive information in real time, particularly in environments deploying Generative AI.
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Paperless Innovations' Solutions Now Available On Carahsoft's GSA Schedule And Additional Contract Vehicles2/22/2024
Paperless Innovations, Inc., the leading provider of government purchase card (GPC) compliance automation solutions, and Carahsoft Technology Corp., the Trusted Government IT Solutions Provider®, today announced that Carahsoft has added Paperless Innovations’ GPC compliance automation products to its GSA Schedule.