Compliance
PRODUCTS
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Take control of your production by tracking every part, assembly, and batch with precision.
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Eurofins PSS Insourcing Solutions provides biotech, pharmaceutical, and CDMO organizations with embedded regulatory expertise that strengthens compliance, accelerates timelines, and ensures audit readiness—without adding headcount. With over two decades of insourcing experience and a global footprint across 110+ client sites, PSS delivers strategic, on-site support tailored to each client’s regulatory landscape.
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Preparing regulatory marketing applications to their successful conclusions is our focus.
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Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity
Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.
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Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
WHITE PAPERS AND CASE STUDIES
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Pharma And Biotech: How Labs Achieve Data Integrity
Learn from an industry expert how important it is for companies to be compliant with data integrity and to ensure the trustworthiness and reliability of electronic records.
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FoodTronix/PathwayLINK Case Study FoodTronix is a Dallas, Texas-based provider of "economical yet secure" POS solutions and a suite of technology products to restaurant market.
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Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours
The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.
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Case Study: DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
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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.
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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.
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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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Catalent's Journey Of Continuous Improvement For CSV Excellence
Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.
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Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
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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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Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration
A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.
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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.
NEWS
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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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KPA Flex Software Enhances Construction Safety And Compliance With Advanced Features5/6/2024
KPA, a leading provider of Environment, Health, and Safety (EHS) compliance solutions, announced the release of new features in the KPA Flex software platform that are specifically tailored for construction safety programs to streamline efficiency, increase real-time visibility, and foster a robust safety culture.
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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.
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Dayforce Continues Global Momentum With Launch Of Dayforce Payroll In Singapore5/29/2024
Dayforce, Inc. (NYSE: DAY; TSX: DAY), a global human capital management (HCM) leader that makes work life better, today announced the introduction of its industry-leading payroll capabilities to the Singapore market with the launch of Dayforce Payroll for Singapore.
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With Click Rate Analysis, The R&S EPL1000 EMI Test Receiver Is The Cost-Effective Answer To CISPR 14-1 Compliance Testing3/1/2024
For both device developers and conformance test houses the R&S EPL1000 EMI test receiver offers fast, accurate and reliable EMI compliance measurements up to 30 MHz at the best price in its class. The R&S EPL1000 now adds click rate measurements in line with the latest CISPR 14-1:2020 version, mandatory for household appliances and electric power tools.