Compliance

PRODUCTS

  • Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.

  • Ideal for biotherapeutic protein production in suspension CHO cells, the CHOgro expression medium is a chemically defined, hydrolysate-free and animal-origin-free medium.

  • A strong risk and quality control strategy is essential to ensuring the safety, efficacy, and consistency of pharmaceutical manufacturing. By identifying and addressing potential risks early, we prevent costly errors and delays, ensuring smooth and efficient manufacturing of your products.

  • Eurofins PSS Insourcing Solutions is a strategic, compliant, and stable alternative to traditional staffing models, enabling biotech, pharmaceutical, and CDMO organizations to meet operational demands without increasing internal headcount or exposing themselves to co-employment risk. As a managed service provider, PSS hires, trains, and manages scientific personnel who perform defined scopes of work directly at client sites—fully integrated into client operations yet fully employed by Eurofins.

  • Implement Software Solutions that Support and Enhance Your Mission

    Whether you’re heading toward clinical trials or on the path to commercialization, implement technology infrastructure that keeps pace. The last thing you need in a fast-moving industry is for your business management solutions to lag behind.

    As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. Sikich has helped over 250 Life Sciences companies grow from pre-revenue to commercialization quickly and painlessly.

WHITE PAPERS AND CASE STUDIES

  • Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  • Adopting Label Change Best Practice To Promote Clarity And Compliance

    Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

  • Can Your Biopharma Team Keep Unplanned Downtime At Bay?

    Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.

  • Sanford, FL Upgrades Water Treatment With Pinnacle Zenith 30X™ Ozone Generator

    Sanford, Florida modernized WTP#2 with Pinnacle’s Zenith 30X™ ozone system, removing color, odor, DOC, and H₂S while improving energy efficiency and regulatory compliance.

  • Software Automation In The Blood And Biologics Industry

    Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

  • White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.
  • Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  • 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
  • Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies
  • Case Study: 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.
  • Intelligent Workflow From Farm To Processing At Dobler & Sons

    Dobler & Sons has incorporated a fleet management system to comply with the recent ELD mandate and to improve overall efficiency in managing it’s fleet and team of drivers.

NEWS