Compliance
PRODUCTS
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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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An ultra-compact, and fully configurable, aseptic crimping platform, with capping force measurement, designed to help customers develop and manufacture new drugs and devices at low risk.
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Biotech companies progressing through clinical trials, planning an IPO, and undergoing rapid growth have a unique set of financial, contract, compliance, and reporting needs. We have designed an ERP solution, built on NetSuite, to address all of these needs. With over 50 implementations in the last two years alone, SuiteSuccess for Life Sciences is quickly becoming the defacto software standard for all successful biotechnology companies.
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This easy-to-use process analytical technology device offers in-line bioprocess analysis and control with no complex modeling. Measure multiple critical parameters across media, across processes, across mammalian cell lines, across scales.
All In-line Gain, No Modeling Pain
MAVERICK is powered by Raman spectroscopy and a purpose-built de novo model. The de novo model is explicitly built on media chemistries and device physics, not on empirical data. It automatically interprets the spectra and quantifies process parameters enabling simultaneous measurements of glucose, lactate, and total biomass. This is achieved without the costs, complexities, and risks associated with conventional Process Analytical Technology (PAT) methods. There is no need to grapple with complex empirical models, reagents, or unreliable auto-sampling systems to implement in-line bioprocess analysis.
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Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.
WHITE PAPERS AND CASE STUDIES
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New EH&E White Paper Evaluates Web-based Environmental Health & Safety Training For Laboratory Applications A new free white paper entitled “The Role of Web-based Health and Safety Training in Laboratory Facilities,” is available to help companies, institutions, and universities evaluate the efficacy of using web-based environmental health and safety (EH&S) training to meet their compliance requirements
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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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Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Case Study: Physicians Medical Group
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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.
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The Importance Of Quality In Raw Material Selection
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
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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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Pharma Manufacturing: Top 10 Pitfalls To Avoid
Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?
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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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Comparative Analysis For Non-IND Sites
A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.
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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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The Potential Return On Investment Of Using ePROs Over Paper In Clinical Trials
Industry perception is that the start-up costs of implementing an ePRO platform may dwarf the cost of printing and distributing paper diaries by as much as 10 times. However, this does not take into consideration the significant value and return on investment that adopting ePRO technology has had on overall clinical trial costs and timelines due to improvements in data quality and completeness, participant retention and compliance, and study and site efficiency.
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White Paper: The Impact Of The Internet On Compliance Education I sat with astonishment as the compliance officer of a large corporation told me that he had no idea what compliance education was being performed on a day-to-day basis within his organization. He went on to indicate that his company could not produce reliable documented evidence that its employees had in fact, completed federally mandated education
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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SignWell Launches NOM-151 Compliant E-Signatures In Mexico12/9/2025
Businesses across Mexico now have a more straightforward, more affordable way to sign documents online legally. SignWell, a leading e-signature platform trusted by over 65,000 businesses globally, is now officially offering NOM-151-compliant electronic signatures, ensuring legal validity under Mexican regulations.
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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.
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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.