Compliance

PRODUCTS

  • Versatile CCIT1 for a wide range of applications

    The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.

  • The SamuxMP Auto is the automated mass photometer for AAV characterization, autonomously measuring up to 24 samples in approximately 90 minutes. The instrument rapidly measures AAV empty/full ratios, sample purity and particle aggregation for any AAV serotype – with high precision and reproducibility.

  • If you need robust and reliable fill-finish equipment that causes minimal disruption to your existing footprint, the Hull i-Dositecno LI Versa-Line™ Pharmaceutical Filling equipment is here to help! Accessibility from one side means you can install at the wall for a linear filling and capping system that fits neatly into any space.

  • The QPA0016 is a high-power, packaged Ku-Band MMIC amplifier fabricated using Qorvo's 0.15 um GaN-on-SiC process.

  • Our comprehensive package of both autologous and allogeneic cell therapy manufacturing services includes GMP production of cells from pre-clinical to commercial applications from a variety of starting materials. As an experienced cell therapy CDMO, we’re able to swiftly scale-up and support production from clinical to commercial manufacturing. Need help with the development of your cell therapy?

WHITE PAPERS AND CASE STUDIES

  • Graniterock Speeds Up Reporting From 7 Days To Real Time

    Graniterock is one of California's premier construction materials producer, delivering hot mix asphalt, recycled asphalt, concrete and other materials to roads, highways, runways and bridges from San Francisco to Monterey. Safety is a core value at Graniterock, and the company requires employees to adhere to safe work practices at all times. The company wanted to update its slow, paper-based process for equipment and safety inspections to a more efficient solution based on mobile devices and cloud-connected services.

  • 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.

  • 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.

  • Protecting Cardholder Data In The Enterprise Retail Market Merchants are feeling increased pressure from credit card companies to comply with security regulations such as the Payment Card Industry (PCI) Data Security Standard (DSS) and Payment Applications Best Practices (PABP) and are being offered incentives to comply or facing harsh penalties for not complying. Submitted by IP Commerce
  • 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).

  • Eliminating Data Integrity Errors Through Digitization

    Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

  • Safety First In The Field!

    Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.

  • Checkmate International Assures Food Safety Compliance with PointBase Micro Originally, Checkmate relied on a proprietary data storage structure, written specifically to run on Psion computing devices. However, this became difficult to integrate with corporate back-end databases and was prone to data corruption. To resolve these problems, Checkmate has now switched to PointBase Micro, a platform-independent relational database optimized for mobile environments.
  • California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
  • 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.

  • How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency

    With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.

  • 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

NEWS