Compliance

WHITE PAPERS AND CASE STUDIES

• Osmolality: A Powerful Tool In Bioprocessing

  Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.

• 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
• 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
• Preparing For Post-Market Clinical Follow-Up Under EU MDR

  Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

• 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?

• An Equitable Way To Meet On-Site Business Needs

  Tackling high turnover and employee equity challenges is a priority. Learn how an on-site insourcing solution can provide a stable and motivated team, ensuring project success.

• 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.

• 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.

• Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
• 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.

• Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
• Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx