Compliance

WHITE PAPERS AND CASE STUDIES

• 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.

• Regulatory Compliance: Weighing In Pharma Manufacturing

  Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.

• Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing

  Discover how adhering to strict GMP guidelines and advanced equipment design ensures that complex, sterile cell and gene therapies are safely and effectively delivered.

• A Guide To Pharmaceutical Quality Management

  Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

• 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
• Ensuring Compliance With Part 11: A Site's Perspective

  As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

• Fire And Life Safety And Security Industry

  New government regulations and the need to update outdated or non-compliant technology are requiring building owners and facilities managers to think about upgrading their fire alarm, security, and fire suppression systems with the latest technology available.

• Serialization And Traceability Compliance In Pharma And Med Device

  Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

• 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).

• Q&A: Payment Processing With Precidia Technologies Precidia has issued several press releases, through late 2008 and early 2009 regarding the TransNet solution. What is your strategy with this product? In introducing TransNet, we are offering the market an alternative to the established integrated payment model. Our solution addresses some of the limitations of the...
• Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot

  Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research 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