Compliance

WHITE PAPERS AND CASE STUDIES

• 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?

• FoodTronix/PathwayLINK Case Study FoodTronix is a Dallas, Texas-based provider of "economical yet secure" POS solutions and a suite of technology products to restaurant market.
• Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

  Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

• 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.

• Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

  A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

• USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
• 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.

• 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
• 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.

• 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
• Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner

  In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.

• Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

  Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.