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Life Sciences

How to Not Fail an Inspection

White Paper: MasterControl

Overcoming Pharma’s Top 6 Quality and Compliance Oversights Benefits of Platform Integration and Iterative Task Automation For companies doing business in the heavily regulated pharmaceutical industry, quality management and compliance are not just intimidating endeavors — they involve activities that are increasing in complexity as the industry accelerates. Quality successes can only be achieved in the modern regulatory environment when an extensive range of variables are continually monitored and appropriately handled. The prevention of quality oversights — whether they occur during document control activities, corrective action/preventive action (CAPA) management, audit initiatives, supplier relationships, or any other quality-related process — demands precise actions, informed decision-making, and connected processes, all of which can only be realistically achieved in accordance with regulatory requirements by using purpose-built digital solutions.   Avoiding Quality and Compliance Oversights This brief presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time. It also recommends actions organizations can take today to help mitigate the long-and short-term problems caused by each oversight.   Oversight #1: Failure to Adapt to Regulators’ Risk-Based Approach to Quality  Over the past decade, the regulations and standards that affect pharmaceutical companies have been trending toward a greater focus on risk management and risk-based thinking, a shift that has undoubtedly been accelerated by the COVID-19 pandemic. With each update to an existing standard or new regulation that goes into effect, regulatory agencies are placing more emphasis on risk management and mitigation. Regulators across the globe are shifting from what was once a one-size-fits-all regulatory mentality to a more segmented approach that is primarily driven by data. This compliance trend is expected to become more prevalent, as indicated by the U.S. Food and Drug Administration (FDA) Q9 Quality Risk Management guidance which specifies that greater assurance of a company’s ability to deal with potential risks “might affect the extent and level of direct regulatory oversight.”i As the role of good quality data (and auditors’ access to it) becomes increasingly vital to the enforcement of regulatory policies, effective risk management is emerging as the cornerstone of compliance. But risk-based quality management isn’t just important for compliance reasons — it is essential for neutralizing the effects (and potential effects) of quality events that commonly occur in pharma environments.   

Considerations for Modernizing Scientific Compute Research Platforms

White Paper: Avere Systems

Present life sciences research organizations deals with petabytes of data which requires new performance and data management for IT infrastructures and storage solutions. To address the performance and data management issues found in life sciences organizations, a high performance hybrid file system is used which stores data closets to compute resources that can modernize infrastructure and enable discovery. The whitepaper addresses the following questions: What are the considerations for modernizing scientific compute research platforms? What is the impact of infrastructure issues on research and discovery projects? What changes have greatest impact on infrastructure?  What are the characteristics of a modern research environment infrastructure? What is the need for adopting a high performance hybrid file system?

The Value of the State Immunization Registry Program to Improve Vaccination Rates and Quality of Care in Retail Pharmacies

White Paper: Scientific Technologies Corporation

The state immunization registry, or immunization information system (IIS), is an important resource for consolidated patient immunization records so that vaccination providers can access this information.Over the years state immunization registry have evolved into sophisticated data management and clinical decision support tools for vaccination providers. Read this informative whitepaper that brings you the best practices to improve vaccination rates and quality of care in retail pharmacies through state immunization registry.It addresses below questions : What are the biggest barriers to provide immunization services in community practice?  Why the retail-based pharmacist vaccinators have not taken up using the IIS as part of their daily pharmacy vaccination workflow? Did having the registry information provide a positive return on investment in terms of benefits gained? How using the registry impact the vaccination rates for the patients receiving pharmacy immunizations? How to take advantage of an immunization information programs to increase vaccination rates? What steps do private companies take to increase vaccination rates and why? Download this whitepaper to learn how to make immunization registry the best possible way to improve Vaccination Rates and Quality of Care in Retail Pharmacies

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