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Implementing Cloud-Based Pharmaceutical Plant Management Software: Data Security Considerations

ISPE

This involves optimizing workflows, resource allocation, and continuous improvement of processes to achieve desired outcomes. Information security management based on ISO 27001 or similar , which provides a framework for establishing, implementing, maintaining, and continually improving security management systems, procedures, and policies.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources. What Is Digital Health? Market Access and Reimbursement.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources. What Is Digital Health? Market Access and Reimbursement.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

These efforts consume substantial time and resources for both sponsors and health authorities, which may result in redundancies and the need for multiple data integrity checks. Substantial resources are required to develop and implement these advanced SCDM solutions, which has been a barrier to becoming the industry standard.

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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

The FDA Law Blog

In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge the rapidly moving waters between traditional regulatory concerns about safety and effectiveness on one side and cybersecurity, data privacy, and identity integrity on the other.

FDA 59
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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

1 This view prioritizes steps that reduce the use of natural resources and the release of undesirable products such as carbon to the atmosphere or plastics to landfills. 17 Improving production planning and resource management optimizes facility and service utilization and overall energy consumption. 7 An integrative (vs.