Validation, Commissioning & Design Featured Articles

  1. Why The Regional Site Manager Is The Swiss Army Knife Of Clinical Trial Monitoring 1/28/2025

    The Regional Site Manager (RSM) monitoring model eliminates numerous clinical trial risks by leveraging efficient, start-to-finish site management by a single, expert point of contact.

  2. Addressing Blind Spots In Assuring Therapeutic Equivalence 1/14/2025

    The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.

  3. Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences 1/13/2025

    Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

  4. Deploy AI To Become A cGMP 'Special Agent' With A License To Care 1/7/2025

    Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."

  5. Building A Connected Quality And Manufacturing Ecosystem In Life Sciences 12/27/2024

    Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

  6. Optimizing CAPA For FDA Recall Success: A Roadmap For Life Sciences Quality Professionals 12/27/2024

    Discover why an optimized CAPA process is crucial for life sciences companies to enhance quality, ensure regulatory compliance, prevent product recalls, and maintain market competitiveness.

  7. 4 Things To Consider In Pharmaceutical Labeling 12/11/2024

    Pharmaceutical labeling demands precision. Examine key considerations for ensuring accuracy and efficiency in your process, from robust control systems to diverse printing options.

  8. Effective Procurement Strategies For Labeling Systems In Drug Manufacturing 12/11/2024

    What is actually behind the procurement of a pharmaceutical labeling machine and how does the process work? You can find out here what the path to your pharmaceutical labeling machine looks like.

  9. Count On Data Integrity Auditors Making These 10 Requests 12/9/2024

    Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.

  10. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.