article thumbnail

Understanding WHO Guidelines for Batch Manufacturing Records

Dot Compliance

By following these guidelines, manufacturers can: Protect public health: Ensure that the products they produce are safe and effective for use. By understanding and implementing these guidelines, manufacturers can play a vital role in protecting public health and maintaining the integrity of the pharmaceutical industry.

article thumbnail

Proactive Transformation: Why Healthcare Organizations Need to Digitize Before (Not During) the Next Crisis

Healthcare IT Today

Digitizing patient care records empowered MCHD to move from multiple systems to a centralized repository, leading to more efficient records management with proper retention schedules and regulatory compliance. Though the agency serves more than a half million people, our process automation department is a two-person team.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 52
article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 40
article thumbnail

SQA Regulatory Surveillance Summary for January and February 2024

SQA

A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety. In addition, SOPs did not align with specified requirements and did not have a standardized format.

FDA 40