Document Control Checklist
Certainly, here's a Document Control Checklist tailored for the life science industries, which includes pharmaceuticals, biotechnology, medical devices, and healthcare: Document Identification: - Assign a unique…
Computer Software Assurance | Compliance Group Inc
Computer Software Assurance in life sciences refers to the processes, practices, and techniques employed to ensure the reliability, quality, and safety of software applications used within the field of life sciences. Life…
Requirements and Audit Considerations for 21 CFR Part 312 – Investigational New Drug Applications
21 CFR Part 312 outlines the regulatory requirements governing Investigational New Drug (IND) Applications in the United States. Compliance with these requirements is essential to ensure the safety of human subjects…
Leveraging Paperless Validation for Regulatory Compliance in the Life Sciences Industry
In the rapidly evolving landscape of the life sciences industry, maintaining rigorous regulatory compliance is paramount. Traditional paper-based validation processes have long been the standard for ensuring product quality,…