The Log Form: Monitoring of New Regulations provides a standardized and inspection-ready template for documenting the continuous review of updated regulatory requirements across international authorities such as EMA, FDA, ICH, and EU Eudralex.
 
This log form is designed for biotech and life science companies to ensure ongoing GxP compliance through active monitoring of new or revised legislation, guidelines, and pharmacopoeia updates.

It serves as a traceable record of regulatory intelligence, documenting each review period, impact assessment, and resulting Change Control (CC) actions.
 
The form is professionally written and pre-filled (≈ 99 % complete), requiring only company name, QA signature, and review dates.
It aligns with ICH and GMP principles for maintaining a compliant and up-to-date Quality Management System (QMS).
 
Includes:
Structured fields for recording review periods (year and quarter)
Documentation of changes and regulatory relevance
Links to official sources (EMA, FDA, ICH, Eudralex, Pharmacopeia)
Section for Change Control initiation and QA approval
Notes and signature fields for verification and oversight
 
Using this form ensures that your organization can demonstrate proactive compliance monitoring — a key requirement during audits and inspections.
It provides documented proof that all regulatory updates have been evaluated and acted upon as needed.