Glossary Term
Good Documentation Practice
Definition
Good Documentation Practice (GDP) refers to a set of standards and guidelines ensuring that documentation related to the design, manufacturing, testing, and distribution of medical devices is complete, accurate, legible, traceable, and compliant with regulatory requirements. GDP applies to both paper-based and electronic records.
Relevance to the MedTech Industry
GDP ensures the integrity, consistency, and reliability of documentation used in medical device development and manufacturing. Proper documentation is critical for meeting regulatory requirements, demonstrating compliance, and facilitating audits or inspections by agencies like the FDA or EU regulators.
Additional Information & Related Terms
Key Principles of GDP
Attributable: Clearly identify who performed, reviewed, or approved an action or entry.
Legible: Ensure all entries are clear, readable, and permanent.
Contemporaneous: Record data in real-time as tasks are performed.
Original: Use primary records or verified copies as the source of truth.
Accurate: Ensure data and entries are free from errors or misrepresentation.