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Glossary Term
Electronic Records Compliance
Definition
Electronic Records Compliance refers to the adherence to regulatory requirements for the creation, storage, management, and use of electronic records in medical device manufacturing, clinical trials, and healthcare. Compliance ensures data integrity, security, and traceability, with key frameworks such as FDA 21 CFR Part 11 and EU GDPR governing electronic records in the MedTech industry.
Relevance to the MedTech Industry
Electronic Records Compliance ensures the reliability and security of digital data, which is critical for regulatory submissions, audits, and quality assurance. It helps manufacturers and healthcare providers maintain trust and accountability by safeguarding data integrity and patient privacy.
Additional Information & Related Terms
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