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Industry Solutions / Medical Device / Download Documents
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Table of Contents
Section 1:
Understanding FDA Regulatory Requirements
Detailed Explanation of Relevant FDA Regulations:
Discuss specifics like Quality System Regulation (QSR), risk management,
and record keeping requirements.
Common Compliance Challenges:
Identify typical areas where medical device manufacturers struggle in terms
of FDA compliance (e.g., documentation, quality assurance processes).
Section 2:
Role of Epicor ERP in Addressing Compliance Challenges
Automated Documentation:
Explain how Epicor ERP automates the creation, storage, and retrieval of compliance-related documents.
Traceability and Quality Control:
Describe Epicor’s capabilities in maintaining detailed records of product development and batch production, crucial for traceability and managing recalls.
Risk Management Tools:
Discuss how Epicor ERP integrates risk assessment into product lifecycle management, helping companies comply with FDA’s expectations for risk management documentation.