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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.
Audit Trail Features:
Highlight how Epicor ERP maintains a clear, immutable audit trail of changes to critical documents and processes, a key requirement for FDA audits.
Section 3:
Implementing Epicor ERP for FDA Compliance
Best Practices for ERP Implementation:
Offer insights on how to effectively deploy Epicor ERP in a medical device manufacturing setting to ensure compliance.
Integration with Existing Systems:
Explain how Epicor ERP can be integrated with existing systems to enhance compliance without disrupting current operations.
Section 4:
Case Sharing: Intech Medical
Successful Implementations:
Sharing how Intech Medical have successfully passed FDA audits by leveraging Epicor ERP.