Mastering eDHR Document Management: Best Practices for Retention and Archiving Policies

Category : eDHR document management | Sub Category : eDHR document management retention and archiving policies Posted on 2023-07-07 21:24:53

Mastering eDHR Document Management: Best Practices for Retention and Archiving Policies
Introduction:
The adoption of electronic Device History Record systems has changed how manufacturers manage their production records.. Retention and archive policies are needed with the shift from paper to electronic records.. Key considerations and best practices for eDHR document management retention and archive policies will be covered in this post.
Retention and archive policies matter.
Retention and archive policies are important for managing eDHR documents.. The policies set guidelines for how long records should be kept and how they should be secured.. By implementing effective retention and archive policies, manufacturers can ensure compliance with regulations, facilitate audits, maintain a comprehensive trace of product history, and mitigate risks associated with document loss or tampering.
There are some key considerations for eDHR document and archive retention policies.
1. Understanding the specific regulatory requirements for your industry is the first step in determining an effective retention and archive policy.. FDA, ISO, or other governing bodies may have requirements that are considered considerations.. By aligning your policies with the regulations, you can avoid penalties, maintain product quality, and ensure safety for end- users.
2. Clear retention periods are important to ensure that eDHR documents are retained for an appropriate duration.. The document type and purpose can affect the retention periods.. It is important to consider factors such as the product lifecycle, warranty obligations, post-market surveillance requirements, and any legal or contractual obligations.
3. It is helpful to categorize documents based on their type and criticality.. For example, documents such as product specifications, manufacturing instructions, and quality control records may require longer retention periods, while non-essential records, such as routine email communications, may have shorter retention periods.. You can allocate storage resources and strategies by categorizing documents.
4. Ensure that eDHR documents are stored securely in a centralized electronic repository.. Require robust access controls, user permission, and encryption measures to prevent unauthorized access.. Enhancing the efficiency of document retrieval processes, including Metadata Tag and Search, is one way to do this.
5. Disaster recovery plans and regular backups are important for eDHR documents.. By backing up your electronic records, you can reduce the risk of data loss due to hardware failures, cyber- attacks, or other unforeseen events.. Disaster recovery procedures should be tested regularly to make sure they can restore documents in a timely manner.
6. The retention policy requires periodic reviews of retained eDHR documents to determine if any can be discarded.. Ensure compliance with data privacy regulations and protect sensitive information by securely disposing of documents that have reached their retention period.. If required, provide an audit trail if the disposal process is documented.
Conclusion
Developing robust eDHR document management retention and archive policies is important for manufacturers.. By adhering to industry regulations, manufacturers can ensure compliance, facilitate audits, and reduce risks associated with data loss.. The right policies can help manufacturers to make their eDHR systems more efficient.