Can I store Device History Records in Grand Avenue?

Device History Records (DHRs) or batch records are compilations of records containing the production history of a finished device or pharmaceutical. For example, a DHR or batch record may contain documentation such as receiving inspection forms, certificates of conformance, purchase orders, manufacturing travelers, and sterilization records.

Although Grand Avenue Software (GAS) was not designed for this purpose, some customers are managing their Device History Records (DHRs) in GAS as controlled documents. Typically, they scan entire DHRs into PDF files, assign them unique document numbers (which could be the lot/serial number), and upload the PDF files into GAS as controlled documents using either the Document Change Request (DCR) or batch import features.

Advantages and Disadvantages

Once completed DHRs are stored in the Document Control module, no quality system processes are needed to manage them. Unlike typical controlled documents, DHRs are not subject to revision or periodic document review, nor do they require an audit trail. Also, DHRs are often made up of scanned copies of paper documents, so they cannot be indexed for full-text searching. GAS serves as a secure, backed-up repository for these records, but along with that comes a cost.

Each file uploaded to Grand Avenue is stored as a binary image in the database. Therefore, the primary file and additional files associated with each controlled document consume database storage, and high volumes of large DHRs will consume database storage very quickly. The database size has no impact on GAS performance, but, as a database grows, the total cost of storage and the amount of time required to perform maintenance processes such as backups increases proportionately.

Customers with hosted GAS installations are subject to additional fees once their databases exceed their originally allotted size of 20 GB.

Conclusion

We advise companies that have well-developed IT infrastructures and produce high volume commercial products to store DHRs electronically on shared file servers rather than in GAS. For small companies with limited IT infrastructure and/or lower-volume products, storing DHRs as controlled documents is a viable option as long as database growth is monitored. You can also refer to the article https://grandavenue.atlassian.net/wiki/spaces/CS/pages/542736392 for additional information.