What a DHR Must Contain
1 requires records for each batch or unit showing traceability and the quantity manufactured and approved for distribution. In practice a contract manufacturer's record includes the traveler or work order, material lot numbers and certs, the equipment and tooling used, in-process and final inspection results, labeling or marking data, cleaning or packaging records, nonconformance dispositions, and the release signature. Your customer's quality agreement may add items such as a certificate of conformance or sterilization certificate.
Start by listing exactly what is in your paper DHR today for one product family.
Why Paper DHRs Slow Release
On paper, a quality reviewer opens a folder and checks each page by hand: is every field filled, every initial present, every value inside spec, every cert matching the lot. Missing initials and transcription errors trigger rework loops that delay shipment.
- Fields left blank or filled out of sequence
- Handwritten measurements transcribed incorrectly or illegible
- Cert copies that do not match the lot on the traveler
- Corrections made without proper line-through, initial and date practice
- Records scattered across the floor, inspection lab and quality office
What Electronic Capture Needs to Be Compliant
6 apply: unique user IDs, secure time-stamped audit trails showing who changed what and why, electronic signatures linked to the record, access controls by role, and backup and retention for the life of the device plus the period your customer specifies. Gauges that feed data directly (CMM, torque drivers, vision systems) reduce transcription errors but should be validated as part of the data path. Validation scope should be risk-based: test record creation, edits, signatures, holds and the release workflow thoroughly and document it.
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FDA 21 CFR Part 11 Readiness Assessment
Answer 8 questions on e-signatures, audit trails, access control, and validation status to see how ready your electronic records and systems are for FDA scrutiny.
Review by Exception in Practice
The benefit shows up when the system enforces rules during the work: a step cannot be completed with a missing value, an out-of-spec measurement forces an NCR and holds the lot, and material scanned against the wrong lot is rejected. The reviewer then looks only at exceptions, deviations and signatures instead of every page. Define what the system blocks and what it only flags, and have quality sign off on the rules.
Lots with an open NCR or an overridden step go to full review. Keep a paper contingency procedure for downtime so production does not stop when the system does.
When Paper Is Still the Right Answer
A shop running a handful of low-volume lots a month, with short travelers and a quality manager who reviews them same day, may gain little from an electronic system and take on validation overhead. Some customers also require their own forms. Consider electronic capture when lot release is your bottleneck, when audit findings repeat on record completeness, or when customers request faster genealogy reports.
Roll out one product family first, run paper and electronic in parallel through one full validation cycle, then expand, rather than switching the whole floor at once.
Frequently asked questions
What is a device history record?
It is the record showing the history of a specific lot, batch or unit: what was produced, the dates, quantities manufactured and released, materials and equipment used, acceptance and inspection results, labeling, and approval for release. Under the FDA QMSR it is addressed through ISO 13485 production and traceability requirements.
Is an electronic DHR allowed by the FDA?
Yes. Electronic records and signatures are acceptable if they meet 21 CFR Part 11 and your quality system requirements: audit trails, access control, secure signatures, validation for intended use and retention. Many contract manufacturers run electronic DHRs in an MES, ERP module or eQMS.
How long should DHRs be retained?
Retain them for at least the design and expected life of the device, and not less than the period set by regulation and by your customer's quality agreement, commonly two years after commercial release at minimum and often much longer for implants. Check the quality agreement for each customer and use the longest requirement.
Netray can add private AI review on top of your existing records to flag missing entries and mismatches before the quality reviewer opens the lot, without moving data outside your network.