Are You Gambling With Medical Device Compliance?

The FDA requires CMOs to maintain a DHR both as proof that each finished device was made according to a validated process and for traceability in the case of a defect. Most CMOs use manual, paper-based processes to document production and store the records.

• lot/batch number
• source information for raw materials or subcomponents used
• a reference to each procedure used
• a reference to each inspection and test procedure used
• identification of machines used for the batch along with a reference to the calibration records for each machine
• the names of individuals performing each process step and the dates the steps were performed
• a reference to the training records of each individual performing process steps
• the quantity manufactured (pass/fail)
• the quantity released to distribution
• the name of the individual responsible for releasing the lot/batch for distribution
• a sample of the product/package labeling used.

In a paper based system, each step in the production process, causes an employee to create paper records. The amount of documentation required for a typical batch can fill a file with 2 to 10 inches of paper². Each step in the process and each point of documentation are prone to error and are thus potential areas of failure in creating the DHR.

The challenges of a paper system come from relying on employees to document thousands of records by hand.

The power of a fully integrated system comes from connecting the data, in real time, from the manufacturing systems that house data needed for the DHR. Not only does this achieve traditional compliance for the DHR, but it enables the following benefits:

• Complete DHR is available in one view from one system. There is no need to cross-reference records from multiple systems.
• Enforced regulatory compliance. Unlike the paper system, a fully integrated system ensures manufacturing processes are performed in the required order, steps are not missed, and documentation occurs. The DHR is complete because real-time checkpoints do not allow missed steps or missed records.
• Elimination of manual processes. Documentation needed for the DHR is collected passively by the system as the steps of the process occur. Handwritten records and the errors associated with them — inaccuracy, missing data, illegibility, misfiling — are eliminated. Separately, production time spent documenting is eliminated, improving productivity. 
• Automated error prevention. The connectivity of systems in real time enables programmable error prevention. For example, the connectivity with the training system only allows employees who meet training requirements to log in to perform a manufacturing step. Likewise, connectivity with the equipment system ensures a machine has been calibrated before a step can be performed. Steps cannot be skipped or partially done and must be performed in sequential order as programmed. Barcoded and electronically scanned parts further reduce errors.
• Reduced audit time. A typical audit using paper-based records takes two to three days. Much of this time is spent with two to three employees running to find the right files. Once the files are found, additional data must be cross-referenced from the disconnected systems. With a fully integrated system, the audit takes about half a day. The time savings benefits OEM auditors, regulatory auditors, and the CMO.
• Remote audit capability. Customers have the option to perform a scheduled or surprise audit remotely using a shared screen to review random batches for DHR compliance.
• Elimination of paper trail, storage, and retrieval costs.The hassle of a paper system is removed, including filing and retrieval time. Offsite storage is no longer needed. Onsite storage is now available for another use.
• Real time data availability. With real time data, information is easily obtained to make informed, timely, and effective decisions.

If errors are not caught before filing, this becomes a problem in the case of a defect or recall. If the record is wrong, you are not only out of compliance, but you cannot identify and fix the root cause of a problem. In the case of audits, paper files are notoriously time-consuming to retrieve and have higher rates of non-compliance due to the reasons listed above.

Documenting device history seems like a process ripe for automation. Yet, most CMOs are deterred from creating a fully automated system because the records needed for the DHR contain fragmented data stored in several disconnected systems. Most manufacturing environments use 5 to 10 different systems (e.g., training, equipment, machine performance, subcomponents, employee performance, ERP). It is not possible to simply create an electronic DHR for each batch by cross-referencing the data without integrating the systems. DHR integration into one record requires compatibility across multiple systems. Connecting these systems is not easy, and requires financial investment and time. Some partial solutions exist in the industry. For example, handwritten records can be converted to electronic records by data entry. But data entry introduces potential for errors, and does not solve the problem of disconnected systems. Some software applications can create a partially electronic system. But, these software systems cannot integrate with the CMO’s existing systems.