Going Electronic Without Losing Control: eDHR Done Right

Going electronic in a regulatory world – do I take the plunge? It’s a common dilemma that manufacturers who must comply with stringent medical regulations (such as FDA 21 CFR Part 820 and 21 CFR Part 11 in the US, EU MDR 2017/745, ISO 13485, and associated GxP requirements) will always have. I want to get rid of paper, but is it worth the risk and the effort, and how do I reduce the risk? How do I persuade my quality department that this is a risk worth taking?

Ok, so the first question – why should I do this? What is wrong with the reassuringly thick stack of paper I can take out of storage and hand to an auditor when they ask or when I must investigate an issue?

What is the issue with paper DHR?

Invariably, customers asking the question “What is the issue with paper DHR? It’s how we’ve always done things” are already struggling with paper DHR.

It is not uncommon for a DHR for a medical device to be tens, if not hundreds, of pages long – it might contain diagnostic data printouts/label print copies/test device receipts, concessions documents, non-conformance details, and many other pieces of information. Ensuring that this is complete and accurate is challenging for several reasons:

Up versioning of standards and work instructions is risky when there are multiple paper copies around the shopfloor, taped to workstations or pin boards
Critical paper documents can get damaged or lost along the route around the shopfloor – they could get separated from the item or batch being manufactured
Critical information may be missed along the way that is only discovered late on in QC
It is difficult to ensure that appropriately skilled operators are carrying out / signing for critical checks
Writing on documents could be illegible, characters can get mixed up (e.g., 5 vs S), and initials can be difficult to trace back to the operator who signed
Corrections could be documented incorrectly, leading to audit findings
Where partial batches have issues, it is costly and difficult to split the batch for rework, as it is too costly to duplicate paperwork.
Often, issues with paperwork are not discovered until right at the end of the process, during a laborious and costly check of every page of the document pack. Where problems are found, this often leads to costly rework to fix.

It is costly to store paperwork

Paper DHR needs to be stored for the lifetime of the device, and it can be difficult and time-consuming to retrieve it. Manufacturers often pay $5–15 per archive box per month for off-site storage. Over a product’s lifetime, this can total hundreds of thousands – or even millions – of dollars to store paper records in specialised storage facilities. Quick, reliable, and accurate retrieval of key information is critical when auditors visit or there is an incident. Paper storage simply cannot provide this efficiently.

So why should I trust an electronic system?

The eDHR (Electronic Device History Record) is a legal record of manufacture. It must contain evidence that the item has been manufactured in compliance with the DMR (Device Master Record) and must have regulatory compliant e-signature where required.

This doesn’t have to be a leap of faith – the productivity opportunity and the increase in quality output are obvious, but all stakeholders, especially the quality team, will need to know that this is not a castle built on sand before they agree to transition to electronic records. They also need to know that this change doesn’t come with a costly and lengthy project to implement.

So, what are the foundations that give you the right to claim that you are eDHR capable?

Control of the definition of the manufacturing process – in-depth controls of all quality critical aspects of manufacturing – not just of routing and BOM, but a controlled combination of routing and BOM, with all associated information, such as skills, tools, choice of machines, etc., must also be proven and solid, and permission-controlled. Extending this to extension routings, such as triage investigation and rework, ensures that the whole manufacturing history of an item is retained in one place.
Validation stages and change control – a system must support a customer’s extensive change management of process change and new product introduction. Having a system that enables and controls validation stages (virtual test, prototyping, preproduction, production, and obsolescence) within one environment (i.e., not copying complex flows from test sites to production sites) is very powerful in reducing risk and effort, and ensures that products are made appropriately, not just based on their design, but on their validation status is key
Immutable Storage of eDHR data – a lot of systems will claim that they have an irrefutable, immutable record. Is this technically correct, or could a database administrator inadvertently change or delete critical records by the back door? The right Manufacturing Execution System (MES) stores designated regulatory data using technology such as blockchain that guarantees immutability.
To drive continuous improvement, it is necessary to capture far more data than is required for regulatory record-keeping. The manufacture of an item can generate thousands of data records that capture every button press or change in conditions or state throughout the process. A configurable MES supports the collection of any data that will be useful in driving improvement and allows you to define exactly which subset of data is critical to quality and to the regulatory manufacturing record.
E-signature – data in an MES is traceable – a record of exactly who did what and when is a basic output of MES. Meeting electronic signature requirements ensures regulatory compliance and is a cornerstone to moving from paper DHR to eDHR.

How do I transition?

Another aspect of this transition is the effort and investment to get started. Eyelit Technologies offers a cloud-based SaaS solution that has a high degree of configurability, leaving control in the hands of the customer, not consultants. Services work focuses on enabling the customer to own and manage their own system for the long term, not build it for them, then charge for future changes.

The implementation can be brought in in stages, building the solution on the shopfloor, allowing operators to gain confidence and get used to the system whilst getting immediate productivity benefits – data flowing from day 1 – then build into eDHR from there, or it can be brought in in one go. The Eyelit MES has a built-in test plan manager that the customer can use to record detailed testing in situ – avoiding the risk of Excel test plans getting lost as project teams move on.

Modern MES solutions have a validation pack that helps guide the customer through detailed and intensive software testing, meaning that they are not building validation test plans from the ground up on software they are not yet fully familiar with – they can choose to follow this and add specific use cases for their environment on top and additional tests as they see fit to cover their needs.

All of these capabilities – configurable process control, immutable eDHR storage, e-signatures, and stepwise implementation – together illustrate why a modern MES like Eyelit is the natural enabler for moving from paper-based DHR to a fully electronic, compliant, and efficient process.

All of this is designed to make the implementation and validation process as risk- and pain-free as possible for the manufacturer.