The burden of paper-based documentation in Medtech:

The FDA’s e-CFR, title 21, subchapter H-Part 820 outlines the Quality System Regulations for medical devices – manufacturers must design, develop, produce and service their products in accordance with these regulations if they wish to operate in the U.S. market. Similar regulations exist in other countries of the world and use the ISO:13485 QMS guidelines and FDA regulations as a frame of reference to define their own requirements. These regulations are put in place to ensure patient safety and require manufacturers to have extensive records and documentation to demonstrate they are compliant with relevant regulations.

Medtech manufacturers are bogged down with significant regulatory burdens including manufacturing regulation requirements, work instructions, and device history records (DHR) for all stages of production. Each manufacturer must have DHF, DMR, and DHR in place for each product variant manufactured.

A DHF is a design history file/record and contains at a minimum- user requirement, design and development data, change request data, design input/output data, validation, verification and CAPA data. All of this data must be stored for each product variant, and should have requisite time stamps, signatures of responsible personnel and clear records of approval.

A DMR or device master record is the essential instruction manual that contains all details of how the device is to be assembled in accordance with applicable regulations. This document should cover each variant of every product manufactured. It should contain, design specs, BOM data, production process, equipment specs, packaging and labelling specs, QA process, acceptance criteria, and maintenance/servicing procedures.

In manufacturing, a DHR or device history record, is used to verify that the DMR has been followed to produce the specific device/s. The DHR contains the production steps executed, product-component identifications, acceptance records with operator qualifications and material records. When extensive documentation is handled with paper-based systems, it becomes extremely complex. With medical devices becoming more sophisticated and with more variants, the effort required to create and maintain DHFs, DMRs, and DHRs on paper increases exponentially. This level of record-keeping and documentation is subject to human errors, is expensive, and time-consuming with the amount of movement and paper involved. Another major issue with paper-based documentation is security and storage. Unless preserved properly, paper-based records are prone to decay and damage, and preserving them is costly for storage and maintenance.

Benefits of digitising document management

The biggest benefits of digitising documentation in medtech is the reduced costs associated with paper, its storage and the fewer man-hours to create, maintain and audit the paper-based documents. It is estimated that an American office worker uses an average of 10,000 sheets of paper every year, this data may be significantly higher for medtech operations. Professionals working in a paper-based workflow spend up to 35-50% of their time searching for information with no centralized repository or index.

Digitising also means accessibility. Records and documents stored on a local server or the cloud can be accessed immediately rather than having to be searched for in file cabinets. This improves the ability to prove conformance to regulations, increasing the speed of compliance and the speed to market. 

As design data  on assembly and production is digitised, it is available for analysis, and improvement. This means lower production costs and better production efficiency as data is readily viewed and analysed. Digital data also enables faster containment and CAPA action, for internal and external issues.  Digital DMS or document management system can benefit medtech manufacturers, but only when digital documentation and record keeping does not add workloads and helps them focus on their primary responsibilities.

Digitisation makes operations more efficient, reduce errors and frees up time. Going paperless is the way forward and the MES you choose may prove to be a game-changer.

The MES and e-DHRs

MES is an important application for the highly regulated industry, which, is viewed as a separate manufacturing practice by Gartner when it classifies operations and helps leaders determine which MES to choose from. The ideal MES for medtech should help manufacturers obtain full benefits of Industry 4.0, automation and AI-led learning in their operation. Regulatory bodies around the world and QMS standards are moving toward a risk-based approach to quality management and making a leap towards quality assurance from end-of-the-line quality control practices.

MES helps manufacturers adapt to new requirements and help digitalise operations. The first step is to have a digital document management system, within the application. The creation of DHFs, DMRs and DHRs is possible through the MES electronically and preferably in the most automated manner possible. Automation in document creation implies two things:

  1. Data which can be collected as a result of entry by personnel or process data through IoT should be documented automatically in the correct layout and format
  2. All data collected must be compliant with regulatory requirements and best-practices in terms of time-stamps, e-signatures and qualification/validation specifications

The MES platform provides a link for traceability and verification between the DHF, DMR and DHR and when this is digitized it is error free and automatically verified. It helps manufacturers manage documentation for a large amount of product variants with minimal effort. Every change request, design spec, sub-assembly, and shop-floor transaction is recorded and reported by the application. This can be a game-changer for manufacturers, as, they can now afford to have a larger number of product variants, and add more complex electronic parts and sensors without errors in the process. The right MES partner can ensure that the application provides 100% compliance and covers 100% transactions, specifications, and validations in terms of data capture and reporting.

Automating DHR with a modern MES creates an eDHR system that is faster and more flexible than the paper-based method by providing real-time conformance more efficiently and without human errors. e-DHRs have the potential of freeing up considerable operator time and can fully or partially automate data collection in manufacturing depending on the inherent level of automation. It can fully eliminate errors and help operators create records, which are as easy as clicking pictures of measuring devices or production panels, from their mobile devices. AR becomes a reality with a good MES and with AR the ability of operators to capture and report data in real-time improves.

The ability of the MES vendor to create e-DHRs and other electronic documents and records such that they are fully compliant and intuitive determines which solution works best for a given operation. Leaders must choose their partners carefully and ensure that the application being chosen reduces the workload and completely eliminates paper-based systems.