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ERP Validation for Medical Device Manufacturers
Enterprise software vendors eagerly focus on eliminating defects from their software. Because there is a real cost attached to software defects for both vendors and users, following software validation principles for medical device manufacturers is both compelling and essential.
The United States government through its Food and Drug Administration (FDA) arm has issued definitive guidelines medical devices that are computer software controlled, Manufacturers wishing to supply the very large US market with such devices must follow these guidelines. In particular, the government’s concern is a growing class of mechanical devices with embedded software that runs to hundreds of thousands of lines of code.
The FDA is the primary body that is responsible for the approval to use therapeutic goods in the general US population. The FDA has developed well-understood protocols for the testing of chemical agents and there is a significant scientific understanding of the procedures and tests that are performed prior to the granting of approval for new medicines.
There is a fast-growing trend to enhance medical treatment options, not by the invention of new drugs but by the manufacture of medical devices that deliver already approved medications in a closely controlled manner that relies on bio-feedback mechanisms and other therapeutic regimens.
A very significant portion of these new medical devices are completely reliant on inbuilt sophisticated software to control the mechanical, electrical and electronic components. Therefore for companies that are designing and manufacturing medical devices, it is essential to include a formal testing regime which automates the detection of software defects. For the FDA, its expertise in evaluation of therapeutic chemicals does not translate readily to the approval of devices controlled by computer software.
To address this shortfall in regulatory expertise and control, the FDA commissioned the document General Principles of Software Validation; Final Guidance for Industry and FDA Staff. This document outlines the required level of rigor in software testing that manufacturers must meet to gain FDA approval.
The malfunctioning of a device due to preventable software failure is potentially catastrophic. However, because the potential of these devices to perform life-sustaining functionality is so compelling socially and financially, companies are willing to subsume the risk. However, developing and manufacturing this new class of life-saving devices is not done in a way that carries cavalier risk and so the FDA document is now critical for all medical device manufacturers.
Highlights of what the FDA requires from manufacturers
Section 3.1.2 Verification and Validation
This section specifies methods to find defects in specification documents, ways of estimating the number remaining defects and other methodology that will build an acceptable level of confidence in the product prior to shipping.
Section 4.2 Defect Prevention
To achieve that aim, the manufacturer must focus on software quality assurance initiatives. These are designed to stop the introduction of defects during the software development phase. The often-used but exceedingly poor methodology of trying to introduce quality into the code after it is written is completely unacceptable. Software development methods such as SCRUM would also not be acceptable because speed of development is not the guiding imperative. Significant software testing methods are essential even though that on its own is not enough to assume that passing tests makes the software suite fit for purpose. Independent software testers are key to building confidence particularly where such testers are expert in destroying software assumptions.
Section 4.7 Software Validation after change
This section promotes the use of a complete software testing suite as essential. After any changes to software, no assumption is made that the impact of the changes are restricted to the modules where changes took place. Each iteration of the testing regime tests every part of the software. While this is time consuming, the outcome is confidence in the fact that there will be no catastrophic failure.
Section 5.2.4 Construction or Coding
Coding itself must meet the strictest of guidelines regarding complexity, style and the insertion of significant explanatory comments. Programmers need to have coding output constantly monitored. The role of Quality Analysts and Test Managers is crucial. Procedures that encourage programmers to submit smaller output code volumes frequently will assist in producing better code.
5.2.5 Testing by Developer
While the developer has an initial role in determining whether code that is written actually works as required, it is not the role of the developer to make a final determination. That specific role is the province of the Testing Team. One specific defect that needs to be tested for is the identification of dead code that is never executed. While on the surface it appears that such dead code will have no effect on the working code, in fact it exposes a potential exploit for malicious software and must be eliminated. Today, the identification of “dead” code is built into all enterprise compilers.
Because software validation requires a combination of procedural, administrative, and technical controls, no software package can claim to be “validated” or compliant” out of the box. However, The Copley Consulting Group has developed an Infor CloudSuite Industrial (SyteLine) validation support kit in conjunction with cGMP Validation, an expert partner in validation — includes the scripts and best practice templates to get you started on your validation process as well as project kick start services to deliver a thorough, easy and quick approach to validation.
Contact a Copley Consultant today to find out more about our Validation Kits for Medical Device Manufacturers.