by John Lafferty
Read time: 3 minutes
The FDA has just issued its long-awaited draft guidance on Software Validation. The new draft guidance entitled Computer Software Assurance for Production and Quality System Software (dated 13th September 2022) represents a new dawn for software validation in a manufacturing environment.
New: Un-scripted Testing May be an Option for Certain off-the-shelf Software
The new guidance is risk-based, as one would expect, but for the first time, it guides that un-scripted testing may be an option for assurance of certain commercial off-the-shelf software (COTS) including certain uses of spreadsheets. This news will come as music to the ears of many Pharmaceutical and Medical Device manufacturers around the world who have long questioned the added value of some of the documentation required for testing COTS systems up to now.
Of course, the draft guidance does not contain a carte blanche for manufacturers to use software with minimal testing, the FDA reiterates that ‘software testing alone is often insufficient to establish confidence that the software is fit for its intended use’ and that the focus should be on ‘on preventing the introduction of defects into the software development process’ and the ‘use of a risk-based approach for establishing confidence that software is fit for its intended use’.
Establish Risk Associated with the Intended Use of the Software and Use Commensurate QA Methods
The focus of the new draft guidance is very much on establishing the risk associated with the intended use of the software and implementing quality assurance methods that are commensurate with that intended use.
Distinction between Software that is Part of the Production/Quality System and Software that Supports the Production/Quality System
A distinction is drawn for the first time between software that it used directly as part of production or the quality system (which is considered a higher risk) and software that supports production or the quality system (which is considered a lower risk).
Software that is considered to be used directly is defined in the guidance as;
‘Software intended for automating production processes, inspection, testing, or the collection and processing of production data; and
Software intended for automating quality system processes, collection and processing of quality system data, or maintaining a quality record established under the Quality System regulation’.
Software that is considered to be used as a support is defined as;
‘Software intended for use as development tools that test or monitor software systems or that automate testing activities for the software used as part of production or the quality system, such as those used for developing and running scripts; and
Software intended for automating general record-keeping that is not part of the quality record’.
Both must be validated but the risk-based approach will lead to a much less burdensome task for the supporting software. The guidance promotes leveraging of software supplier testing and the use of automated testing tools as a means of reducing validation effort whilst continuing to assure software quality and avoid risk.
The new draft guidance does not apply to Software as a Medical Device
It must be noted that the new draft guidance does not apply to Software as a Medical Device (SaMD) and that when it becomes Final Guidance, it will replace only Section 6 (‘Validation of Automated Process Equipment and Quality System Software’) of the FDA’s existing guidance – General Principles of Software Validation.
This new draft guidance will require careful reading to fully digest its implications and the FDA has invited comments under docket number FDA-2022-D-0795 by November 14, 2022. At SQT Training Ltd. we will be exploring the implications of the new draft guidance as part of our Software Validation Training course and embedding the final guidance in the core of course materials.
At SQT Training we run comprehensive training courses on Software Validation and other Life Sciences subjects.
Course Title: Software Validation
Course Content: The main objectives of this course are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Software Validation and Computer Systems Validation.
Course Date and Booking: See the Dates and Book the Course here.
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About the Author
John Lafferty is Managing Director of Northridge Quality & Validation Ltd and Life Sciences Tutor at SQT Training.
Specialties: His specialties include Software Validation, MDSAP, ISO 13485, ISO 14971, and MDR. John is the holder of a Degree in Manufacturing Technology, Certificate in Training & Continuing Education, Certificate in Quality Management.
Experience: He has over 25 years of experience in the medical device and pharmaceutical industry. He was a Senior Manager of a multinational Medical Devices plant where he managed the Quality, Regulatory, Environmental, and Health & Safety Management Systems. He has successfully completed numerous consultancy projects with medical device manufacturers in Ireland and throughout Europe.