Software Validation - Clinical Trials

E

esalsan

#1
Dear covers,

I am having difficulties in identifying regulatory requirements for validating software that is used in clinical trials.

As a CRO we analyse medical images and calculate some biological parameters using software applications (some internally developed, some from third parties). Pharmaceutical companies typically use our results together with many others during a clinical trial to determine the effectiveness of a drug.

Regarding explicitly to software validation, I believe that 21 CFR 820.70(i) applies to us. Any other regulation (US or EU) we should be aware of?

Are there any Guidance documents for interpretation of the requirements? (e.g. does GAMP 5 applies to us?)

We are trying to draw a line on how deep, which tools and which changes would require which treatment regarding validation, based on the actual requirements and official guidance documents (combined with risk management practices).

Note: I am pretty familiar with the medical device regulations, including the FDA Guidance on the Essential Principles on Software Validation (which technically does not apply to us, although we are using it as a proxy for the moment).

Thank you!
 
Last edited by a moderator:
Elsmar Forum Sponsor

JJ_FDA

Involved In Discussions
#2
I think Essential Principles is a good proxy, but also look into 21 CFR Part 11 for additional requirements for studies your sponsor intends to submit to FDA. There is an accompanying guidance document. I would post a link, but I'm not allowed to yet (post count not high enough). It is easily Google-able.

In combination with the applicable predicate rule (I guess in your case ICH GCP) they tell you what you need to validate for the Agency to consider electronic data and electronic signatures to be trustworthy and equivalent to paper records. They do not tell you how you need to validate; you are free to use GAMP 5 or another approach.

Speaking of Essential Principles, the EU has a similar document, Annex 11, which is GMP-specific. I don't know if there is a GCP-specific document.
 
E

esalsan

#3
Thank you JJ_FDA for your quick response.

Funnily enough part 11 does not apply to us because we provide paper records with handwritten signatures (pharma customers are happy with this).

So far the list of references goes as follows (intended to be updated):
Regarding computerised systems:
* Annex 11
Part of Volume 4 of GMP (rules governing medicinal products in the EU)
* ICH Topic Q 7 GMP for API - section 5.4
* 21 CFR 820 - section .70(i)
Part of ICH Quality Guidelines

Regarding electronic signatures:
* 21 CFR 11
* associated FDA Guidance
 

JJ_FDA

Involved In Discussions
#4
Are you absolutely sure that Part 11 doesn't apply to you for electronic records?

For example, even if you use paper records, your system may be considered in the scope of Part 11 based on whether they consider you to rely on the electronic record rather than the paper version to do regulated things. This may also be the case if there is information necessary to enable the reconstruction of your study that is in the electronic record but not reproduced in your paper record.

In the first case, consider where there is some data transformation going on (spreadsheet, instrument). I have no idea whether anything in a clinical setting would do this.

In the second case, consider audit trails. Is all of the data captured by the software's audit trail also reproduced in the printouts?

I have found RAMP (Risk Assessment and Management Process): An Approach to Risk-Based Computer System Validation and Part 11 Compliance by Siconolfi and Bishop useful.
 
Thread starter Similar threads Forum Replies Date
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 0
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 10
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
C Software validation - Off The Shelf Software - Web hosted ISO 13485:2016 - Medical Device Quality Management Systems 6
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
S Validation of COTS Equipment plus Software Qualification and Validation (including 21 CFR Part 11) 12
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
Pmarszal Software Validation Training Course - Recommendations Training - Internal, External, Online and Distance Learning 3
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
R FDA Requirements - Printing Equipment Software Validation Qualification and Validation (including 21 CFR Part 11) 1
G Windows 10 OS build Software Validation US Food and Drug Administration (FDA) 1
S Where to keep Enterprise Resource Planning software (ERP) Validation Records ISO 13485:2016 - Medical Device Quality Management Systems 1
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
M Software Validation Guidance Suggestions Various Other Specifications, Standards, and related Requirements 6
S QMS software validation - Documentation ISO 13485:2016 - Medical Device Quality Management Systems 5
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
R Software validation - off the shelf X-Ray Software Quality Assurance 3
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Software validation of Data Exporter ISO 13485:2016 - Medical Device Quality Management Systems 3
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
P Software Validation for Equipment - Question ISO 13485:2016 - Medical Device Quality Management Systems 5
D Medical Device Software Tool Validation - Compilers! IEC 62304 - Medical Device Software Life Cycle Processes 7
N When is Medical Device Software Validation required? ISO 13485:2016 - Medical Device Quality Management Systems 6
O Process Mapping prior to Validation and Software to use to Map Process Maps, Process Mapping and Turtle Diagrams 12
S Software Validation – Clause 4.1.6 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Could I combine IQ, OQ and PQ for Minitab Software Validation ? Software Quality Assurance 3
R Document Management Software : Validation and other requirements Medical Information Technology, Medical Software and Health Informatics 8
K What are the minimum requirements for Process Validation (Software)? ISO 13485:2016 - Medical Device Quality Management Systems 5
R ISO - Clause 7.5.1.3 - CMM Software Program Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Validation Software Experience? (Valgenesis, etc.) Quality Assurance and Compliance Software Tools and Solutions 1
M Injection Molding Machine Software Validation Calibration and Metrology Software and Hardware 2
E FDA Requirements for Implantable Medical Device Software Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2

Similar threads

Top Bottom