Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.
Data Integrity II - Chromatography data system (CDS) in PharmaSathish Vemula
- Introduction
- Functions of CDS
- Validation of CDS
- Regulatory requirements
- Procedures required
- Areas for ensuring CDS Data Integrity
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to CDS
- EU – Non compliance Reports
- WHO - Notice of Concern
- How to avoid observations ?
- Conclusion
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceGreenlight Guru
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Best Practices for Implementing Automated Functional TestingJason Roy
In the fast-paced world of software development, automated functional testing has become indispensable for ensuring the quality and reliability of applications. However, implementing automated testing effectively requires careful planning, strategic execution, and adherence to best practices. This comprehensive guide explores the key principles and strategies for successfully implementing automated functional testing in your organization.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Similar to Process and Regulated Processes Software Validation Elements (20)
Building a Raspberry Pi Robot with Dot NET 8, Blazor and SignalR - Slides Onl...Peter Gallagher
In this session delivered at Leeds IoT, I talk about how you can control a 3D printed Robot Arm with a Raspberry Pi, .NET 8, Blazor and SignalR.
I also show how you can use a Unity app on an Meta Quest 3 to control the arm VR too.
You can find the GitHub repo and workshop instructions here;
https://bit.ly/dotnetrobotgithub
MATHEMATICS BRIDGE COURSE (TEN DAYS PLANNER) (FOR CLASS XI STUDENTS GOING TO ...PinkySharma900491
Class khatm kaam kaam karne kk kabhi uske kk innings evening karni nnod ennu Tak add djdhejs a Nissan s isme sniff kaam GCC bagg GB g ghan HD smart karmathtaa Niven ken many bhej kaam karne Nissan kaam kaam Karo kaam lal mam cell pal xoxo
MATHEMATICS BRIDGE COURSE (TEN DAYS PLANNER) (FOR CLASS XI STUDENTS GOING TO ...
Process and Regulated Processes Software Validation Elements
1. Process and Regulated Processes
Software Validation Elements
Arta Doci
Managing Director, Quality Arete Group
2. Agenda
• For what systems does FDA require Software
Validation?
• Regulatory Requirements
• Benefits of Software Validation
• Intended Use and the Requirements for Fulfilling
Intended Use
• Design Controls
• Product Development Process with Design Controls
• Validation of Non Device Software
• Device Software Validation
• Device Software Validation – Case Study
Quality Arete Group 10/13/2014 2
3. For what systems does FDA require
Software Validation?
Software that is part of the:
1. Manufacturing Process
2. Quality System
3. Medical Device
Quality Arete Group 10/13/2014 3
4. Requirements
• The production and Process Control subpart of the QSR
for medical devices requires that software be validated
and that process include appropriate risk analysis
• Establish a software life cycle model. The model should
cover the software lifecycle from design to retirement.
• Whenever computers or automated data processing
systems are used as part of production or the Quality
Systems, manufacturers must validate the software for its
intended use according to an established protocol
• All software changes must be validated before approval
and implementation
• The procedures of the validation and its results must be
documented
Quality Arete Group 10/13/2014 4
5. Benefits of Software Validation
Critical tool to ensure regulatory requirement, product quality, and
product reliability. In addition, it can reduce long term costs by making it
easier and less costly to reliably modify software and revalidate software
• Decrease failure rates
• Fewer consumer complaints
• Fewer recalls and corrective actions
• Less risk to patient
• Reduced liability to manufacturers
10/13/2014 5
changes
Quality Arete Group
6. Intended Use and the Requirements for
Fulfilling Intended Use
• Intended use for a medical device is usually related to a
diagnostic or therapeutic use, and ancillary use from
other stakeholders.
• Intended use for non device software (software that
automates part of the production or quality system) –
describes the part of the production or quality system
that it automates.
• Components of intended use:
o Who uses the software?
o Where is the software used?
o When is the software used in the process?
• Requirements are Verified; Intended Use is Validated
• Requirements Support Intended Uses
Quality Arete Group 10/13/2014 6
8. Product Development Process (example)
Concept Feasibility Development Qualification Launch
8
Risk Management
Design Outputs
Design Verification
Design Transfer
Design Inputs
Design Validation
Design Control Change
Design History File
Quality Arete Group 10/13/2014
9. Validation
FDA: Establishing documented evidence which provides a high degree
of assurance that a specific process will consistently produce a
product meeting predetermined specifications and quality attributes.
ISO-9000-2005: Confirmation by the provision of objective evidence
that the requirements for a specific use or a specific intended
application have been met.
EU GMP Guideline: Establishment of evidence in accordance with the
rules of ”Good Manufacturing Practice” that procedures, processes,
items of equipment, materials, operations or systems do in fact result in
the intended outcomes.
WHO: Establishing of documented evidence which provides a high
degree of assurance that a planned process will consistently perform
according to the intended specified outcomes.
Quality Arete Group 10/13/2014 9
11. Validation of Non Device Software
1. Life Cycle Planning (Determine the lifecycle model
to use)
2. Needs and Requirements Identification
3. Product & Vendor Selection
4. Acquisition
5. Test
6. Deployment and Training
7. Maintenance
8. Retirement
Quality Arete Group 10/13/2014 11
12. Validation of Non Device - Spreadsheet
1. Intended Use and Requirements
2. Design and Implementation
3. Test
4. Maintenance
5. Retirement
Quality Arete Group 10/13/2014 12
13. Example: Spreadsheet Validation
• Protect data throughout the data retention period
o Password protection
o Audit trails
o Electronic signatures
o Security – limited access
o Test calculations, test macros, and VBA scripts
o Code (version control) management
Quality Arete Group 10/13/2014 13
15. Software Development Process
Repeatable and efficient process that supports the development of a safe and effective
medical device compliant with applicable regulations and standards. IEC 62304:
10/13/2014 15
Quality Arete Group
16. Software Development Process …
• Software Development Planning – processes used in
development, deliverables developed, configuration
management, software system verification
• Software Requirements Analysis
o Risk Management – identify possible hazards and mitigations to be addressed
by software
o Software Requirements – expected behavior of the software system (Software
requirements document and Trace Matrix)
o Software specifications – critical design decisions
o Software safety classification
• Software Architecture Design
• Software Detailed Design
• Software Unit Implementation and Verification
• Software Integration and Integration Testing
• Software System Testing
• Software Release
• Software Maintenance
Quality Arete Group 10/13/2014 16
19. Goals: Software Focus
System validation of the Java-Based server system application,
which supports management of diverse clinical studies, and
ensures:
Clinical Data Entry and Validation
Data Extraction
Study oversight, auditing, and reporting
Trial Database is complete, accurate, and a true representation
of what took place in the trial
Trial database is sufficiently clean to support the statistical
analysis and its interpretation.
Quality Arete Group 10/13/2014 19
20. Goals: Ensure Data Quality
“Data quality” refers to the essential characteristics of each piece of data; in particular,
quality data should be:
• Accurate
o Trial database accurately captures the source data
o Any corrections or changes are documented
o Audit trail
• Legible
o Clear handwriting on CRFs
o Do not obliterate information when making changes/corrections
o All data (including meta-data and audit trails) must be in human-readable form
• Complete and Contemporaneous
o Avoid blank data fields or provide explanation (e.g. unknown, unobtainable, not applicable)
o Data must recorded at the time the activity occurs
o Audit trails to provide evidence of timing
• Original
o Original data (e.g. lab results, study questionnaires
o Accurate transcriptions of source data
• Attributable to the person who generated the data
o Who recorded the information
o Only designated study staff should have access to data
o Audit trail!
WHO Handbook for Good Clinical Research Practice
(GCP) : Guidance for Quality Arete Group Implementation, 2005 10/13/2014 20
21. Software Development Lifecycle (example)
Adapted from GAMP V-Model
21
User Requirement
Specification (URS)
User Acceptance Testing,
Validation (UAT, Val. Prot.)
Validation and Verification
Testing (RN, Ver. Prot.)
System Testing
(Regression)
Integration Testing
(I&T)
Unit Testing
(Junit, Nunit, etc.)
Validation
Verification
Informal
Verification
Informal
Verification
Software Requirement
Specification (SRS)
Software Architecture
Specification (SAS)
Detailed Design Document
(DDD)
Build (Coding, Config.,
Customization)
Business Owner
Software Engineering
Quality Assurance
Verification
Confirmation that the software is
built correctly (to specification)
Validation
Confirmation that the right software
was built (satisfies requirements)
Informal
Verification
Quality Arete Group 10/13/2014
22. Security - Limited Access
• Each user of the system has an individual account
• The user logs in their account at the beginning of a data
entry session, inputs information (including changes) on
the electronic record, and logs out at the completion of
data entry session
• The system limits the number of log-in attempts (3) and
records unauthorized access log-in attempts
• The system does not allow an individual to log onto the
system to provide another person access to the system.
• Passwords or other access keys be changed at
established intervals commensurate with a documented
risk assessment
• System automatically logs user off for long idle periods.
For short periods of inactivity, an automatic screen saver
prevent data entry until a password is entered
Quality Arete Group 10/13/2014 22
23. Security – Audit Trails
• System generates computer-generated, time-stamped
audit trails related to the creation,
modification, or deletion of electronic records and
may be useful to ensure compliance with the
appropriate regulation.
• Audit trails describe when, by whom, and the
reason changes were made to the electronic
record.
Quality Arete Group 10/13/2014 23
24. Disaster Recovery
• Implemented a disaster recovery policy and
backed up data in regular intervals.
• Mirrors provided an alternative means of accessing
key components of software, should primary servers
be temporarily unavailable
Quality Arete Group 10/13/2014 24
25. Risk Approach
Three main areas that could cause your clinical study
data to be at risk:
System LIMS behaves as expected
Process Quality control steps, SOPs, policy
Accessibility People, roles, restricted access to
the clinical study data
Quality Arete Group 10/13/2014 25
28. Requirements Checking
Validity. Does the system provide the
functions which best support the customer’s
needs?
Consistency. Are there any requirements
conflicts?
Completeness. Are all functions required by
the customer included?
Realism. Can the requirements be
implemented given available budget and
technology
Verifiability. Can the requirements be
checked?
Quality Arete Group 10/13/2014 28
29. Example Requirements
29
SRS 1 LIMS SHALL ASSIGN ACCESSIONING NUMBER USING THE FOLLOWING
FORMAT:“VSL<LABID>CYYYYMMDD-XXX”. WHERE <LABID> EQUALS A
UNIQUE IDENTIFIER FOR THE LAB AND YYYYMMDD EQUALS TODAY’S DATE
AND XXX EQUALS 001 FOR THE FIRST SAMPLE OF THAT DAY AND
INCREMENTS BY 1 FOR EACH ADDITIONAL SAMPLE THAT DAY.
SRS 2 LIMS shall display a barcode printer selection dialog that lists available barcode
printers.
SRS 3 LIMS shall display an error if the user does not select a barcode printer.
SRS 4 LIMS shall display an error if the selected barcode printer is not found.
Quality Arete Group 10/13/2014
31. Software V&V
Verification: "Are we building the product right"
The software should conform to its specification
Validation: "Are we building the right product"
The software should do what the user really requires
GOALS:
Verification and validation should establish confidence that the
software is fit for purpose
This does not mean completely free of defects
Rather, it must be good enough for its intended use
The type of use will determine the degree of confidence
that is needed
Quality Arete Group 10/13/2014 31
33. Requirement Validation
33
• Via Test Case Generation
Enter 2 samples to add and click the “Submit”
button.
Verify LIMS adds correct number of samples and
assigns accessioning numbers in this format:
“VSL<LABID>YYYYMMDD-XXX” where
(a) <LABID> Equals ‘C’
(b) YYYYMMDD equals today’s date
(c) XXX equals 001 for the first sample of that day and
increments by 1 for each additional sample that day.
SRS 1
Click on Task # 2. Visually inspect the GUI and verify LIMS displays the
Update Shipping Info screen.
Enter "Update Shipping Info" and check the
“Replicate” button.
Visually inspect the GUI and verify LIMS moves to next
task.
Click on Task # 3. Verify LIMS displays the barcode printer selection dialog
that lists available barcode printers.
SRS 2
Click Cancel (Do not select any of the printers) Verify an error dialog box displays informing the user
that a barcode printer much be selected.
SRS 3
Quality Arete Group 10/13/2014
34. Tools
• Subversion: Code Management
• JIRA: Defect Tracking and Requirement Traceability
• JTest: Testing and static code analysis
• Spreadsheets: Use data to make quality and GxP
decisions
• Minitab: Software FMEA and Trial Randomization
• LIMS: (Clinical) Laboratory Information
Management System
Quality Arete Group 10/13/2014 34
35. Test Cases
Test case examples:
• Direct Entry of Data:
o Test all the prompts, flags, or other help features into your computerized
system to encourage consistent use of clinical terminology and to alert
the user to data that are out of acceptable range.
o Use programming features that permit repopulation of information
specific to the subject.
• Retrieved data regarding each individual subject in
a study is attributable to that subject.
o Test: Reprocess data from a study that can be fully reconstructed from
available documentation.
Quality Arete Group 10/13/2014 35
36. Conclusion
In addition to operating in a competitive
marketplace with increasing end-user demands for
features and usability, medical device manufacturers
operate in a highly regulated environment.
Regulatory bodies look for evidence that medical
devices are developed under a structured, quality-oriented
development process. By following software
validation and verification best practices, one can
not only increase the likelihood that they will meet
their compliance goals, they can also enhance
developer productivity.
36
Quality Arete Group 10/13/2014
38. Scenario:
A diagnostic company, after having visited several times buy vs. in-house option
for a Clinical Data Management System, has decided to implement in-house a
custom software application to manage clinical trial data and analysis. The
requirements for the software are not fully identifiable in advance; therefore,
continual feedback from the Clinical Development and Laboratory Operations
groups will be needed.
Define the elements and supporting content that would be needed to meet
software validation regulatory requirements. Establish approach and provide
details needed to complete a validation plan for the following example.
o Please note if additional information is needed to properly define plan.
o Use either FDA guidance or ISO standards in helping to define process
validation activities.
Quality Arete Group 10/13/2014 38