As a pioneer in the development of automated validation software solutions, ValGenesis, Inc. leads the way with a unique paperless validation process that tracks the validation status of any GxP system in real time. With years of development and refinement in place,
ValGenesis is the first to offer users real-time paperless validation via electronic execution thereby minimizing ineffectiveness and maximizing efficiency.
ValGenesis automates and manages the validation life cycle and provides real time validation status of any system corporate wide.
Top 20 observation series # 3 21 CFR 211.192Sathish Vemula
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.192
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
- Batch Record Review - Investigations
If you’re involved with the life sciences industry, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but unless you work in a compliance group, you might not understand what it’s about or why it’s important.
In our webinar, Sally Miranker, head of computer system validation in Perficient’s life sciences practice, "decoded" the secrets of 21 CFR Part 11 on this somewhat mysterious set of regulations.
Building on our popular blog post series, Sally explained the regulations in layman’s terms and offered implementation insights and case study examples.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
Analytical Instrument Qualification forms the base for generating quality data. The USP chapter 1058 describes a scientific and risk-based approach to analytical instrument qualification. The 2017 revision is planned for publication on 1 December 2017.
Top 20 observation series 2: 21 CFR 211.22Sathish Vemula
- 2014 inspectional observations- List of Top observations in 2014- Sec. 21 CFR 211.22 (a) 21 CFR 211.22 (b) 21 CFR 211.22 (c) 21 CFR 211.22 (d) - 483 observations- Warning Letters- Other Guidance- How to avoid observations
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.
Top 20 observation series # 3 21 CFR 211.192Sathish Vemula
- 2014 inspectional observations
- List of Top observations in 2014
- Sec. 21 CFR 211.192
- 483 observations
- Warning Letters
- Other Guidance
- How to avoid observations
- Batch Record Review - Investigations
If you’re involved with the life sciences industry, odds are you’ve heard the term “21 CFR Part 11.” You may have gathered that it’s a set of regulations related to computer systems, but unless you work in a compliance group, you might not understand what it’s about or why it’s important.
In our webinar, Sally Miranker, head of computer system validation in Perficient’s life sciences practice, "decoded" the secrets of 21 CFR Part 11 on this somewhat mysterious set of regulations.
Building on our popular blog post series, Sally explained the regulations in layman’s terms and offered implementation insights and case study examples.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
Analytical Instrument Qualification forms the base for generating quality data. The USP chapter 1058 describes a scientific and risk-based approach to analytical instrument qualification. The 2017 revision is planned for publication on 1 December 2017.
Top 20 observation series 2: 21 CFR 211.22Sathish Vemula
- 2014 inspectional observations- List of Top observations in 2014- Sec. 21 CFR 211.22 (a) 21 CFR 211.22 (b) 21 CFR 211.22 (c) 21 CFR 211.22 (d) - 483 observations- Warning Letters- Other Guidance- How to avoid observations
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.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
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.
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
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.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
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.
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
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.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
At some stage or other, a business enterprise feels the need to implement QA processes to standardize their operations, product delivery, and empower business solutions. Maintaining a full-fledged QA standard process is vital for a product-based environment. If a given QA standard is followed in a proper way, it leads to well-defined, user-oriented, and quality products.
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.
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
How QEdge assist you to accelerate your ROI?SarjenSystems
QEdge provide you a single unified platform to streamline and automate your process, people, procedure and documentation for better transparency, control and performance.
User Acceptance Testing - Key Takeaways For BusinessesSerena Gray
There is a huge demand for quality software applications across the globe and thus there is a steady demand for implementing software testing processes in a result-oriented and rewarding manner. User acceptance testing is one of the best software testing types that validate the product’s worth from someone (an end-user) who is not a part of the internal staff or the team. Read more https://testingxpertsuk.blogspot.com/2022/03/user-acceptance-testing-key-takeaways.html
Veeva Systems Webinar: Driving Continuous Quality ImprovementsVeeva Systems
Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand
Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%.
Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas.
You will hear:
- Opportunities and recommendations to unify and streamline quality systems and processes
- Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster
- Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.
Quality assurance and testing _ H2kinfosys.pdfsharontims
Quality assurance and testing are integral components of the software development process, playing a pivotal role in ensuring the delivery of reliable, high-quality software products to end-users.
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Similar to Cost and Time savings through ValGenesis -Validation Software Solution (20)
Listen to the keynote address and hear about the latest developments from Rachana Ananthakrishnan and Ian Foster who review the updates to the Globus Platform and Service, and the relevance of Globus to the scientific community as an automation platform to accelerate scientific discovery.
In 2015, I used to write extensions for Joomla, WordPress, phpBB3, etc and I ...Juraj Vysvader
In 2015, I used to write extensions for Joomla, WordPress, phpBB3, etc and I didn't get rich from it but it did have 63K downloads (powered possible tens of thousands of websites).
Essentials of Automations: The Art of Triggers and Actions in FMESafe Software
In this second installment of our Essentials of Automations webinar series, we’ll explore the landscape of triggers and actions, guiding you through the nuances of authoring and adapting workspaces for seamless automations. Gain an understanding of the full spectrum of triggers and actions available in FME, empowering you to enhance your workspaces for efficient automation.
We’ll kick things off by showcasing the most commonly used event-based triggers, introducing you to various automation workflows like manual triggers, schedules, directory watchers, and more. Plus, see how these elements play out in real scenarios.
Whether you’re tweaking your current setup or building from the ground up, this session will arm you with the tools and insights needed to transform your FME usage into a powerhouse of productivity. Join us to discover effective strategies that simplify complex processes, enhancing your productivity and transforming your data management practices with FME. Let’s turn complexity into clarity and make your workspaces work wonders!
Developing Distributed High-performance Computing Capabilities of an Open Sci...Globus
COVID-19 had an unprecedented impact on scientific collaboration. The pandemic and its broad response from the scientific community has forged new relationships among public health practitioners, mathematical modelers, and scientific computing specialists, while revealing critical gaps in exploiting advanced computing systems to support urgent decision making. Informed by our team’s work in applying high-performance computing in support of public health decision makers during the COVID-19 pandemic, we present how Globus technologies are enabling the development of an open science platform for robust epidemic analysis, with the goal of collaborative, secure, distributed, on-demand, and fast time-to-solution analyses to support public health.
How Recreation Management Software Can Streamline Your Operations.pptxwottaspaceseo
Recreation management software streamlines operations by automating key tasks such as scheduling, registration, and payment processing, reducing manual workload and errors. It provides centralized management of facilities, classes, and events, ensuring efficient resource allocation and facility usage. The software offers user-friendly online portals for easy access to bookings and program information, enhancing customer experience. Real-time reporting and data analytics deliver insights into attendance and preferences, aiding in strategic decision-making. Additionally, effective communication tools keep participants and staff informed with timely updates. Overall, recreation management software enhances efficiency, improves service delivery, and boosts customer satisfaction.
Atelier - Innover avec l’IA Générative et les graphes de connaissancesNeo4j
Atelier - Innover avec l’IA Générative et les graphes de connaissances
Allez au-delà du battage médiatique autour de l’IA et découvrez des techniques pratiques pour utiliser l’IA de manière responsable à travers les données de votre organisation. Explorez comment utiliser les graphes de connaissances pour augmenter la précision, la transparence et la capacité d’explication dans les systèmes d’IA générative. Vous partirez avec une expérience pratique combinant les relations entre les données et les LLM pour apporter du contexte spécifique à votre domaine et améliorer votre raisonnement.
Amenez votre ordinateur portable et nous vous guiderons sur la mise en place de votre propre pile d’IA générative, en vous fournissant des exemples pratiques et codés pour démarrer en quelques minutes.
Innovating Inference - Remote Triggering of Large Language Models on HPC Clus...Globus
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Large Language Models and the End of ProgrammingMatt Welsh
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Software Engineering, Software Consulting, Tech Lead.
Spring Boot, Spring Cloud, Spring Core, Spring JDBC, Spring Security,
Spring Transaction, Spring MVC,
Log4j, REST/SOAP WEB-SERVICES.
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Graspan: A Big Data System for Big Code AnalysisAftab Hussain
We built a disk-based parallel graph system, Graspan, that uses a novel edge-pair centric computation model to compute dynamic transitive closures on very large program graphs.
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These analyses were used to augment the existing checkers; these augmented checkers found 132 new NULL pointer bugs and 1308 unnecessary NULL tests in Linux 4.4.0-rc5, PostgreSQL 8.3.9, and Apache httpd 2.2.18.
- Accepted in ASPLOS ‘17, Xi’an, China.
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- Invited for presentation at SoCal PLS ‘16.
- Invited for poster presentation at PLDI SRC ‘16.
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Globus Compute wth IRI Workflows - GlobusWorld 2024Globus
As part of the DOE Integrated Research Infrastructure (IRI) program, NERSC at Lawrence Berkeley National Lab and ALCF at Argonne National Lab are working closely with General Atomics on accelerating the computing requirements of the DIII-D experiment. As part of the work the team is investigating ways to speedup the time to solution for many different parts of the DIII-D workflow including how they run jobs on HPC systems. One of these routes is looking at Globus Compute as a way to replace the current method for managing tasks and we describe a brief proof of concept showing how Globus Compute could help to schedule jobs and be a tool to connect compute at different facilities.
May Marketo Masterclass, London MUG May 22 2024.pdfAdele Miller
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This is a MUG with a twist you don't want to miss.
Check out the webinar slides to learn more about how XfilesPro transforms Salesforce document management by leveraging its world-class applications. For more details, please connect with sales@xfilespro.com
If you want to watch the on-demand webinar, please click here: https://www.xfilespro.com/webinars/salesforce-document-management-2-0-smarter-faster-better/
Prosigns: Transforming Business with Tailored Technology SolutionsProsigns
Unlocking Business Potential: Tailored Technology Solutions by Prosigns
Discover how Prosigns, a leading technology solutions provider, partners with businesses to drive innovation and success. Our presentation showcases our comprehensive range of services, including custom software development, web and mobile app development, AI & ML solutions, blockchain integration, DevOps services, and Microsoft Dynamics 365 support.
Custom Software Development: Prosigns specializes in creating bespoke software solutions that cater to your unique business needs. Our team of experts works closely with you to understand your requirements and deliver tailor-made software that enhances efficiency and drives growth.
Web and Mobile App Development: From responsive websites to intuitive mobile applications, Prosigns develops cutting-edge solutions that engage users and deliver seamless experiences across devices.
AI & ML Solutions: Harnessing the power of Artificial Intelligence and Machine Learning, Prosigns provides smart solutions that automate processes, provide valuable insights, and drive informed decision-making.
Blockchain Integration: Prosigns offers comprehensive blockchain solutions, including development, integration, and consulting services, enabling businesses to leverage blockchain technology for enhanced security, transparency, and efficiency.
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Join us on a journey of innovation and growth. Let's partner for success with Prosigns.
Prosigns: Transforming Business with Tailored Technology Solutions
Cost and Time savings through ValGenesis -Validation Software Solution
1.
PDA awarded ValGenesis the New Innovative Technology award for
Paperless Validation Lifecycle Management Technology
Benefits of an
Electronic Validation Lifecycle Management System
in the CorporateValidation Process –
Validation CycleTime and Cost Perspective
EVLMbenefits.indd 1 2/16/11 9:23 AM
2. Regulated Pharmaceutical, Biotech and Medical Device companies are challenged to develop manufacturing capabilities
quickly and cost-effectively, while 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 the manual
approach to validation. Over time the traditional validation activities have become centered on documentation, which has
increased and led to additional quality issues. For the most part, validation still requires a high degree of manual effort, for
tracking and reporting, and the execution of most validation protocols takes place on paper.
Traditional validation activities using paper-based validation processes stifle innovation, cause compliance risks and
compromise a life science firm’s ability to bring products to the market on time. Inefficiencies in the validation process
cost regulated manufacturers millions of dollars annually, mainly attributed to the use of paper, or paper/hybrid electronic
systems. These manual, or hybrid, labor-intensive systems are proven to be error-prone, delay time-to-market and
introduce product quality problems that risk stringent regulatory penalties.
Validation lifecycle activities are separated into the following two major categories, for efficiency estimation,
1. Core Validation activities 2. Supporting Validation activities
1.0 Core Validation activities:
Core validation activities constitute 80% of the overall Validation Lifecycle. The following are the core validation
constituents and the associated effort required for the validation lifecycle.
1.1 Creating, reviewing and approving Validation plans and projects – 5%
1.2 Authoring, reviewing and approving Validation protocols – 25%
1.3 Creating and maintaining traceability matrices and requirements – 10%
1.4 Executing, reviewing and approving Validation protocols – 25%
1.5 Risk assessment, review approval and maintaining the Validation status -10%
1.6 Creating and maintaining periodic review and revalidation schedules – 5%
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
EVLMbenefits.indd 2 2/16/11 9:23 AM
3. # Current Process Impact of ValGenesis Efficiency Gain
1.1 Creating, reviewing and approving Validation plan and projects –
5% of the effort in the Validation Lifecycle Process
1.1.1 Validation Plans and projects are created
manually and routed for review and
approvals through inter-office mail.
Approved validation plans are available
as reference but cannot be enforced in
the process.
Validation plans and projects can be developed electronically
and routed for review and approval through workflow.
Approved Validation plan and requirements are enforced in the
process and eliminate the risk of noncompliance
Given these advantages
of creating validation
plans and projects
in ValGenesis, it is
expected to achieve a
20-30% efficiency gain
in this area.
1.2 Authoring, reviewing and approving Validation protocols –
25% of the effort in the Validation Lifecycle Process
1.2.1 In a paper environment, once a
document has been authored or
executed, it must be physically sent
to the corresponding reviewers or
approvers through inter-office mail, or
other delivery options. Paper documents
can be misplaced or lost, causing time
to be spent searching for, or replacing
documents.
Furthermore, routing documents from
one location to the next, adds additional
delays. There will be a number of
reviewers and approvers. Documents
have to be routed to each reviewer, or
approver, in a serial flow.
In ValGenesis authored documents are routed electronically and
are available for review and approval in real time. ValGenesis
supports routing in parallel, serial and a combination of parallel
and serial (hybrid) reviews and approvals, to expedite the final
approval process. Every document, its history and current status
are available electronically ensuring solid and secure document
control.
Parallel Review - Documents can be reviewed in parallel,
whereby all reviewers can review documents at the same time.
Combination of Parallel and Serial Review: Documents can be
reviewed in parallel by the first few reviewers and approvers,
the final approval can be done in serial (one QA Approver for
example).
ValGenesis supports the reuse of requirements and developed
protocols, through a binding process, for entities to be validated.
Given these advantages
of authoring, reviewing
and approving
validation documents
in ValGenesis, it is
expected to achieve a
20-30% efficiency gain
in this area.
1.2.2 In the current process, there is no
method available to alert reviewers and
approvers regarding target dates, or any
delay in the process.
It is difficult to transfer the tasks to other
reviewers and approvers, in the event of
delay.
Alert Notification - Reviewers are alerted, in real time, of any
waiting review or approval task, through corporate email.
1.2.3 Physical access to the document is
required for review, or approval of the
document.
Review or approval is delayed if the
reviewer or approver is not available.
No Physical access is required; documents can be sent securely
through corporate networks.
1.3 Creating and maintaining traceability matrices and requirements –
10% of the effort in the Validation Lifecycle Process
1.3.1 Creating and maintaining a traceability
matrix through a manual process is
extremely time consuming. The traces
between requirements and test cases are
generally buried in the paper and cannot
provide any real time information, or
impact assessment.
Traceability Matrices can be created dynamically within few
mouse clicks in ValGenesis. The Traceability Matrix function
within ValGenesis improves change management by providing
an accurate assessment of its impact, by identifying related
requirements, design elements, and test scripts. In addition, it
helps to scope the regression testing clearly and accurately.
During test case execution, the deviations observed in a test
case can be tracked and traced back to the associated design
elements in the Traceability Matrix.
During audits and inspections, the Traceability Matrix provides a
clear, real-time view of the trace between requirements, design
elements and test cases.
Given these
advantages of creating
and maintaining
requirements and
traceability matrices
in ValGenesis, it is
expected to achieve a
40-50% efficiency gain
in this area.
1.3.2 Developing requirements takes significant
effort and coordination between all
users.
Requirements are subject to frequent
changes and version control should
be adopted. It is time-consuming and
difficult to maintain requirements in the
paper-based process
ValGenesis provides a collaborative approach to effectively
communicate with all users, through a requirements bulletin
board, reducing the time to complete the requirement
gathering process.
ValGenesis provides the functionality to maintain the
requirements, with version control. This approach provides
much more control and significantly reduces the time to
maintain the requirements.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
EVLMbenefits.indd 3 2/16/11 9:23 AM
4. # Current Process Impact of ValGenesis Efficiency Gain
1.4 Executing, reviewing and approving Validation protocols –
25% of the effort in the Validation Lifecycle Process
1.4.1 Documents have to be executed
manually with pen and paper. Screen
shots have to print through a printer and
attached, with the executed document,
as attachments. Supporting files, such as
reports, will also be attachments to the
executed document.
Documents are executed electronically and screen shots are
attached at the test case row level. Files can also be attached at
the row level.
Given these advantages
of executing, revising
and approving
validation documents
in ValGenesis, it is
expected to achieve a
40-50% efficiency gain
in this area.
1.4.2 Deviations or exceptions are handled
manually through paper-based
documents. Each deviation will be
handled through a separate time-
consuming paper-based workflow.
Deviations are handled electronically and the deviation
workflows are concurrent for any number of deviations, this will
expedite the execution process.
1.4.3 Hand-writing can be difficult to read and
may contain typographical errors
ValGenesis provides spell-checking and all content is electronic
and easy to read.
1.4.5 Once the document has been executed
it must be physically sent to the
reviewers or approvers, through inter-
office mail, or other delivery options.
Furthermore, routing documents from
one location to the next adds additional
delays. There will be a number of
reviewers and approvers. The documents
have to be routed to one reviewer or
approver in a serial flow.
In ValGenesis executed documents are routed electronically
and are available for review and approval in real time.
ValGenesis supports parallel, serial and combination of parallel
and serial (hybrid) review and approval, to expedite the process.
Parallel Review – Executed documents can be reviewed in
parallel; whereby all reviewers can review the document at the
same time.
Combination of Parallel and Serial Review: Executed documents
can be reviewed in parallel by the first few reviewers and
approvers, the final approval can be done in serial (one QA
Approver for example).
ValGenesis supports the reuse of requirements and developed
protocols, through a binding process with other entities, to be
validated.
1.4.6 There is no automated method to alert
reviewers and approvers regarding target
dates, or delays in the process.
It is difficult to transfer the tasks to other
reviewers or approvers, in the event of a
delay.
Alert Notification - Reviewers are alerted in real time of any
review or approval task, through corporate email.
Tasks may be transferred to other reviewers and approvers
automatically should there be a delay
Management is notified of delays and can take any necessary
action.
1.4.7 Physical access to the executed
document is required for review, or
approval.. Review or approval is delayed
if a reviewer or approver is not available.
No physical access is required; documents can be approved
through secure corporate networks.
1.4.8 There is great potential to misplace or
lose executed document during transfers
Documents are available in electronic format and are stored
centrally for easy access.
1.5 Risk assessment, review, approve and maintain the validation status -
10% of the effort in the Validation Lifecycle Process
1.5.1 Risk assessment is manual and again
generally paper-based; this requires
information from a number of different
systems, or departments. This is a time-
consuming and error-prone process.
ValGenesis brings together all the impacts associated with the
validated systems/entities for assessment. For example, the
associated change requests, upcoming revalidation/periodic
review etc. are pulled together. This means all the impacts can
be brought together in fewer documents electronically.
Given these advantages
of managing the risks
in ValGenesis, it is
expected to achieve a
40-50% efficiency gain
in this area.
1.5.2 Approval of risk assessment is generally
managed through manual and paper-
based processes, it is extremely time-
consuming.
ValGenesis provides comprehensive workflow capabilities to
manage the risk assessment.
1.5.3 There are no automated alerts for SMEs
should there be any impact on the
validation status of systems/entities.
ValGenesis automatically alerts SMEs if there is any impact.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
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5. # Current Process Impact of ValGenesis Efficiency Gain
1.6 Create and maintain periodic review and revalidation schedules –
5% of the effort in the Validation Lifecycle Process
1.6.1 Periodic review and revalidation
schedules are maintained in paper. It is
very time-consuming and error-prone.
ValGenesis provides a dynamic validation calendar for
upcoming and delayed periodic reviews and revalidations
Given these advantages
of maintaining periodic
review and revalidation
schedules in ValGenesis,
it is expected to achieve
a 40-50% efficiency
gain in this area.
1.6.2 Periodic review and revalidation
schedules are generally approved
through a paper-based process.
Workflow-driven review and approval for Periodic review and
revalidation schedules.
1.6.3 No automatic alerts for upcoming, or
delayed, revalidation or periodic review
schedules.
ValGenesis provides automatic alerts for upcoming and delayed
periodic reviews and revalidations; this helps to eliminate the
possibility of missing a validation task due to human-error.
2. Supporting Validation Activities:
Supporting validation activities consist of 20% of the overall Validation Lifecycle. The following are the supporting
validation activities and associated effort required in the validation lifecycle.
2.1 Tracking the validation status for decision-making 10%
2.2 Audit preparation for internal and external audits – 3%
2.3 Document retrieval – 2%
2.4 Validation metrics for resource and budget planning – 5%
# Current Process Impact of ValGenesis Efficiency Gain
2.1. Tracking the validation status for decision-making
2.1.1 In a paper-based system, tracking is difficult
at best, as it often requires e-mails, or phone
calls, to prospective reviewers, approvers, and
document specialists.
ValGenesis is equipped with built-in tracking functions,
designed to enable users to locate an authored, or
executed document easily and in real time. These
functions include development and execution pie-charts
from the dashboard, inventory manager with search
capabilities, barcode scanning from the production floor,
and transparent audit trails available to any user involved
with developing, execution, reviewing, or approving any
document.
Given these
advantages of real
time tracking functions
in ValGenesis, it is
expected to achieve
a 70-80% efficiency
gain in this area.
2.2 Audit preparation for internal and external audits
2.2.1 With paper-based systems, audit preparation
is much more cumbersome, given that
documents must be located in a physical
document repository. Furthermore, when
documents are not available, there is
additional delay in physically routing the
document to the intended receiver.
All documents are generated electronically in ValGenesis
and can be retrieved from the system’s electronic
repository (Library), in real time. This means users can be
prepared for audits with very little effort finding documents
in a few mouse clicks.
Given these
advantages of audit
readiness through
ValGenesis, it is
expected to achieve
a 80-90% efficiency
gain in this area.
2.3 Document retrieval
2.3.1 Documents have to be searched and retrieved
from a physical document storage location.
This method has a high cost of maintenance
and needs extra resources.
Documents can be retrieved in real time. Documents are
available electronically in real time. There is no need for
physical document storage and the resources to manage
them.
Given these
advantages of
ValGenesis, in terms of
document availability
and retrieval, it is
expected to achieve
a 70-80% efficiency
gain in this area.
Benefits of an Electronic Validation Lifecycle Management System in the Corporate Validation Process
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