This document debunks 7 common myths about validating software-as-a-service (SaaS) applications in a regulated environment. It explains that cloud providers can securely store data in specific geographic locations and use encryption. It also argues that virtual servers can be validated through traceable IDs and documented system development processes. Further, pre-validated multi-tenant systems and vendor-managed updates may not require revalidation if changes are properly tested and controlled. The document aims to demonstrate that SaaS applications can meet regulatory requirements if the appropriate security, documentation and change controls are implemented and audited.
In this presentation from IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Chris Wubbolt and John Patterson focus on current trends in cloud computing environments, including aspects of cloud computing and Software-as-a-Service (SaaS) providers that may be of interest to US Food and Drug Administration investigators during an FDA inspection. Important compliance related points to consider for software vendors as they shift to becoming SaaS providers are discussed. The presentation also reviews the pros and cons of cloud computing from a business and compliance perspective, including differences between traditional computing environments and private/public clouds. Examples of issues to consider when using cloud computing environments and SaaS providers are also discussed.
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.
In this presentation from IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Chris Wubbolt and John Patterson focus on current trends in cloud computing environments, including aspects of cloud computing and Software-as-a-Service (SaaS) providers that may be of interest to US Food and Drug Administration investigators during an FDA inspection. Important compliance related points to consider for software vendors as they shift to becoming SaaS providers are discussed. The presentation also reviews the pros and cons of cloud computing from a business and compliance perspective, including differences between traditional computing environments and private/public clouds. Examples of issues to consider when using cloud computing environments and SaaS providers are also discussed.
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.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
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.
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.
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.
Validating SharePoint for Regulated Life Sciences ApplicationsMontrium
Validating SharePoint for Regulated Life Sciences Applications
Presented by Paul Fenton, CEO & President, Montrium
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
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
Process and Regulated Processes Software Validation ElementsArta Doci
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.
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.
How to Spot a Good Document Control SystemEtQ, Inc.
Document Control is probably one of the most sought after applications when people are looking for a Quality Management or Environmental Health and Safety system.
In just 5 minutes, we'll uncover some of the common features to look for when selecting a good Document Control System.
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.
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
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.
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.
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.
Validating SharePoint for Regulated Life Sciences ApplicationsMontrium
Validating SharePoint for Regulated Life Sciences Applications
Presented by Paul Fenton, CEO & President, Montrium
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
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
Process and Regulated Processes Software Validation ElementsArta Doci
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.
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.
How to Spot a Good Document Control SystemEtQ, Inc.
Document Control is probably one of the most sought after applications when people are looking for a Quality Management or Environmental Health and Safety system.
In just 5 minutes, we'll uncover some of the common features to look for when selecting a good Document Control System.
2009 ARMA Toronto Symposium - Document Control on Capital Projects - Paper to...Keith Atteck C.Tech. ERMm
This case study describes the decade long experience of implementing document control on major capital projects at Inco and Vale in the mining industry. Topics include information management business issues facing the company, the RIM Program implementation, our document control practice, document management system utilization, Adobe Acrobat usage, DM Workflow, The change of mindset, and the journey complete with lessons learned.
IBM Messaging Security - Why securing your environment is important : IBM Int...Leif Davidsen
Presentation from IBM InterConnect 2016 . With growth in the number of business applications and exponential growth in connectivity between applications and systems, it is important to understand not just how to implement security, but why it is important to ensure all parts of the business can appreciate it and apply the right levels of security to their messaging system use. - jointly presented by Leif Davidsen and Rob Parker
3433 IBM messaging security why securing your environment is important-feb2...Robert Parker
These slides were presented at Interconnect with Leif Davidsen presenting why securing your environment is important and then i presented what security features in IBM MQ can be used to protect your environment.
ControlCase discusses the following in the context of PCI DSS and PA DSS
- Network Segmentation
- Card Data Discovery
- Vulnerability Scanning and Penetration Testing
- Card Data Storage in Memory
ControlCase discusses the following in the context of PCI DSS and PA DSS:
– Network Segmentation
– Card Data Discovery
– Vulnerability Scanning and Penetration Testing
– Card Data Storage in Memory
45 Minutes to PCI Compliance in the CloudCloudPassage
Join CloudPassage CEO, Carson Sweet and Sumo Logic Founding VP of Product & Strategy, Bruno Kurtic, for a webinar on “45 minutes to PCI Compliance in the Cloud”.
What You Will Learn:
-Understand the typical challenges faced by enterprises for achieving PCI on cloud infrastructure
-Learn how purpose-built SaaS-based cloud security solutions can save you tens of thousands in audit costs by speeding your time to compliance
-Get a quick demo of the CloudPassage Halo and Sumo Logic solutions that provide the telemetry and query/reporting engines respectively for cloud PCI
There is an increasing trend witnessed in the cloud computing technology which has led to a lot of risks in preserving the Confidentiality, Integrity and Availability of data. The Cloud is now facing a lot of compliance requirements due to the sensitivity of the data that is being stored. View this presentation to understand the Cloud Compliance Requirements, Risks, Audit Processes and Methodologies involved in providing assurance.
This presentation was given by CA Anand Prakash Jangid at the Conference on Cloud Computing conducted by the Committee on Information Technology of the Institute of Chartered Accountants of India on 11th January 2014.
Your organisation’s data are now everywhere: on your servers and your desktop PCs; on your employees’ smart phones, tablet computers and laptops; on social networks; and in public clouds. Some of these data require special protection but they also need to be accessed remotely, which makes security a considerable challenge. Can you trust public clouds to keep your data safe and secure? Can you trust your own internal systems? And on what criteria and risk management strategies should you base your trust? -- Dr Mark Ian Williams's presentation at the April 2012 'Why Cloud? Why now?' conference at the headquarters of the Institute of Chartered of Accountants of England Wales.
A presentation in which we explore the influences pushing cloud adoption, potential barriers to adoption, how to overcome these, SharePoint in the cloud, and what the road map to the cloud might look like.
PCI stands for “Payment Card Industry”. which is comprised of representatives from the major card brands (Visa, MasterCard, American Express, Discover, JCB etc.) who came together to set minimum security requirements for protecting cardholder data.
To achieve this, they wrote a framework of security controls known as the PCI DSS. They wrote a number of other directives but this is the main one that applies to the majority of businesses.
The PCI DSS consists of six goals, 12 requirements and 286 controls and must be implemented by any business that processes, stores or transmits credit or debit card holder data. The requirement for PCI DSS compliance is stated in your agreement with the bank that issues you a merchant identification. Your business is required to certify compliance to your bank upon achieving it and annually thereafter. The banks report your compliance to the PCI SCC and can issues fines for non-compliance.
This 7-second Brain Wave Ritual Attracts Money To You.!nirahealhty
Discover the power of a simple 7-second brain wave ritual that can attract wealth and abundance into your life. By tapping into specific brain frequencies, this technique helps you manifest financial success effortlessly. Ready to transform your financial future? Try this powerful ritual and start attracting money today!
APNIC Foundation, presented by Ellisha Heppner at the PNG DNS Forum 2024APNIC
Ellisha Heppner, Grant Management Lead, presented an update on APNIC Foundation to the PNG DNS Forum held from 6 to 10 May, 2024 in Port Moresby, Papua New Guinea.
Bridging the Digital Gap Brad Spiegel Macon, GA Initiative.pptxBrad Spiegel Macon GA
Brad Spiegel Macon GA’s journey exemplifies the profound impact that one individual can have on their community. Through his unwavering dedication to digital inclusion, he’s not only bridging the gap in Macon but also setting an example for others to follow.
1.Wireless Communication System_Wireless communication is a broad term that i...JeyaPerumal1
Wireless communication involves the transmission of information over a distance without the help of wires, cables or any other forms of electrical conductors.
Wireless communication is a broad term that incorporates all procedures and forms of connecting and communicating between two or more devices using a wireless signal through wireless communication technologies and devices.
Features of Wireless Communication
The evolution of wireless technology has brought many advancements with its effective features.
The transmitted distance can be anywhere between a few meters (for example, a television's remote control) and thousands of kilometers (for example, radio communication).
Wireless communication can be used for cellular telephony, wireless access to the internet, wireless home networking, and so on.
# Internet Security: Safeguarding Your Digital World
In the contemporary digital age, the internet is a cornerstone of our daily lives. It connects us to vast amounts of information, provides platforms for communication, enables commerce, and offers endless entertainment. However, with these conveniences come significant security challenges. Internet security is essential to protect our digital identities, sensitive data, and overall online experience. This comprehensive guide explores the multifaceted world of internet security, providing insights into its importance, common threats, and effective strategies to safeguard your digital world.
## Understanding Internet Security
Internet security encompasses the measures and protocols used to protect information, devices, and networks from unauthorized access, attacks, and damage. It involves a wide range of practices designed to safeguard data confidentiality, integrity, and availability. Effective internet security is crucial for individuals, businesses, and governments alike, as cyber threats continue to evolve in complexity and scale.
### Key Components of Internet Security
1. **Confidentiality**: Ensuring that information is accessible only to those authorized to access it.
2. **Integrity**: Protecting information from being altered or tampered with by unauthorized parties.
3. **Availability**: Ensuring that authorized users have reliable access to information and resources when needed.
## Common Internet Security Threats
Cyber threats are numerous and constantly evolving. Understanding these threats is the first step in protecting against them. Some of the most common internet security threats include:
### Malware
Malware, or malicious software, is designed to harm, exploit, or otherwise compromise a device, network, or service. Common types of malware include:
- **Viruses**: Programs that attach themselves to legitimate software and replicate, spreading to other programs and files.
- **Worms**: Standalone malware that replicates itself to spread to other computers.
- **Trojan Horses**: Malicious software disguised as legitimate software.
- **Ransomware**: Malware that encrypts a user's files and demands a ransom for the decryption key.
- **Spyware**: Software that secretly monitors and collects user information.
### Phishing
Phishing is a social engineering attack that aims to steal sensitive information such as usernames, passwords, and credit card details. Attackers often masquerade as trusted entities in email or other communication channels, tricking victims into providing their information.
### Man-in-the-Middle (MitM) Attacks
MitM attacks occur when an attacker intercepts and potentially alters communication between two parties without their knowledge. This can lead to the unauthorized acquisition of sensitive information.
### Denial-of-Service (DoS) and Distributed Denial-of-Service (DDoS) Attacks
Multi-cluster Kubernetes Networking- Patterns, Projects and GuidelinesSanjeev Rampal
Talk presented at Kubernetes Community Day, New York, May 2024.
Technical summary of Multi-Cluster Kubernetes Networking architectures with focus on 4 key topics.
1) Key patterns for Multi-cluster architectures
2) Architectural comparison of several OSS/ CNCF projects to address these patterns
3) Evolution trends for the APIs of these projects
4) Some design recommendations & guidelines for adopting/ deploying these solutions.
1. GxP Validation In The
Cloud
Debunking The Most Popular Myths To Validating
SaaS Apps In A GxP Environment
By: Ed Morris, The Morris Group, LLC
2. Ed Morris, Managing Member
The Morris Group, LLC
2
• Twenty plus years consulting to Life Sciences clients related to regulatory compliance (21 CFR Part 210/211,
820, PDMA, GAMP, 21 CFR Part 11) Core expertise in system implementation and validation as well as data
management and analytics. Hands-on experience with validation strategy and IT governance related to new
architectures including Cloud, SaaS and SOA based systems. IT Quality Assurance related to Software
Development Lifecycle (SDLC) and change control
• Consulting Services
• Systems Implementation / Validation
• Audits and Assessments
• Remediation
• Technology Evaluation & Selection
• Performance Optimization
• Project Management
• Operational Domains
• Quality Assurance
• Pharmacovigilance
• Clinical Development
• Regulatory Affairs
• Manufacturing / Shop Floor
• Commercial Operations
• Current Projects
• IT Governance / Validation Strategy For Cloud
Based Clinical Data Management Platform
• Network security breach investigation /
remediation
• Clinical Vendor Qualification Audits
• For Cause audits / Root Cause Analysis
3. ZenQMS
3
• Jeff Thomas, Vice President email: jeff@zenqms.com
• ZenQMS offers a robust, affordable cloud-based QMS
• No Seat Licenses, Full access, Straightforward pricing
www.zenqms.com
4. • Software as a Service (SaaS)
Applications Allow For Easier & More
Affordable Implementations.
• Getting to SaaS requires an
understanding of the facts and the myths.
SaaS / Cloud Based Solutions
5. Myth 1:
My data is ‘floating’ around the Internet
5
• High availability gives the illusion that data
is “everywhere”
• Most Tier 1 cloud providers support the
ability to specify a geographic location or
region e.g. by country, state or city.
6. Myth 2:
My Data is Not Secure
6
• Often, cloud providers have multiple layers of security
including network and server based intrusion detection,
antivirus and malware systems.
• Data can be encrypted in-transit and at rest. The
majority of Tier 1 Cloud providers operate HIPAA
specific environments that are separate from the
general public cloud infrastructures
7. Myth 3: Without A Serial Number, a
Server Can’t Be Validated
7
● Traceability
● Virtual Machines should have a traceable
Instance ID
● Focus should be on the Systems Development
LifeCycle (SDLC)
● If SDLC follows GAMP V with a traceable ID, the
system can be considered compliant
8. Myth 4: There’s No Such Thing As A
“Pre-validated” System
• A validated system is less about the infrastructure or where it resides
and more about when it was installed and/or customized
• For instance, if a basic Customer Relationship Management (CRM)
system is installed and configured according to a set of base
requirements, it can be validated in that state.
• Theoretically, an organization can begin using the system provided
no changes are made to the configuration e.g. data fields, screens,
reports.
8
9. Myth 4: There’s No Such Thing As A
“Pre-validated” System (continued)
• Multi-tenant Systems. Execute a full validation of the “core system”
which is available for immediate use by new clients.
• Becomes the Gold Copy
• Any proposed configurations must be assessed for regulatory risk to
determine if additional validation is necessary.
• If so, the client specific user requirements are documented and a UAT
protocol is written and executed. Most user specific validations are
very brief and can be fully executed in just a few weeks.
9
10. Myth 5:
Cloud Providers Cannot Be Audited
• Physical audits of cloud data centers are typically not possible due to
strict premises security controls.
• TMG performs multiple IT QA audits per year. Rarely do they include
a detailed tour of the data center.
• Occasionally, we do make a brief visit to the data center to verify
certain controls such as physical access and fire suppression.
• Maintenance logs including backups, outages, patches and updates
are accessed outside of the data center itself.
1
0
11. Myth 5:
Cloud Providers Cannot Be Audited (cont’d)
• Twenty years ago, data centers were busy places with lots of
activity by operators running printers, loading tapes and launching
jobs. Today, all of those functions have been eliminated or
automated leaving data centers dark with no human presence
whatsoever
• If you were to audit a data center today what would you examine?
There’s just not much to see anymore
• The real audit is done through interviews with key personnel and
documentation reviews.
1
1
12. Myth 6:
I Am Not In Control Of My Data
● Control Vs. Possession?
○ Clients always own their data. It is their intellectual property.
○ The best way to control data is to manage its flow from entry, through
processing, storing, integration and archiving.
● All of this is defined in the SDLC of the given system by
documenting and testing integrations including:
○ Subscribers and Publishers – Unique Identification
○ Data Fields – Transport Mechanism - Encryption
○ Authentication - Boundaries
1
2
13. Myth 7: Automatic Software
Updates Require Re-validation
• Built-in maintenance and updates that come as part
of the subscription are one of the major values of a
SaaS or cloud based system.
• Your Vendor is responsible for change control and
re-validation if necessary
• Check with your vendor to understand frequency of
updates as well as the testing period available.
1
3
14. Review and Discussion
• Myth 1: My Data is ‘floating’ around the Internet
• Myth 2: My Data is Not Secure
• Myth 3: Without A Serial Number, a Server Can’t Be Validated
• Myth 4: There’s No Such Thing as A “Pre-validated” System
• Myth 5: Cloud Providers Cannot Be Audited
• Myth 6: I Am Not In Control Of My Data
• Myth 7: Automatic Software Updates Require Re-validation
15. Contact Information
• Ed Morris
• The Morris Group
• Ed.morris@themorrisgrp.com
• 973 713 2211
• www.themorrisgrp.com
• Jeff Thomas
• ZenQms
• jeff@zenqms.com
• 267 672 8999
• www.zenqms.com