This presentation identifies a way to use Risk Management to determine the extent and scope of a validation project, including what validation documents are needed and what should be tested. One validation size does not fit all validation projects! Using the Quality/Regulatory Risk and Functionality/Distribution Risk identifies an Overall System Risk. The Overall System Risk and the Type of System Change determine the needed Validation documents. A methodology to identify the extent of validation test scripts is discussed too.
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.
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.
Risked Based Validation of EDMS - DIA PresentationMontrium
Overview of a risk based approach for validating an EDMS
•Identify regulatory requirements which apply to an EDMS
•Discuss high risk system functionality which must be validated
•Practical Example
•Good practices for maintaining a validated state via configuration and change control
This presentation identifies a way to use Risk Management to determine the extent and scope of a validation project, including what validation documents are needed and what should be tested. One validation size does not fit all validation projects! Using the Quality/Regulatory Risk and Functionality/Distribution Risk identifies an Overall System Risk. The Overall System Risk and the Type of System Change determine the needed Validation documents. A methodology to identify the extent of validation test scripts is discussed too.
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.
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.
Risked Based Validation of EDMS - DIA PresentationMontrium
Overview of a risk based approach for validating an EDMS
•Identify regulatory requirements which apply to an EDMS
•Discuss high risk system functionality which must be validated
•Practical Example
•Good practices for maintaining a validated state via configuration and change control
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
This affects the quality of software and increases the production cost of ... effectiveness of every method, it is useful to select the particular elicitation
http://www.imran.xyz
The presentation is design to provide answer to the very basic question "What is Business Analysis?", it is designed to guide the professionals who want to enter into BA profession or have started working as BA's.
In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation.
Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle.
There is now a new paradigm in process validation. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.
En un momento en que los presupuestos de IT están congelados o incluso en plena reducción, plantearse la utilización los procesos de Transición y de Gestión de Problemas para asegurar una reducción de los costes operativos es de vital importancia para facilitar la supervivencia de las compañías en la Post-Crisis
ERP Optimization: How to Save Cost And Gear Up For Business Innovation Simult...CAST
This slide presentation features Liz Herbert, Principal Analyst with Forrester Research Inc, on how to take control of your ERP system to enable growth and revenue generation by learning to:
-Find the balance between cost control and business innovation
-Manage the TCO of ERP systems by reducing complexity
-Identify performance and stability vulnerabilities by focusing on the quality of customizations
To watch the complete webinar, visit http://www.castsoftware.com/news-events/event/erp-customization-kills-innovation?gad=ss
Understanding the TCO and ROI of Apache Kafka & Confluentconfluent
For a product or service to be cost effective, it must be considered to be good value, where the benefits are worth at least what is paid for them. But how do we measure this, to prove the case? Given that value can be intangible, it can be hard to quantify and may have little relationship to cost. Added to this, the open source nature of Apache Kafka means that many companies skip the requirement to build a business case for it, until it has become mission critical and demands financial and human resources.
In this presentation, Lyndon Hedderly, Team Lead of Business Value Consulting at Confluent, will cover how Confluent works with customers to measure the business value of data streaming
Epicor ERP pricing is tailored to the unique requirements and scale of each business, making it difficult to provide a fixed estimate. Epicor offers a flexible pricing model based on factors such as the number of users, modules required, implementation scope, and ongoing support.
UCA - Skype for Business User Adoption reporting and monitoringCode Software
User Adoption is key to the successful delivery and on-going use of Skye for Business. UC Analytics delivers comprehensive reports, dashboards and monitors which will assist you in following the SOF (Skype Operations Framework) resulting in assured ROI in Skype for Business.
Maximo and a roadmap for your IoT journeyHelen Fisher
For IBM customers, the Internet of Things (IoT) enables businesses to improve operations, rapidly connect devices and to lower costs. This is why IBM Maximo Asset Management now sits neatly in the Watson IoT portfolio. There are many business cases out there today for linking IoT and Maximo, IBM are not, however, diverting from their core value statements. Maximo is still about understanding asset availability, preventing failures, maximising resources, increasing reliability, understanding inventory needs and costs, and plant safety. Check out the key investment areas for 2016 and beyond.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
This affects the quality of software and increases the production cost of ... effectiveness of every method, it is useful to select the particular elicitation
http://www.imran.xyz
The presentation is design to provide answer to the very basic question "What is Business Analysis?", it is designed to guide the professionals who want to enter into BA profession or have started working as BA's.
In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation.
Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle.
There is now a new paradigm in process validation. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.
En un momento en que los presupuestos de IT están congelados o incluso en plena reducción, plantearse la utilización los procesos de Transición y de Gestión de Problemas para asegurar una reducción de los costes operativos es de vital importancia para facilitar la supervivencia de las compañías en la Post-Crisis
ERP Optimization: How to Save Cost And Gear Up For Business Innovation Simult...CAST
This slide presentation features Liz Herbert, Principal Analyst with Forrester Research Inc, on how to take control of your ERP system to enable growth and revenue generation by learning to:
-Find the balance between cost control and business innovation
-Manage the TCO of ERP systems by reducing complexity
-Identify performance and stability vulnerabilities by focusing on the quality of customizations
To watch the complete webinar, visit http://www.castsoftware.com/news-events/event/erp-customization-kills-innovation?gad=ss
Understanding the TCO and ROI of Apache Kafka & Confluentconfluent
For a product or service to be cost effective, it must be considered to be good value, where the benefits are worth at least what is paid for them. But how do we measure this, to prove the case? Given that value can be intangible, it can be hard to quantify and may have little relationship to cost. Added to this, the open source nature of Apache Kafka means that many companies skip the requirement to build a business case for it, until it has become mission critical and demands financial and human resources.
In this presentation, Lyndon Hedderly, Team Lead of Business Value Consulting at Confluent, will cover how Confluent works with customers to measure the business value of data streaming
Epicor ERP pricing is tailored to the unique requirements and scale of each business, making it difficult to provide a fixed estimate. Epicor offers a flexible pricing model based on factors such as the number of users, modules required, implementation scope, and ongoing support.
UCA - Skype for Business User Adoption reporting and monitoringCode Software
User Adoption is key to the successful delivery and on-going use of Skye for Business. UC Analytics delivers comprehensive reports, dashboards and monitors which will assist you in following the SOF (Skype Operations Framework) resulting in assured ROI in Skype for Business.
Maximo and a roadmap for your IoT journeyHelen Fisher
For IBM customers, the Internet of Things (IoT) enables businesses to improve operations, rapidly connect devices and to lower costs. This is why IBM Maximo Asset Management now sits neatly in the Watson IoT portfolio. There are many business cases out there today for linking IoT and Maximo, IBM are not, however, diverting from their core value statements. Maximo is still about understanding asset availability, preventing failures, maximising resources, increasing reliability, understanding inventory needs and costs, and plant safety. Check out the key investment areas for 2016 and beyond.
IT Financial Intelligence - How the world’s largest companies are evolving th...Brad Swenson
Most enterprises understand the benefits that can be derived from increasing IT cost transparency, managing IT like a business, and improving the interaction between IT and business units. Yet, despite the inherent understanding behind these admirable goals, many IT financial management initiatives and implementation projects fail to live up to expectations
How to Improve Profit and Minimise Risks. Presentation by Raf Meersman, CEO, FiberPlanIT by Comsof at the Broadband World Forum conference 2015 in London
Cisco’s “Service Provider Transformation Framework” is taking a holistic view, across Technology and Operations, making transformation digestible (clear scope, phased approach, commercial/financing support). A target end state is proposed that will meet the sated business objectives. Subsequently, the end state is de-composed to into modular building blocks that can be assembled, given more granular SP priorities and current starting state.
2. Background Thispresentationprovidesyouwithbackgroundinformation on howtheplanningITsavingeffects will bereached. Itgivesyou an understanding on howplanningIThelpsyouwithreducingyour CAPEX, optimizingyour CAPEX andhowtheproductivityeffect will beconsidered in moredetail. NEEDS TO BE CUSTOMIZED FOR EACH CUSTOMER AND BE IN SYNC WITH THE EMAIL YOU ARE SENDING OUT
4. The opex / capexchallenge Year 1 Year 2 Year 3 Year 4...... Traditional IT Opex Traditional IT Opex Traditional IT Opex Traditional IT Opex 20% of capexbecomingopexnextyear Traditional IT Capex Traditional IT Capex Traditional IT Capex Traditional IT Capex 140.000.000 60.000.000 140.000.000 60.000.000 140.000.000 60.000.000 140.000.000 60.000.000 10% Stabilizing on a 70%/30% ratiorequires an annual Opexreductioncapability One time opex initiatives Continuousopexreductionapproaches Technology standardization Applicationrationalization Consolidationprograms Vendorsqueezing Ad hoc outsourcing Investment freezes (all having potential bounce back effects)
5. The plannigIT advantage a 10% opexreductioncapabilityisrequired to ensure a stableopex-capexratiobased on thedefinedscenario In year 1: € 4,50 M Over 10 years: € 90,83 M planningITenables a min. 13% continuousanualopexreduction !
6. Operational expenditures Exhaustion of the reduction potential Reduction measures process driven manually Technology standardization Standards management Technology lifecycle management Technology change management 48% traditional 78% planningIT continuous ad hoc Application rationalization Consolidation Decommission Lifecycle costing 31% traditional 83% planningIT comprehensive partial Road mapping Strategic road mapping Migration planning Scenario planning 17% traditional 91% planningIT business-oriented retrospective Service level alignment Demand management SLA readjustment 45% traditional 86% planningIT
7. The planningITadvantage – Improved Capexeffectivity 30% of all investments in IT don‘tdeliverthedesiredvalue In year 1: € 8,60 M Over 10 years: € 101,24 M planningIT savesannually min. 1/3 of all lost investments in IT projects !
8. ImprovedCapexEffectivity 30% of all investments in projects don’t deliver value ! Reasons: Project stops Bad projectmanagement Changedbusinessrequirements Redundancy in projects Architecturalprojectconflicts No adequatearchitecuralplanning Traditional capexoptimizationincl. PPM tools Contentfocussedarchitectural planning Use of planningITmakes 1/3 of lost investments in projectseffective
9. Capital expenditures exhaustion of the optimization potential optimization measures fragmented integrated Capability management Strategy alignment Demand management 27% traditional 85% planningIT process driven ad hoc Portfolio management Project definition governance Prioritization Project impact/redundancy analysis 64% traditional 91% planningIT reactive proactive Change management Project rework governance Project conflict governance Total quality management 17% traditional 72% planningIT
10. planningIT productivity effect PlanningITdelivers a productivityincreaseof 5,45 mendays per year telephoneinquiries Discussiongroups Application complianceinquiries Repositoryudates Data search & validation 800 applications x 2hours x 12 month = 10,91 man years x 50% = 5,45