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Val Genesis
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Val Genesis -Validation Software Solution for Bio, Pharma, Laboratories, Contract Organization and Medical Device Industry
Val Genesis -Validation Software Solution for Bio, Pharma, Laboratories, Contract Organization and Medical Device Industry

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Free Webinar:  March 2015 | April 2015 : Electronic Paperless Validation Lifecycle Management Process

This session will demonstrate how an electronic Validation Life cycle Management System will:

1) Facilitate a paperless validation process without changing the current business process

 2) Standardize and improve the efficiency of your current validation process with use of templates and workflows

3) Reduce overall validation cycle time by 30%-50%

4) Enforce consistency and enhance compliance in all types of validation process

 5) Harmonize and Globalize the validation process

6) Significantly reduce the cost of validation

7) Eliminate the inefficiencies that plague manual validation process

 8) Enforce validation policies and procedures that are typically buried in paper documents

9) Mitigate or avoid the commonly cited validation issues (in FDA's warning and 483s)

10 ) A 21CFR Part11 compliant system that will help your organization breeze through any audit

Register now by clicking a link below:

Tue March 17, 2015 – 9:00 AM – 10:15 AM PST
Tue March 24, 2015 – 9:00 AM – 10:15 AM PST
Tue March 31, 2015 – 9:00 AM – 10:15 AM PST
Tue April 7, 2015 – 9:00 AM – 10:15 AM PST
Tue April 14, 2015 – 9:00 AM – 10:15 AM PST

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ValGenesis (Electronic Validation Software ) - Varian Medical Systems Implements ValGenesis Cloud Solution

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Maintaining the Validated status of GAMP 5 – Cat 4 and 5 applications such as SAP.

     Changes are inevitable and unavoidable for growing companies to meet the continuous changes in the process and user requirements. Validated Enterprise software applications including SAP and Oracle need to accommodate these continuous changes and also maintain the validated status.

         Any changes to the validated system will require validation of the specific change and regression testing (as required). Since the requirements, design specification, test cases etc. are associated, any change to one specific requirement will impact all the other associated documents and requires to update all the associated documents. This process will increase the validation effort significantly, companies either have to have large validation team or avoid all these change to maintain the validated status of the Enterprise Software applications. 

        ValGenesis has introduced a lean validation process to reduce the validation effort by 50-70% by generating a consolidated executable Validation Summary and mitigate the impact associated with all the documents. There are few complimentary Webinars scheduled to demonstrate this process. 

To register,
http://valgenesis.com/index.php?option=com_content&view=category&layout=blog&id=66&Itemid=243  

Maintaining the Validated status of GAMP 5 – Cat 4 and 5 applications such as SAP.

     Changes are inevitable and unavoidable for growing companies to meet the continuous changes in the process and user requirements. Validated Enterprise software applications including SAP and Oracle need to accommodate these continuous changes and also maintain the validated status.

         Any changes to the validated system will require validation of the specific change and regression testing (as required). Since the requirements, design specification, test cases etc. are associated, any change to one specific requirement will impact all the other associated documents and requires to update all the associated documents. This process will increase the validation effort significantly, companies either have to have large validation team or avoid all these change to maintain the validated status of the Enterprise Software applications. 

        ValGenesis has introduced a lean validation process to reduce the validation effort by 50-70% by generating a consolidated executable Validation Summary and mitigate the impact associated with all the documents. There are few complimentary Webinars scheduled to demonstrate this process. 

To register,
http://valgenesis.com/index.php?option=com_content&view=category&layout=blog&id=66&Itemid=243  

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Webinar Sep, Oct & Nov 2014.: Paperless Validation Life cycle Management Process. 

The Session will be focused on how an Electronic Validation Lifecycle Management System (VLMS) can standardize and improve the efficiency of your current validation process for software, instruments, equipment, methods and processes. During the webinar, we can demonstrate how our global regulated manufacturing clients are experiencing a reduction in their validation cycle time and validation costs by 30%-50%. 
This session will demonstrate how an electronic Validation Lifecycle Management System will:
•  Facilitate a paperless validation process without changing the current business process
•  Standardize and improve the efficiency of your current validation process with use of templates and workflows
•  Reduce overall validation cycle time by 30%-50%
•  Enforce consistency and enhance compliance in all types of validation process
•  Harmonize and Globalize the validation process
• Significantly reduce the cost of validation
•  Eliminate the inefficiencies that plague manual validation process
•  Enforce validation policies and procedures that are typically buried in paper documents
•  Mitigate or avoid the commonly cited validation issues (in FDA’s warning and 483s)
•  A 21CFR Part11 compliant system that will help your organization breeze through any audit
Select the Date to Register: 
https://www3.gotomeeting.com/register/244988678 Tue, Sep 23,2014 8:30 AM - 9:45 AM PDT  https://www3.gotomeeting.com/register/252509222 Tue, Oct 21,2014 8:30 AM - 9:45 AM PDT  https://www3.gotomeeting.com/register/246327710 Tue, Sep 30,2014 8:30 AM - 9:45 AM PDT  https://www3.gotomeeting.com/register/253964222 Tue, Oct 28,2014 8:30 AM - 9:45 AM PDT   https://www3.gotomeeting.com/register/249089294 Tue, Oct 7, 20148:30 AM - 9:45 AM PDT  https://www3.gotomeeting.com/register/255762166 Tue, Nov 4, 20148:30 AM - 9:45 AM PST https://www3.gotomeeting.com/register/251956030 Tue, Oct 14,2014 8:30 AM - 9:45 AM PDT  https://www3.gotomeeting.com/register/256905534 Tue, Nov 11,2014 8:30 AM - 9:45 AM PST

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Webinar  Sep, Oct, No 2014:Electronic Log Manager to manage Cleaning & Usage Logs. Sep, Oct &Nov 2014

The Session will be focused on how an Electronic Log Manager enforces efficiency, consistency and compliance in the Cleaning and Usage Log management in GMP environments. During the webinar, we can demonstrate how our global   regulated manufacturing clients have eliminated the need for paper log books and streamlined their entire process of entering, verifying and reviewing the cleaning and usage log requirements.
The following topics will be discussed during the Webinar
• Regulatory requirements for cleaning and usage logs
• Capture, Verify and Review log entries with required electronic signature from anywhere in real time through Tablet or Laptops or Desktops
• How Log Manager Provides 360 degree visibility for the cleaning and usage logs
• How ValGenesis manages the Lifecycle of GxP assets from Qualification, Change request, Revalidation, Cleaning, Usage and to Retirement
• Eliminate the inefficiencies that plague paper based cleaning and usage log management
• Enforce policies and procedures in cleaning and usage log management process that are typically buried in paper documents
• Enforce consistency and enhance compliance in the Cleaning and Usage Log Management process

Register to participate by clicking a below link: 

https://www3.gotomeeting.com/register/352939998 Wed, Sep 24,2014 8:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/356365870 Wed, Oct 22,2014 8:30 AM - 9:45 AM PDT    

https://www3.gotomeeting.com/register/353691910 Wed, Oct 1, 20148:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/356945838 Wed, Oct 29,2014 8:30 AM - 9:45 AM PDT    

https://www3.gotomeeting.com/register/355100262 Wed, Oct 8, 20148:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/357636638 Wed, Nov 5, 20148:30 AM - 9:45 AM PST    

https://www3.gotomeeting.com/register/355813078 Wed, Oct 15,2014 8:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/360783550 Wed, Nov 12,2014 8:30 AM - 9:45 AM PST 

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Webinar  Sep, Oct, No 2014: Maintain the Validated status of your GxP software systems through Closed loop with Change Management – SAP as  an example : 

      The session will be focused on how ValGenesis system reduces the validation and change management efforts by over 50% though the innovative closed-loop change management process. During the webinar, SAP system will be used as a case to demonstrate, how this unique process enforces consistency, enhances efficiency, reduces the effort and maintains the validated status throughout the life-cycle of the SAP systems 

The following topics will be discussed during the Webinar

• Pain points in managing the validated status of GAMP 5 Cat 4 and 5 GxP software systems
• How ValGenesis creates dynamic trace between the requirements and test cases
• How the selection of one or more requirements identifies all the impacted other requirements and test cases across the system
• How ValGenesis brings all the impacted artifacts into a single Change Control Validation Summary
• Electronically execute the Change Control Validation Summary and manage the deviations
• Approve Change control validation summary and inherit the approval to all the impacted deliverables to maintain the validated status with minimal effort
• How ValGenesis reduces the effort by 50%in maintaining the validated status of Cat 4 and 5 GxP software systems
• How ValGenesis provides 360 degree visibility for the validated GxP software systems across the sites
• How ValGenesis eliminate the inefficiencies that plague paper based
• Enforce consistency, policies and procedure while enhancing compliance in the software validation process

Select the Date to Register 

https://www3.gotomeeting.com/register/389323974 Thu, Sep 25,2014 8:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/403939078 Thu, Oct 23,2014 8:30 AM - 9:45 AM PDT    

https://www3.gotomeeting.com/register/396727558 Thu, Oct 2, 20148:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/406533734 Thu, Oct 30,2014 8:30 AM - 9:45 AM PDT    

https://www3.gotomeeting.com/register/398027318 Thu, Oct 9, 20148:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/408927534 Thu, Nov 6, 20148:30 AM - 9:45 AM PST    

https://www3.gotomeeting.com/register/400386486 Thu, Oct 16,2014 8:30 AM - 9:45 AM PDT   

https://www3.gotomeeting.com/register/412793854 Thu, Nov 13,2014 8:30 AM - 9:45 AM PST

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ValGenesis Case Study with ScinoPharm         

" Getting a new facility up and running required extensive development, review,revision, and approval of validation documentation. We wanted to avoid mounds of paper and minimize
signoff time, but we saw a lack of functionality related to the validation process offered by traditional document management systems. We found what we needed in ValGenesis.”

— Steve Johnson, Director, Operations
Injectable Facility
ScinoPharm Taiwan, Ltd.  

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ValGenesis Case Study with Global Pharmaceutical Company

“ValGenesis spares us the walking around and mailing time by providing simultaneous access to multiple reviewers and approvers at different sites. This solution eliminates paper, duplication, and waiting. But its greatest value is in helping us communicate effectively.”


Validation Manager
QU Validation and Validation Systems
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