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ValGenesis - Top 10 Reasons
ValGenesis - Top 10 Reasons
Implement ValGenesis
Significant Functions and
Features of ValGenesis
Overview .......................................................................................................................................3
Conclusion.................................................................................................................................. 12
Overview
Top Ten Reasons That ValGenesis Ensures Success!
Making a Strong Impact on the Corporate Validation Process
It has been said that without change there is no progress nor are there incentives for improvement. For that reason, change is
a necessary component in the business world as it generally inspires greater efficiency and more advanced business ideas.
Validation has been an essential part of FDA-regulated industries for over 20 years, yet as the field has evolved, little has
changed about the business process of validation. 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. By and large, predominantly paper
and manual based validation processes stifle innovation, cause compliance risk and compromise a life science firm’s ability
to bring products to the market on time. Plus, with the increased use of computers along with the progression of evolving
software technology, a more advanced validation solution has become essential to the life sciences industry.
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Benefit 1: Track the Validation Status in Real Time
In the current paper-based validation process, tracking validation status of any system, equipment or instrument is time
consuming and very often submerged in a sea of paper.
Overall, validation managers and supervisors spend an inordinate amount of time searching out both validation status and
documents during the process. ValGenesis is designed to provide real time, corporate wide validation status in just a few
mouse clicks, providing a holistic view of a company’s validation status and easily identifying bottlenecks, which expedite
the validation process. To ensure its efficiency, ValGenesis offers three intuitive ways of tracking the real time valida-
tion status of any entity (system, instrument, equipment etc.) corporate wide.
ValGenesis is designed with a drill down Inventory Report Manager that allows for the tracking of the validation status on any
entity that is registered in the system. The Inventory Report Manager stores entities in a user-friendly tree hierarchy for sim-
plified navigation. Similar entities can be grouped into sub categories, while similar sub categories can be grouped under one
category. ValGenesis does not restrict the number of categories, sub categories or entities. Below, in Figure 1 is an example
of the Inventory Report Manager.
As demonstrated, the Inventory Report Manager saves a significant amount of time that would otherwise be spent tracking the valida-
tion status of an entity. In ValGenesis, an entity can be located in just a few mouse clicks complete with details outlining the validation
status along with User ID and Time Stamps captured for each associated activity, including development, execution review, approval
etc. Figure 2, found below is an example of the Meta data associated with the development and execution of a validation document
that is generated by ValGenesis and viewed through the Inventory Report Manager.
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Fig. 2: Validation Document Report
ValGenesis also provides a dashboard that furnishes instant access to the validation status of any validation document currently in
the development or execution phase of the validation life cycle including documents awaiting assignment, under process, or pending
approval. Upon logging into ValGenesis, as shown in Fig.3, users with an appropriate role can view the validation document status
of any entity regis¬tered in the system in real time. The dashboard feature is designed with pie charts with each pie chart subdivided
into sections that provide a more granular look at either the development or execution stages.
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• Tracking Validation Status with Barcode
Another important tracking feature built into ValGenesis is the barcode feature that allows for the generating of unique bar
codes for each entity registered in the system. The bar code feature is a tremendous aide for a number of reasons. As the bar
codes are printable, they can be physically attached to the entity and used for identifying validation details of an entity simply
by scanning. When scanning an entity on the production floor, users can determine the real time validation status of the entity
during an audit. This significantly reduces the time currently spent on retrieving documents from a document repository and
provides assurance to withstand scrutiny by any internal, FDA or other external audits. In short, a tremendous amount of time
is saved through the bar code feature as it allows entity specific validation information in real time on the production floor.
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has confirmed review of the document, the developer is able to assess all comments, making any required changes before
routing the document for approval.
The approval workflow in ValGenesis also eliminates delays caused by lost or misplaced validation documents. Since the
approval is completed electronically, the possibility of losing or misplacing a document is eliminated entirely. Each time an
approval task awaits a response from the designated approver, a message is sent through the Task Alert Feature as well as the
corporate email system ensuring that the approver is notified immediately of the approval task. Electronic signatures available
with ValGenesis can be configured to follow the corporate specific chain of custody requirements and to enforce validation
procedures and requirements.
In addition, during the execution, the Witness function gives users the ability to ‘witness’ during the validation execution and
can be enforced based on qualification requirements. Because the witness functionality is built into the ValGenesis system,
it closely follows a paper-based process and allows for a second user to sign off, verifying the execution. The ability to adapt
the witness requirement is completely configurable by the ValGenesis system administrator at the protocol level and can be
adapted for specific GxP entities and/or qualifications.
Benefit 6: Great Audit Trail Tool for Internal and FDA Audits
ValGenesis has several built in features designed to meet FDA compliance requirements that withstand audit inspections.
These features include audit trails for documents, administrator audit trails for changes, security settings and user access
permissions, compliant electronic signatures with date and time stamps, and a secure database to store documents and other
validation related information. The audit trails for approved and executed documents in ValGenesis are designed to display a
report of the various steps during document completion with associated electronic signatures, date and time stamps. Based
on the corporate wide real time validation tracking, ValGenesis reduces the audit duration from a few days to a few hours.
With ValGenesis, complex revalidation schedules are managed by the application. The revalidation scheduler module is de-
signed to alert user groups of any upcoming or delayed revalidation tasks ensuring that critical GxP entities are revalidated on
time. Once a revalidation schedule has been defined and approved, the schedule is automatically written to the revalidation
schedule calendar and user groups are automatically alerted of any upcoming or delayed revalidation tasks through email
Revalidation scheduler in ValGenesis improves the lines of communication between the various departments through a con-
figurable approval workflow and the revalidation schedule calendar. Approval of revalidation schedules with different groups
helps to minimize the impact of the revalidation schedules on other regular activities including production.
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Benefit 8: Availability of Electronic Validation Data and Documents
ValGenesis is built on an open architecture to easily integrate with other quality systems including change management,
deviation, ERP and document management systems so as to have effective bi-directional data flow. In a paper-based process,
document security is often challenged and quality often compromised. As a result, developed and executed documents can
be misplaced or lost during the review and approval process. The nature of paper data ties it to one physical location, and
distributing copies of data can be hard to track and secure.
FDA encourages companies to move into an electronic system so as to improve the process and to enforce the consistency and
quality. Because ValGenesis provides end-to-end validation automation, from validation document number generation all the
way to execution and deviation management, it turns the validation process into a 100% paperless and electronic system. The
developed and executed documents are available with Meta data appended in the PDF format with 128-bit encryption.
The Good Automated Manufacturing Practice Guide (GAMP), for testing of GxP systems states, “Computerized test manage-
ment tools can significantly reduce the amount of paper used during testing and can provide helpful test management sup-
port. This includes the ability to report on the status of test activities and facilitate test activities by the use of work-
flow. In most large testing projects, the use of such a tool can reduce testing time scales.” Implementing ValGenesis
validation management system offers significant value, as it is easy to locate, plus different users with different roles
in different locations can be given secure and non-exclusive access with complete audit trail and traceability.
ValGenesis can be configured to enforce the consistency in the validation documentation through templates. As engineers
and consultants are compelled to use the preconfigured template for specific validation document types, ValGenesis takes
care of populating the entity information including model numbers, version numbers, etc., from the database as configured.
Document review and approval workflows follow the Good Document Practice (GDP). The revalidation schedule module with
revalidation calendar and task alert feature eliminates the possibility of missing the revalidation task of GxP entity. During
the execution, user ID and time stamps are captured at each row and screen shots on any supporting documents can be added
at each row to quantify the execution, thereby meeting the stringent compliance requirements. Spelling mistakes and typos
are also captured and can be corrected along with a reason for the change with User ID and time stamp. All deviations are
handled through controlled workflows. The developed and executed documents are available in the electronic format with
read only access and with print controls. In brief, ValGenesis can be configured to impose compliance and consistency in the
corporate validation process.
• Real time Validation Status: Eliminates the time requirement to track the validation status
and documents
• Time bound Review and Approvals: Enforced time limits for the review and approval tasks.
• Web Access for Validation Tasks: Documents can be reviewed and approved virtually
from anywhere.
• Electronic Storage: Electronic Storage removes the storage document space requirement.
As an out-of-the-box solution, ValGenesis requires less overall implementation and validation time, and allows the infor-
mation technology and validation experts within an organization to manage other projects simultaneously. By combining
pre-configured ValGenesis application software with user requirements, templates and rapid implementation methodology,
implementation of ValGenesis can be achieved in a very short period of time. The rapid implementation methodology not only
provides faster service but it also affords a quicker return on investment (ROI), lesser total costs of ownership (TCO) for clients
as well as gaining a critical competitive advantage.
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In Conclusion
As an intuitive, user-friendly application, ValGenesis is most assuredly a tool that can be configured
to enforce any specific business rules that meet and comply with the validation process. Though many
life science organizations are cautious about implementing automation technologies in FDA-regulated
environments, many others are discovering that these tools actually help to reduce compliance uncer-
tainty as well as decreasing cost of validation. As validation has become very important to the success
and survival of companies, automation has proven to greatly streamline operations. In effect, properly
deployed automation technology actually lowers compliance risk, thereby making the validation pro-
cess far more efficient. Once configured, very little training is required, therefore companies can quickly
benefit from the advantages offered by ValGenesis and immediately begin realizing a significant ROI.
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