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Change Control/Deviation Management - Enterprise tool
Oasis provides an enterprise tool to electronically control Change
Management System for initiating, creating, reviewing, commenting,
signing off and evaluating the changes pertaining to SOPs / STPs /
Product specifications / Procedures etc. for subsequent approval or
rejection, with complete process of change implementation, finally.
The system maintains complete audit trail of change request that
documents sequenced transmissions, development and modifications
suggested by officials of various departments, for its submission and
closure. It can efficiently handle all intra or inter department change
requests and procedures.
It can also be integrated seamlessly with enterprise applications
such as
LIMS (Laboratory Information Management System) and also enables
User Company to organize and manage unstructured contents in a proper
manner, under secured environment.
Change Control Proposal
Provision is there to initiate proposals for change, by any user,
from any department / section of a plant.
A unique ID (CCP No.) is generated automatically on location basis or
as per client’s specific requirements.

There is a provision for selecting category of change (i.e. nature of
change) such as SOPs,
Method of analysis, BMRs, Specifications (Process / Document /
Procedure etc.).
The system allows you to define related product code, description and
batch number along with detailed description of the proposed change and
its justification.
It is possible to link or attach documents from different
applications (as enclosures) for on-line reference to reviewers.
· Microsoft Office (ascii, word, excel,
html)
· Adobe Acrobat (pdf)
· Scanned documents
User defined Evaluation Parameters
There is a provision to incorporate user-defined parameters to
record evaluation and comments on change subject, transmitted to the
concerned user for inter dependent tasks (such as review or approval).
These parameters can be selected on-line, to meaningfully address the
comments and remarks at the time of filling feedback forms, as an
important activity of change proposal submission.
Forward Request
The proposal may be forwarded across departments from a
user-friendly interface for its subsequent acceptance in order to
implement the change. The details such as date of action, comments, and
suggestions can be entered or request can be transmitted further, for
following actions by concerned users (there is provision to multicast
change request for evaluation, for their feedback).
· Review
· Evaluation
· Approval
Change Request Decision
Request for approval may be made in either case
· Minor (small)
· Or major (critical) category
at unit / department head or corporate level. This is followed by
detailed summary report for its subsequent closure. The closure summary
also incorporates action to be taken, responsibility and target date
of completion for implementation of change request.
Provision is also there to reject the change request by providing
adequate reason.
Collaborative Viewer for complete trace-ability

Collaborative administrative tool is provided to trace logs and audit
trail of complete life cycle of the change request passing through
various stages of approvals. The audit trail gives complete history of
related events with reasons/remarks stated by concerned users.
Users can get chain forward request in a group, with a rigorous
security control and in a restricted access manner.
Reports
Various reports are available at service level and MIS level to guide
user to take correct action and decision quickly.
Pending proposals
· Pending for review
· Pending for evaluation
· Pending for approval
Proposals completed
· Accepted Proposal
· Rejected Proposals
· Detailed proposal report
Alerts
/ Reminders
Provides excellent messaging tools for its users for message alerts
from the system, to inform user about the tasks assigned.
Whenever a new task (such as review, approval, evaluation) is
directed to a user, the system issues a message alert to the concerned
user. This triggers on the event of registering/logging with the system,
after giving individuals correct identification and password.
The message pops up in home window automatically, giving users
instructions for pending and the due tasks assigned.
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