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Oasis LIMS  |  CRISCON | CMS

 
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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