Caliber DMS

Caliber DMS ( Document Management System compliant with 21 CFR part 11)

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21CFR part 11 compliant Document Management system

CaliberDMS ,designed as per regulatory norms followed by pharmaceutical industry, will help you to manage large volumes of documents with authorization control so that no validated document can be modified unless it is formally revised. one of the most important need is to ensure only the latest version of the document is in circulation and all obsolete documents are not in use, CaliberDMS version management will make this possible for you.

The complete life cycle of the document as regulatory norms can be managed in the CaliberDMS ( Document management system)

  • online document creation process ( the initiation process)
  • Review and approval process
  • controlled issuance
  • Obsolete versions
  • Auto distribution to the respective department

Caliber DMS is web based application, you have nothing to install on the users workstations a internet browser is enough. It follows GAMP5 guidelines for implementation and a 15 day training to the team will make them use it.

The Benefits  From Deployment Of CaliberDMS Include

CaliberDMS  ( Document Management System) which is specially designed for pharma manufacturing  comes with features
and dynamic integration possibilities with other enterprise applications to manage the cGMP compliance, configurable
eforms that add great value to Quality assurance processes and automating
workflow related processes.CaliberDMS helps you create a single centralized repository of all your
electronic documentation and features such as,version control, access control and audit trail makes it the perfect system
for regulatory document management.

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The Benefits  From Deployment Of CaliberDMS Include

Online document creation

  • Online document creation with track changes, commenting
  • Tracked collaborative working
  • Multiple document lifecycle statuses
  • Timed lifecycle movement of documents
  • Congfigurable approval rule
  • Creation of reusable Header Footer Templates
  • Optional Word or HTML based document Editor
  • Harmonize your documentation process
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Document Publishing

  • Publish documents in PDF or Word
  • Publish created document to a category
  • Publish external document to a Category
  • Organize documents
  • Publish documents directly from External applications

Features you will like to have

  • Automated Routing, Escalation ( to reduce document cycle time by automating routing & escalation for overdue tasks)
    Automation routing streamlining processes.
  • Auto-load Feature
    • Existing controlled documents can be imported ( bulk import) with approval process
    • Configurable sequence number
    • Lockout feature for uploads for online creation of documents
  • Auto distribution to ensure the timely distribution without additional approvals
CaliberDMS
CaliberDMS

Authorization & Access control

  • Configurable document access controls
  • Access policy setting for single or group of docs
  • View permissions through HTML
  • Document Print controls
  • Document Edit controls

Alerts & Intimations

  • Configurable Event based alerts
  • Critical Documents access alerts
    • Opened by
    • Printed by
    • Duration
  • Review- due alerts
  • Pending action reminders
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Integration with Quality Systems and Training

  • Seamlessly connected with other quality processes like QAMS ( Quality assurance management system)
  • Ensuring complete compliance and Continuous improvement
  • Quality system always ready for inspections and audits.
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