In Pharmaceutical companies Each and every activity within a GMP regulated environment is based upon controlled documents and revision control. Therefore Document Control, Management and Issuance is core to the functioning of the Life Sciences companies and exhibiting Compliance and Quality. The manual paper based document management and control systems are dependent on the interests of an individual for document turn around and are often characterized with poor traceability, space constraints, highly repetitive, improper communication and many more to term. These inadequacies are being realized slowly which in turn increases the need for an automated and Electronic Document Management Software for Life Sciences companies.
Pharmaceutical SOP Documents and Template Issuance
Request based issuance of the documents based on the Request. End user’s can raise the request for SOP, Process templates, Analytical Sheets and Checklists Can be Requested online. Based on the Approval process Unique Issuance No will generated and the same will be printed on the Delivered document.
Document Control and Management
This Document Management, Issuance and Tracking Software manages the Pharmaceutical controlled documents across the Organization on a centralized repository. The Document Management System enables an Organization to electronically request document changes, route changes for approval, implement revisions and make revised document effective after completion of Trainings at the integrated Trainings Management System.
With configurable workflows and flexible workflow components/ sections it is easy for the Pharmaceutical Document Management software to be transitioned into your current document control process within in a short period. Powerful data analytics and graphical representation is made available at the click of a button with Summary Reports and Metrics Reports. Summary Report gives real-time summarized information within the selected document and metrics reports bring high-level and in-depth performance visibility of document control and management across the organization at any given point.
Besides providing best approach for effective management and revision control of document changes, the Drug maker’s Document Management Software is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.
Document Issuance and Tracking Software Advantages
This Electronic Document Management and control system was developed based on extensive research of guidelines from various regulatory agencies and yet be practical and problem oriented with these core benefits:
- Enterprise wide 24 × 7 accessibility to request document changes and control master documents
- Total compliance with 21 CFR part 11
- Centralized SOP documents, templates and Checklists repository for organized archiving and being easily accessible
- Role based access controls over the document types such as Corporate Documents to Corporate QA, Raw Material Specifications to QA & Warehouse
- Diversified solution to manage complex document changes such as Facility Modification
- Revision Control and ease of access to previous revisions bringing traceability
- Live tracking and traceability of documents under revision with status, automated alerts and notifications
- Capabilities to easily integrate and establish closed-looping with other Quality Systems such as Trainings
- Customizable workflows to suit your current process
- Metrics Reports or Trends that are exclusively analytical and visually eye catching
Apart from being an industry standard solution, the system has several key features that enable control of documents effectively.
Pharmaceutical Document Issuance and Management software Key Features
Simplified Document Requests
The document change request can be initiated through simple change request section that reduces the manual entry with auto selections. These easy to define are carefully provided to capture all document related information irrespective of any type of document change.
Automated Routing and Approval
Manual Document Management System in Pharma companies end up taking a lot of time sitting across desks unnoticed until the issue escalates. But with pre-defined responsibility and roles, the document is routed to responsible individuals based upon the document type and departments initiated. The review is made simple with comments and clarified activities.
Sequential and Parallel Reviews
In order to achieve faster document turn-around timelines the documents can be routed in a parallel manner that allows multiple reviews.
In situations where there is a disagreement of changes requested across departments or individuals the document can be returned with comments and re-routed with updated changes if any.
This is needy feature that shows the versions of a document right from document change initiation to approval of final version. This establishes a clear transparency across multiple versions of a document from draft to approve.
Integration with Word processors
This feature allows capabilities to handle changes from multiple users over a single document. By integrating the Word documents into the system and allowing Check-in and Check-out facility, the document allows access as per permissions and avoids multiple users working on the document at the same time.
Integrated Quality Systems
The Document Management system is designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow between document management and rest of the quality systems specially Pharma Training software. The SOP Trainings originating can be initiated and closed at the Trainings Management System with enabled status tracking at the Document Management System.
Automated Alerts & Notifications
This is practical feature that ensures that the users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue to the concerned authority and help resolve the issue.