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QuTrack QMS - Vendor Qualification

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Vendor Qualification Scenario

The Quality & Safety of the products, from Life Sciences companies, are indirectly accountable upon the Vendor who supplied the raw material to the finished product. So the companies engage Vendor Management to manage prospective vendors, monitor recommended vendors and assess potential risks before appending a new vendor into the Approved Vendor List. But to bridge continuous communications with vendor, streamline effective process and fast track vendor qualifications especially when there are multiple proposed vendors, an automated solution can be the best approach.

Vendor Management Software Solution

Vendor Management System is web-based approach to automate the process of qualifying new vendors and manage approved vendors over a centralized platform connecting your organization with Vendors/ Suppliers. This Vendor Management Software enables fast-track collaboration with proposed vendors, simplify procurement, identify and manage supply chain issues such as non-conformances, shipment delays along with rating vendors based upon metrics to ensure best quality. The Vendor Management software gives real-time performance visibility for Management teams and clear transparency for the customers of your Organization.

The Vendor Management Software is designed to track and manage vendor associated CAPAs at CAPA Management and Vendor audits at Audit Management by integrating seamlessly and coordinating effectively.

With configurable workflows and flexible workflow components/ sections it is easy for the Vendor Management Software to be transitioned into your current vendor management process within in a short period. Comprehensive tracking and analysis 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 vendor and metrics reports bring high-level and in-depth performance visibility of the Vendor Qualification status or monitoring at any given point.

Besides providing best approach for an effective vendor management, the Vendor 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.

VeServ Vendor Management Advantage

Vendor Management software was developed based on extensive research on problems associated with customer and vendor with these core benefits:

  • Fully web-based solution with 24 × 7 Vendor Management System accessibility that allows managing vendors globally from anywhere
  • Cost effective in evaluating/ assessing vendors with metrics tracking and establishing closed-loop workflows with Vendors
  • Streamlined process ensures improved qualification timelines for new vendors and faster approval of changes in approved vendor and their raw material
  • Avoids an already approved vendor at one Site to be re-qualified at sister site with similar regulatory environment reducing re-work and benefitting on compliance costs
  • Helps recommending the best vendor by rating the vendors across a wide range of metrics such from pricing to vendor policies
  • Ease of reporting quality events such deviations, incidents at the Vendor Site
  • Improved Closure timelines with best practiced workflows
  • Live tracking and traceability of on-going issues with status, automated alerts and notifications
  • Capabilities to easily integrate and establish closed-looping with other Quality Systems such as CAPA
  • 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 and an effective Vendor Management Software, the system has several key features that enable organization and vendors to continuously improve quality standards

Key Features

Simplified Proposal

By being a web based platform the proposal of new vendors for qualification is made easy with sections that capture complete vendor information through organized sections, auto selections and limited manual entry. And with automated routing, the proposed vendors can be taken up for assessment without any delays as compared to manual system.

Robust Vendor Assessment

The vendors are assessed through series of tasks that establish workflows between the organization and the vendors and enable live tracking. For example consider the task of completing the vendor questionnaire, assigned to multiple vendors and tracked simultaneously for closure with due dates.

Integrated Audit Management

The Vendor Management Software is designed to fully integrate with Audit Management to manage vendor audits after vendor assessment. The associated findings, investigations at the vendor site and closure are coordinated at Audit Management.

Integrated CAPA Management

The Vendor Management system is designed to track associated CAPA that originate from vendor audit findings in real-time as they are progressed at the vendor. This establishes a seamless traceability check across all proposed vendors and results in improved timelines in recommending vendors for trial supply evaluation.

Real-time Issue Tracking

With traceability made available at the click of a button, any on-going issues can be identified, responded immediately and tracked for faster closure.

Quality Metrics

By providing the tools to analyze vendors with quality metrics across a wide range allows an organization to prevent potential risk associated vendors to be identified at early stages before procurement of trial supply material.

Ratings

The system allows multiple vendors to be compared and scored based upon their quality metrics and many other criteria such as pricing. This ensures that vendors are selected and recommended for their reliability, track record and performance.

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.

Auto Spell

Entered information needs to be described in detail and spelled correctly. The in-built spell check feature ensures all CAPA related information entered into the system is spelled correctly. By auto suggesting and auto correcting with good user interface, users can quickly complete data entry which helps in avoiding repetitions and reduces time spent.

Audit Trails & E-signatures

The trail of the record is tracked and time-stamped providing details of actions performed, at the workflow steps giving in-depth traceability about who performed the action and at what time. Also the system features capturing of the user-consent to the action performed by entering a highly secured and high-level password i.e. e-signature.

Easy to analyze Reports

Summary Reports that provide real-time summary without opening the record helps personnel holding critical positions to save time by viewing the entire information in one go. Generation of reports on the status of the records enables high visibility of the Vendor Management System and Vendors. With eye catching graphical representation the reports are informative and impressive.

You can feel free to reach us to know more about VeServ Vendor Qualification System and get your questions answered.

Industries that can benefit from our Solution

  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages