Vendor Qualification

Vendor Qualification Management and Tracking

To stay compliant with local and international regulations such as the US FDA, EU, and MHRA, etc, the pharmaceutical companies need to restructure their approach to Vendor Qualification. While working with a large number of suppliers and third parties around the world with a large base of specialized products, Procurement Company requires a scalable model for assessing the working practices of suppliers and third parties. Most of the Pharmaceutical Manufacturing Companies will deal with several suppliers or third parties for the supply of different materials for multiple departments (Production, Warehouse, Laboratory, Stability, etc.).  

Challenges in Vendor Qualification in Pharmaceutical Industry

A company must procure raw materials to produce a tablet. Therefore, different raw materials and active ingredients are required to produce a final product.
The process of vendor qualification procedure involves following sequential steps for acquiring : 

  1. Analyzing Requirements
  2. Vendor Selection
  3. Request for Proposal (RFP)
  4. Evaluation
  5. Selection and Negotiation
  • Lack of internal procedure and guidelines for conducting Vendor Management. Currently, there is no software or tools to support their qualification functions. Due to more time consuming, they are unable to produce accurate vendor risk reports.
  • There is no standard template for RFP (Request for Proposal), every time preparing an RFP will consume a lot of time to complete and hence it leads to delay in their Selection Process.
  • Continuous monitoring and keeping track of activities of them, documentation is difficult while doing it manually when the list and number of suppliers are high.
  • Lack of Communication, feedback, and inputs from them makes the regular enhancements slow.
  • Unable to evaluate their performance due to lack of visibility

Tracking these issues by using the paper-based or excel spreadsheets can become a time consuming and prone to errors. To meet these requirements AmpleLogic developed an automated Vendor Qualification Management Solution which can simplify in identifying supplier quality issues.

Pharmaceutical Vendor Qualification Solution enables organizations to maintain a vendor management system that gives them complete control and visibility of records and documents related to each supplier

Features of AmpleLogic Vendor Management Software

Simplified Proposal

Being a web-based platform the proposal of new suppliers for qualification is easy with sections that capture complete their information through an organized section, 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 a manual process.

Robust Vendor Assessment

They are assessed through a series of tasks that establish workflows between the organization and their enable live tracking. For example, consider preparing the Vendor Questionnaire, assigned to multiple suppliers and tracked simultaneously for closure with due dates.

Integrated Audit Management

The Vendor Management Solution is designed to integrate with Audit Management to manage their audits after assessment purpose. The associated finding or investigations at their site and its closure are coordinated at Audit Management.

Integrated CAPA Management

The Vendor Qualification System is designed to track associated CAPA that originate from Vendor Audit Findings in real-time as they progressed. This will establish seamless traceability checks across all proposes and results in improved timelines in recommending them for trial supply evaluation.

Real-time Issue Tracking

With traceability, 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 with quality metrics across a wide range allows an organization to prevent potential risk with associated vendors to be identified at early stages before procurement of trial supply material.


The Vendor Management System allows multiple suppliers can be compared and scored based upon their quality metrics and other criteria such as pricing. This ensures they are evaluated or selected and recommended for their reliability, track record and performance by using the Vendor Qualification.

Automated Alerts & Notifications

This is a practical feature that ensures the users are automatically communicated at defined frequencies and at defined workflow steps regarding 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 will also auto escalates the overdue to the concerned authority and thus helps to resolve the issue.

Critical Advantages of Vendor Management System Software
  •  Vendor Management Streamlined Organizations can concentrate on their core business when Vendor Qualification is streamlined with automation.
  • Vendor Registration can be done in two ways either with a new or existing one. If organizations go for a new supplier, the system automatically opens. If the OTP is for an existing one, the system will open the Approved Supplier Lists
  • Whenever sample evaluation is done, the system will assign a Provisional Vendor Allotment Number (Temporary Registration) which then converts to Approved List after successful evaluation of the trial sample.
  • The Vendor List Ratings will help organizations to have a note of a list of qualified suppliers who are streamlined over the period of several transactions.
  • With a Vendor Management Solution, organizations will have access to a centralized repository for vendor information, contracts, financials, security policies, insurance certificates and other sensitive data which they need to understand of organizations. This information can be collected, stored, and used in a meaningful way at one place which simplifies the process of managing multiple relationships to increase efficiency, reduce time, and cut costs associated with Vendor Qualification Management.
  • Vendor Analysis and Assessment can be done based on complete data available in the repository.
  • The system generates Agreement Completion Reports so that organizations can track the renewals.
  • The Vendor Performance With metrics such as Vendor Quality Score, Sample Evaluation Quality Score, Quality Score Average organizations can increase the performance of the suppliers
  • Managing all the transition from one party to another, which can often result in a break of supplies and loss of income.
  • Different stages such as Cancelled, Approved and Discontinued of Vendor Qualification Procedure can be traced.
  • Able to generate additional metrics like top 10 Vendors score, top 10 raw materials score, etc.
  • With automated processes and alert notifications, timely response to a vendor’s query goes a long way to ensure efficiency and stability. Thus, enabling companies to form long-lasting partnerships with your suppliers that has numerous benefits.
  • The system generates customized reports, form reports and Approved/ Rejected List and Graphical reports for reference