Vendor Qualification Management
One of the standards set by international regulatory bodies such as the FDA, MHRA, EU Annex 11, etc. is ensuring that pharmaceutical and life sciences develop and design an Effective Vendor Qualification Management that monitors suppliers and third parties patronizing their products all around the globe.
Companies which are developing pharmaceutical products have a growing need to evaluate their relationships with third party vendors due to increased regulations. There is also focus on the revenues generation and increase in contracted responsibilities. Third party vendors are now used in various areas of manufacturing process.
Areas of concern for many pharmaceutical companies are focused on vendor efficiency, quality, security, fulfillment of contractual obligations, and compliance with different regulations. Across all vendor relationships, pharmaceutical companies should be interested in current vendor operating controls to regulate vendor activities to identify potential risks by current monitoring techniques and the degree of oversight by sponsor.
Vendor Qualification seeks to determine if the vendors can conveniently provide necessary goods or services to the standards of the purchasing company or regulatory institution.
AmpleLogic 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.
Challenges in Vendor Qualification in Pharmaceutical Industry
A pharmaceutical industry must procure adequate 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 the following sequential steps:
- Analyzing Requirements
- Vendor Selection
- Request for Proposal (RFP)
- Selection and Negotiation
Currently, there is no software or tools to support vendor management qualification functions. The fact that it is basically manual mean that it is time-consuming, they are unable to produce accurate vendor risk reports.
There is no standard template for RFP (Request for Proposal). Hence, preparing and completing an RFP will consume a lot of time and hence it leads to delay in Selection Process.
There is continuous monitoring and keeping track of activities. Documentation is also very difficult while doing it manually when the list and number of suppliers are high.
This manual process affects communication greatly. Also feedback is deficient, and inputs from these vendors’ stalls investigations and enhancement processes greatly.
Lack of visibility makes it impossible to evaluate the performances of the suppliers. This defect can also be attributed to the entire process being manual.
Tracking these issues by using the paper-based or excel spreadsheets becomes time-consuming and prone to errors. To meet these requirements, AmpleLogic developed an automated Vendor Qualification Solution which simplifies the identification of supplier quality issues and enhances vendor qualification management.
Features of AmpleLogic Vendor Management Software
It is a web-based platform and hence, qualification of new suppliers is easy and a lot more efficient with capturing of information through an organized section, auto selections, and limited manual entry. The system also comes with an automated routing with which the proposed vendors can be taken up for assessment easily without the delays encountered with the manual process.
Robust Vendor Assessment
They are assessed through a series of tasks that establish workflows between the organization and suppliers. They also enable live tracking of supplier activities. For example, Vendor Questionnaire can be prepared, assigned to multiple suppliers and tracked simultaneously for closure with due dates.
Integrated Audit Management
The Vendor Management Solution is designed to integrate seamlessly with Audit Management to manage their own audits and ensure that it is patterned according to the manufacturer’s and regulatory institution. The associated finding or investigations at their site and its closure are coordinated at Audit Management.
Integrated CAPA Management
The AmpleLogic 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.
Potential risks are prevented by organizations because this solution provides tools to analyze with quality metrics across a very wide range and with multiple options to choose from.
The Vendor Management System allows multiple suppliers to be compared and scored based on their quality metrics and other criteria like 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 feature that ensures the users can be automatically communicated at specific frequencies and at defined workflow steps as regards 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 and escalations.
Critical Advantages of Vendor Management System Software
- Vendor Registration Process 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
- After sample evaluation, the system assigns a Provisional Vendor Allotment Number (Temporary Registration) which then converts to Approved List after successful evaluation of the trial sample.
- It comes with a comprehensive vendor list ratings which will aid organizations to keep track of qualified suppliers who are streamlined to their organization over a period of several transactions.
- Vendor Analysis and Assessment can be done based on complete data available in the repository.
- This system automatically generate Agreement Completion Reports so that organizations can track renewals.
- AmpleLogic vendor qualification system generates dash boards, customized reports, form reports and Approved/ Rejected List and Graphical reports for reference
- Managing of transitions from one party to another, can often result in a break of supplies and loss of income.
- At different stages such as Cancelled, Approved and Discontinued of Vendor Qualification Procedure can be traced out easily with system.
- AmpleLogic Vendor Management Solution can generate additional metrics like top 10 vendors score, top 10 raw materials score, etc.
- Quality metric tools such as Vendor Quality Score, Sample Evaluation Quality Score, and Quality Score Average organizations can increase the performance of the suppliers.
- Organizations with the vendor qualification system software can concentrate on their core business and do not have to worry about the activities of vendors. This is when the organization functions on a Vendor Qualification streamlined with automation.
Alerts and notifications
- With an automated processes and alert notifications/escalations, timely response to a vendor’s query goes a long way to ensure efficiency as well as stability. Thus, enabling companies to form long-lasting partnerships with suppliers.
AmpleLogic Vendor Management Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH