Part of the standards established by international regulatory authorities such as the FDA, MHRA, and EU Annex 11 is for pharmaceutical and life sciences companies to create and design an Effective Vendor Qualification Management system that checks vendors and third parties who patronize their products globally.
As restrictions tighten, pharmaceutical companies must examine their partnerships with third-party providers more than ever before. There is also an emphasis on the creation of income and the expansion of contracted duties. Many parts of the production process increasingly rely on third-party providers.
Several pharmaceutical businesses are concerned about the effectiveness, quality, security, and compliance with various requirements of their vendors. Pharmaceutical firms should be interested in existing vendor operational controls to manage vendor operations to detect possible hazards using current monitoring techniques and the level of sponsor supervision across all vendor relationships.
Purchasing companies and regulatory agencies use Vendor Qualification to verify if the suppliers can deliver the essential products and services quickly and easily to their standards.
Companies can keep a vendor management system that provides total control and visibility over data and documents associated with each supplier by using the Pharmaceutical Vendor Qualification Solution from AmpleLogic.
To manufacture a tablet, a pharmaceutical company must have access to sufficient raw ingredients. As a result, several raw materials and active components are necessary for the production of a finished product.
The process of vendor qualification procedure involves the following sequential steps:
Vendor management qualification functions are not yet supported by any software or other solutions of this type. Because it is largely done manually, it takes a long time and many times results in inaccurate vendor risk reports.
RFPs (Request for Proposal) don’t have a uniform template. As a result, drafting and executing an RFP takes a significant amount of time, resulting in a delay in the selection process.
The activities are constantly monitored and recorded. When there is a long list of suppliers and a large number of them, documentation becomes quite tough.
Due to the manual nature of this procedure, there is a significant impact on communication. Also, feedback is lacking, and the contributions of these vendors significantly slow down the investigation and improvement processes.
Due to a lack of visibility, it is difficult to evaluate suppliers’ performance. Additionally, this issue might be ascribed to the fact that the entire procedure is manual.
Keeping track of these problems on paper or in excel spreadsheets takes effort and is prone to mistakes. AmpleLogic has created this Vendor Qualification Solution that automates the process of identifying supplier quality concerns and improving vendor qualification management in order to satisfy these needs.
Because it is a web-based platform, qualifying new suppliers is simple and much more effective, as information is captured through a structured section, auto selections, and little manual entry. Additionally, the system has an automatic routing feature that enables the suggested vendors to be evaluated quickly and without the delays associated with the manual procedure.
Robust Vendor Assessment
In order to evaluate them, they must complete a set of activities that build workflows between the business and its suppliers. They can also keep tabs on supplier activity in real-time. Vendor Questionnaire, as an example, can be developed, and issued to several suppliers, and monitored concurrently as it nears completion.
Integrated Audit Management
To handle their audits and guarantee that they are patterned per the manufacturer’s and regulatory institution, the Vendor Management Solution is intended to easily connect with Audit Management. The Audit Management coordinates any findings or investigations made at their location, as well as the site’s eventual closure.
Integrated CAPA Management
CAPAs originating from vendor audit findings may be tracked in real-time using AmpleLogic’s Vendor Qualification System. Traceability checks will be set up seamlessly across all proposals, and the timescales for proposing them for supply trial review will be shortened as a consequence.
Real-time Issue Tracking
With traceability, any current issues can be detected, addressed quickly, and monitored for a quicker resolution.
Quality Metrics
Organizations may avoid risks by utilizing this solution’s quality indicators and numerous alternatives for data analysis across a wide range.
Ratings
Multiple vendors can be compared and assessed using the Vendor Management System’s quality metrics and other parameters, such as pricing. This ensures that the Vendor Qualification is used to analyze, choose, and promote them based on their trustworthiness, track record, and performance.
Automated Alerts & Notifications
As the deadline for required activities approaches, this feature ensures users can be automatically communicated with at precise intervals and defined workflow steps. Follow-up emails are automatically sent to the user’s email account, and escalation notifications notify users directly.
Vendor registration
Vendor Ratings
Report Generation
Vendor Metrics
Saving Time
Alerts and notifications
AmpleLogic Vendor Management Software complies with electronic record standards established by the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.
Please contact us for additional information on how AmpleLogic Vendor Qualification System can benefit your organization.
