Vendor Qualification

Vendor Qualification Management

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.

Challenges in Vendor Qualification in Pharmaceutical Industry

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:

  • Requirements Analysis
  • Selecting a Vendor
  • Request for Proposal (RFP)
  • Evaluation
  • Selection and Negotiation

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.

Features of AmpleLogic Vendor Management Software

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. 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.

Advantages of Vendor Management System Software

Vendor registration

  • There are two methods to go about the Vendor Registration Process: either create a new one or use an existing one. When a company decides to use a new vendor, the system is automatically activated. The system will open the Approved Supplier Lists if the OTP is for an existing one.
  • The system assigns a Provisional Vendor Allotment Number (Temporary Registration) after sample review and, if the trial sample is successful, this number is converted to an Approved List.

Vendor Ratings

  •  A thorough vendor list rating is included, easy for companies to keep track of the eligible suppliers who have worked with them on multiple transactions.
  • The repository’s comprehensive data can be used for Vendor Analysis & Assessment.

Report Generation

  • This solution generates automatic Agreement Completion Reports, allowing companies to keep track of renewals.
  • For reference, the AmpleLogic vendor qualification system creates dashboards, customizable reports, form reports, and Approved/Rejected List and Graphical reports.
  • If transitions aren’t well managed, supplies may run out and revenue may be lost.
  •  Vendor Qualification Procedure phases such as Cancelled, Approved, and Discontinued may all be traced using the system

Vendor Metrics

  • Additional metrics can be generated by the AmpleLogic Vendor Management Solution, such as a ranking of the top 10 vendors, or a ranking of the top 10 raw materials, and so on.
  • Organizations can improve their suppliers’ performance by utilizing quality measure tools such as Vendor Quality Score, Sample Evaluation Quality Score, and Quality Score Average.

Saving Time

  •  It is much easier for companies to focus on their primary business when using vendor qualification system software. This occurs when the organization operates on an automated Vendor Qualification process.

Alerts and notifications

  • With automated processes and alert notifications/escalations, responding quickly to a vendor’s inquiry helps assure both efficiency and stability.  As a result, companies can establish long-term relationships with suppliers

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.