Sustainable compliance in the supply chain



Sustainable

Compliance

How To Get The Right Solution

Flexco offers you a data-based system to give you the full Overview of your Supply Chain from end-to-end.

  • Total overview of the Supply Chain
  • Total overview of all lanes and routes
  • Overview of compliance level through questionnaires
  • Remote Audit
  • On-site Audit in a Joint Audit Program

Overview of the Supply Chain – GDP Compliance

Remote Audit

On-site Audit in a Joint Audit Program

With the use of one stand and one approach your teams gets the full overview of the supply chain from end-to-end. Processes and Procedures can be established and updated accordingly to quality agenda and performance.

Use the database as stand alone model or join the Joint Audit program

 3 Step Overview

approach to GMP and GDP compliance

  • Certified Audits - With no other engagement than compliance
  • Compliant to GMP and GDP world-wide One approach for all entities.
  • Sustianable solutions
  • Rating Certification, rating scores for each product, substance of each rating holder and substance codes
  • Get transperancy in your compliance
  • Global Quality approach for One system, One standard and to share best practice across all entities


Joint Audit Programs

The Supply Chain is world-wide and GDP is becoming more and more important due to new requirements from the pharmaceutical medicine produceres and together with changes in the medicine product comes new specifications and demands for compliance.

How to be GDP compliant and how to hold Supply Chain integrity.

Flexco offers a database system to ensure one approach towards all suppliers and vendors in the Supply Chain.

This to ensure stability and integrity from end-to-end.

The GDP overview can be conducted on all 3PL, Vendors and Suppliers with no other agenda than compliance.

Flexco offer you a database where contacts persons and answers of questionnaires are recorded.

On-Site can anytime world-wide be performed by Partner and in compliance with EMA.

All Audits are in a joint audit program and will offer you cost-savings and time-savings.

As part of our service you get the tool to access to the predefined questionnaires for the GDP overview.

Your team can use same questionnaire and it supports generating the results. This is one approach and one standard.

All Audits are performed by the rating systems of Partner.

Flexco does not perform audits, but helps your team get a full overview.

Partner performs all aduts and host the evaluation and by having one approach and all questionnaires results in one data base. You have full control and overview of your supply chain.

Joint audits and your ability to create a full overview of the supply chain is the key to ensure supply chain integrity.

With access to the questionnaires your team can support the procurement team in the first overview of the supply chain and for which suppliers to move forward with.

The advantages are that all suppliers get the same questions and all answers can be generated in one report for evaluation a comparison.

The data-base tool offers your team a one view overview, with no other agenda than compliance. It is easy for your team to support your procurement team on all levels of quality related questions, answer are locked and can be recalled anytime for evaluation and overview

Flexco works a 3 step compliance system to support Pharmaceutical companies achieve solid solution. Flexco will deliver at database with predefined GDP related questionnaires for overview and status.

Flexco is in collaboration with Partner that is a standardized rating system which allows entities to be audited with the angle of reason.

Partner offers a joint audit program where each affiliate pays own audit and conduction.

Flexco and partner can together support the whole Supply Chain from end-to-end

Deadline for assessment of Nitrosamine is 6 months from September 19 2019.

On-site audits for impurity of Nitrosamines, can be conducted under the pricip joint audit program.

Please contact Flexco for more information.



IMPURITIES Of NITROSAMINES

IN ACTIVE PHARMACEUTICAL INGREDIENTS

Phase 1: Nov 28, 2019

  • QA application
  • Protocol, Evaluation
  • TBD

Phase 2: Dec 15. 2019

  • QA (CAE)
  • Nitrosamine Evaluation
  • TBD

Phase 3: Jan 15, 2020

  • QA
  • Deadline
  • TBD

Phase 4: Feb 15 2020

  • Dead line for EMA
  • QA
  • TBD


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