Quality agreements in the pharmaceutical industry: how can companies improve management?

Discover how you can simplify the management of quality agreements in the pharmaceutical industry, making the process more secure and effective.

Pharmaceutical products are essential for people’s health and lives. Thus, they must be produced and distributed with quality, safety and effectiveness, adhering to the standards and regulations of regulatory bodies such as Anvisa, FDA and EMA.

Manufacturing medicines involves a series of complex and detailed steps, ranging from the choice of raw materials to the distribution of the final product. However, the quality of pharmaceutical products depends not only on the manufacturer that produces them, but also on suppliers. For this reason, it is extremely important to ensure suppliers are reliable and committed to the highest quality standards.

And this is where the need to establish quality agreements with suppliers in the pharmaceutical industry comes in. These agreements, formalized digitally in most cases, bring together different parties, from manufacturers and suppliers to government regulators, in pursuit of the same goal: ensuring the quality of manufactured medicines.

What is a quality agreement?

A quality agreement is a formal document that establishes the responsibilities and commitments of both the pharmaceutical manufacturer and its suppliers, aimed at ensuring the quality of products and, above all, the safety of the patient.

The main objective of a quality agreement is to ensure that pharmaceutical products satisfy current quality requirements and that pharmaceutical inputs are supplied in accordance with the characteristics and specifications determined between the pharmaceutical manufacturer and the supplier. This can include good manufacturing practice standards, specifications, testing methods and storage and transportation procedures, among others.

Furthermore, a quality agreement also determines responsibilities in cases of quality deviations or problems related to supplied products, as well as ensuring compliance with applicable standards and regulations.

The key parties involved in a quality agreement are pharmaceutical manufacturers, suppliers of raw materials, distributors, government regulators and even testing laboratories. Each party has a fundamental role in ensuring the quality of pharmaceutical products, and all parties sign the agreement, making it legally valid and binding.

The main challenges in managing this process

1. Difficulty controlling the large number of documents involved

In most cases, quality agreement files and documents are electronic and signed digitally. In this case, it is necessary to manage the Word file where the agreement was initially drafted, the file converted to PDF and the PDF file signed by the parties involved. An Excel spreadsheet is often used to organize all these documents. The large number of documents makes it difficult to manage these electronic files and maintain the data spreadsheet.

With SoftExpert Suite, the file repository is centralized, so you no longer need to manage all these files manually. Moreover, the solution eliminates the risk of failure to fill out the Excel spreadsheet and automatically updates the data, in addition to ensuring the traceability of all files.

2. Difficulty locating documents

In the case of quality deviations or audits, it is necessary to ensure quick access to quality agreements, which can take a significant amount of time to locate, with the risk of not locating the correct documents.

With SoftExpert Suite, it is easy to locate and consult documents using search filters, ensuring agility and reliability in the process. In addition, the solution ensures reliability and minimizes the risk of using obsolete documents.

3. Difficulty in processing documents and revising files among the parties involved

The process of creating and approving documents involves processing a lot of data, normally carried out via e-mails, with their status updated manually in an Excel spreadsheet. This often leads to difficulties for the Quality area to control tasks, resulting in an extremely time-consuming process.

With SoftExpert Suite, file processing can be integrated into the system’s internal flow, including external access by the supplier, ensuring the process has effective control over the status, deadlines and people responsible for each quality agreement being issued and/or revised.

4. File standards and format

It is difficult to control standards for filling in Word files among interested parties.

With SoftExpert Suite, you can work with file models, fill in data in a synchronized manner using system data and control changes, ensuring greater standardization in the process.

5. Difficulty controlling documents in the digital signing process

After issuing a quality agreement approved between the parties, it is still necessary to process the file using a digital signature tool, meaning that the area responsible has to input the file in the system and monitor the process until it is completed. Finally, it is necessary to retrieve the signed document from the platform, update the status and store the file in a repository.

With SoftExpert Suite, when the document is duly approved in the system, the file can be submitted directly using the tool, without the need to download or upload the file.

6. Difficulty managing the validity of the quality agreement

Like other contracts, a quality agreement may have a specific expiration date, and controlling this period and carrying out the renewal process before the agreement expires is often a challenge.

With SoftExpert Suite, the responsible user is notified of the document’s expiration date so they can access the system to begin the process of renewing the quality agreement.

The benefits of using SoftExpert Suite to manage quality agreements

A solution for managing quality agreements simplifies the creation, signing and control of quality agreements between the pharmaceutical manufacturer and suppliers.

SoftExpert Suite is a comprehensive tool that can assist you in this management, providing a number of benefits for managing quality agreements, such as:

  • Efficient control of electronic files: SoftExpert Suite eliminates the need to deal with multiple file formats, such as Word and PDF documents, simplifying the document management process.
  • Process automation: SoftExpert Suite automates the entire process, from creating the electronic file to digital signing, saving time and reducing the chance of human error.
  • Integration with digital signature tools: SoftExpert Suite integrates with a number of digital signature tools on the market, streamlining the process of obtaining signatures, ensuring the authenticity of documents.
  • Monitoring dashboard: SoftExpert Suite provides a monitoring dashboard that allows you to monitor the status of quality agreements in real time, giving you an overview of progress and facilitating decision making.
  • Greater operational efficiency: the automation and organization provided by SoftExpert Suite results in a significant improvement in operational efficiency, reducing time spent on manual and repetitive tasks.
  • Compliance: SoftExpert Suite helps ensure compliance with quality standards and regulations by keeping detailed and traceable records of all agreements.
  • Greater collaboration: the tool simplifies document sharing and collaboration, enabling teams to work more effectively, regardless of geographic location.
  • Greater security: SoftExpert Suite offers advanced security features, such as encryption and access control, ensuring the protection of sensitive data.

By automating processes, integrating digital signatures and providing total control, SoftExpert Suite ensures the quality of inputs and suppliers, reducing costs and promoting effective collaboration among the parties involved.


Discover how you can simplify the management of your quality agreements

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    Daiane Loeffler


    Daiane Loeffler

    Daiane Loeffler is a Business Analyst at SoftExpert. She holds a degree in Chemical Engineering from UNISOCIESC, a specialization in Process Engineering from Sustentare Business School, and a specialization in Pharmaceutical Engineering from Instituto Racine. She is experienced in the Processes and Quality Systems areas and has expertise on Good Manufacturing Practices, Risk Management, Audits, Root Cause Analysis, CAPA, FMEA, PPAP, APQP and Six Sigma.

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