Find out how the proper document and training management can optimize production and ensure compliance in the pharmaceutical industry.

The pharmaceutical industry is one of the most regulated in the world. And, to ensure the safety and effectiveness of medicines, a suitable document and training management is essential. This will ensure compliance with the requirements of standards and regulations, as well as guarantee the quality and safety of the pharmaceutical products produced.

In addition, the pharmaceutical industry must constantly invest in training to seek the development of the knowledge and skills of its employees. This is extremely important since the standards are constantly updated. It is necessary to ensure that all team members are aware of the changes and updates.

These two managements need to be integrated and work together. This is essential to the company success in the market, which becomes increasingly competitive and regulated. Do you want to know how to optimize these processes? Then continue reading and learn about our tips that you can put into practice and that will help you make the most of your Document and Training Management.

 Document Management in the pharmaceutical sector

 The documents are necessary to ensure that medicines are produced in accordance with the quality and safety standards required by the regulatory agencies. An effective document management system allows the pharmaceutical companies to organize, store and manage their documents efficiently. This includes the creation of policies and procedures for the review, approval, and distribution of documents, as well as the implementation of version tracking and control systems.

The document management must ensure that the entire life cycle of documents is controlled, from their creation, revision, and obsolescence to their classification, storage, and retrieval. This process should be structured, with clear procedures and constant monitoring, to ensure that all information is up to date and available for consultation.

There follow some of the best practices for document management in the pharmaceutical industry:

  • Standardization of processes: define standards for creating, storing, accessing, and reviewing documents. This helps ensure that information is available to those who need it and that all employees have the same understanding of the document management processes.
  • Electronic document management system: use of an electronic document management system to centralize and control the creation, review, approval, publication, and distribution of documents. The system allows complete traceability of changes and revisions, providing history and versions of the document.
  • Version control: ensure that all versions of a document are controlled, allowing access only to the latest version. This helps prevent potential errors or outdated information that could result in failures and health hazards.
  • Records management: keep a record of all documents, including those that have been discarded. This record must include information such as creation date, revision history and authorization. Responsibility must be clearly defined, including the maintenance and access of records.
  • Training: ensure that all employees handling pharmaceutical documents are trained in all applicable policies, procedures, and regulatory requirements. They should have a clear understanding of individual responsibilities and the role of staff in the management of pharmaceutical documents.

As we have seen, after updating procedures, it is extremely important that company employees undergo adequate training. This is because changes in the processes can involve recent technologies, tools or working methods and it is essential that all employees are well trained and informed about the updates.

Training after updating procedures helps ensure that employees are aware of the new policies and guidelines and are able to apply them in their daily activities. Without proper training, the chances of errors in the performance of critical tasks can increase, affecting the efficiency and productivity of the company. In short, training after updating procedures is essential to ensure that all employees are up to date and prepared to work following the new guidelines. This helps improve the company efficiency and productivity, as well as create a culture of continuous learning and professional development.

Training Management in the pharmaceutical sector

In addition to document management, training management is essential for the pharmaceutical industry, since it involves the training of employees responsible for the production, quality control and distribution of medicines and pharmaceutical products.

In addition, the training also helps to create a culture of continuous learning in the company, encouraging the search for new knowledge and skills. This can increase employee motivation and improve the quality of work delivered.

A good training management must consider the legislation applicable to the sector, the standards of good manufacturing practices, the occupational safety and health guidelines, in addition to the specificities of each position and process involved. Regular training serves to ensure that the activities carried out by the employees are in accordance with the current regulations. These trainings may include topics such as pharmaceutical industry regulation, good manufacturing and product handling practices, risk management and quality management systems.

To ensure the efficiency of training, it is important that they are conducted by qualified professionals, using updated and innovative teaching methodologies and techniques. In addition, it is important to use tools and technologies to facilitate the training process, such as e-learning platforms and virtual simulations, which allow remote training, reducing costs and increasing flexibility.

Another important aspect of training management for the pharmaceutical industry is the evaluation of its effectiveness, assessing if the employees have acquired the skills and knowledge necessary to perform their duties safely and efficiently. In this article, we give tips on how to evaluate the effectiveness of the training carried out: Effectiveness of training: Understand the importance to the QMS.

To carry out the training management in the pharmaceutical industry, it is necessary to follow some steps:

  1. Identify the training needs: it is important to identify the areas that need training and what are the skills that should be developed.
  2. Define the training objectives: it is necessary to establish what the training objective is, what employees are expected to learn and what skills will be developed.
  3. Choose the training methodology: it is important to choose the most appropriate methodology for each type of training, such as face-to-face courses, e-learning, among others.
  4. Define the training schedule: it is necessary to establish the dates and periods in which the training will be carried out, considering the employee availability and the department demand.
  5. Evaluate the employee performance: it is important to evaluate the performance of employees after training to verify if the objectives have been achieved and identify improvement needs.
  6. Continuous monitoring: it is essential to continuously monitor the performance and satisfaction of employees in relation to training, to ensure the effectiveness and quality of the learning process.
  7. Constantly update: it is important to keep the training updated and adequate to the regulations and good practices of the pharmaceutical industry, seeking to guarantee the safety and quality of the products manufactured and improve the team development.


As we have seen, the document and training management is essential for the pharmaceutical industry. These practices ensure that the medicines produced are safe and effective, as well as ensuring regulatory compliance. But now that you know how to improve the document and training management in your company, it is time to get to know SoftExpert Suite.

With SoftExpert Suite, pharmaceutical and biotechnology companies can map, analyze, and improve the efficiency of operations by integrating different management structures into a single platform. This includes product design, regulatory affairs, change management, electronic batch records, and more. With this solution, teams can see the entire process from end to end and identify opportunities for improvement. Do not just put out fires! The software is also a great support for collaboration between professionals,  helping to improve the way the organization serves its customers too.

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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