The evaluation of ERP software according to EU-GMP standards in the Pharmaceutical industry

The pharmaceutical sector increasingly emphasizes the maintenance of safety and quality in production, especially concerning data management through software systems. Assessing software compliance with Good Manufacturing Practices according to European standards (EU-GMP) is not only crucial but also an essential step to ensure that businesses in the industry adhere to the highest regulations and standards regarding safety and quality. This article addresses common questions about evaluating ERP software according to EU-GMP standards and explores the benefits of using PharmaSoft ERP software to enhance compliance and efficiency.

What is ERP software evaluation, and why is it necessary to help comply with EU-GMP standards?

One of the crucial factors in meeting EU-GMP standards is the implementation of Computerized System Validation (CSV). Computerized systems used in activities related to the production, quality control, and distribution of pharmaceutical products must comply with the requirements of Annex 11, EU-GMP. These requirements aim to ensure that computerized systems are reliable, consistent, and highly integral, as well as capable of preventing, detecting, and handling errors and misuse.

Validation is assessing and providing evidence that a computerized system or one of its components meets predefined requirements and operates as expected.

A typical example of a system that needs validation is ERP software. ERP stands for Enterprise Resource Planning, a business management software system that helps organize business activities such as finance, human resources, manufacturing, sales, customer relationship management, and supply chain. ERP can improve efficiency, reduce costs, and increase profits for pharmaceutical manufacturing enterprises. However, ERP can also risk quality, safety, and legal compliance if not thoroughly validated and controlled.

Therefore, pharmaceutical manufacturing enterprises must adhere to GMP standards, especially Annex 11 of EU-GMP, when using computerized systems, including ERP software solutions. This ensures that computerized systems can effectively and safely support the production, quality control, and distribution of pharmaceutical products.

The importance of validating ERP software?

• ✔ Ensuring Functionality According to Requirements and Functions

The validation of ERP software plays an extremely important role in the implementation of enterprise systems. Validation ensures that the developed software meets specific requirements and accurately describes the system's functions. Through the validation process, the functions of ERP software are meticulously examined to ensure completeness and accuracy, from resource management to the automation of business operations. This helps create an efficiently operating ERP system, tailored to the specific needs of the organization, providing long-term value to the business.

• ✔ Ensuring Accuracy and Reliability

ERP software validation is not only a technical process but also a tool to maintain data integrity according to the principles outlined in GMP standards. This ensures that data generated, processed, and stored in the ERP system is accurate, traceable, and most importantly, not tampered with. This helps protect the reliability of crucial information in pharmaceutical manufacturing.

• ✔ Controlling System Access

Moreover, ERP software validation plays a crucial role in complying with EU-GMP standards, especially in the context of Annex 11. Emphasizing the importance of ensuring secure and controlled access to computerized systems, plays a vital role in preventing unauthorized access and keeping data secure.

ERP software validation not only enhances the transparency of the process but also limits user access rights. This measure not only reduces the risk of unauthorized modifications but also ensures that every action in the system can be traced and accounted for by specific individuals, meeting the stringent requirements of GMP.

The stringent regulations mentioned above, combined with the support of ERP PharmaSoft, not only assist pharmaceutical businesses in complying with EU-GMP regulations but also optimize the performance of the ERP system, ensuring data integrity in the manufacturing environment. In the next section, we will address key questions related to the validation process of ERP software according to EU-GMP standards.

Some frequently asked questions about the validation of ERP software complying with EU-GMP.

In the process of deploying and maintaining ERP software in the pharmaceutical sector, a range of challenges regarding compliance and quality assurance have raised many questions for businesses. Particularly, validating ERP software according to EU-GMP standards is a crucial part of this process. Below are common questions about the validation of ERP software according to EU-GMP standards that businesses often encounter:

• 1. How does EU GMP define the scope of validating ERP software?

The European Union's Good Manufacturing Practice is a significant set of rules in the pharmaceutical industry, focusing on ensuring safety, quality, and compliance in production. In Annex 11, EU-GMP emphasizes the validation of computerized systems, including both software and hardware, as a crucial factor for the manufacturing process and quality management. This means that every software system and application used in production, supply chain management, and quality control must comply with the strict requirements of Annex 11.

With this comprehensive definition, businesses need to ensure not only the functionality and utility of the software but also the data integrity of the ERP system. The validation of ERP software focuses not only on the deployment phase but also on maintenance, upkeep, and system updates over time.

• 2. How does ERP software comply with the principles of Data Integrity?

ERP software needs to adhere to the principles of Data Integrity (ALCOA) issued by the U.S. Food and Drug Administration (FDA) and also referenced in EU-GMP guidelines. Data Integrity ensures that data is Attributable, Legible, Contemporaneous, Original, and Accurate. This linkage is crucial to maintaining the reliability of data generated and processed in the ERP system. The Data Integrity principles are referenced in EU-GMP regulations in Chapter 4 (Part I): Documentation; Chapter 6 (Part I): Quality Control; Chapter 5 (Part II): Processing Equipment (computer systems); Chapter 6 (Part II): Documentation and Records.

• 3. How long does ERP software validation take?

The time required for ERP software validation depends on the complexity of the system, project scale, and specific business requirements. Therefore, there is no specific timeframe for ERP software validation. The crucial aspect is to ensure that the validation process is conducted carefully to ensure the integrity and performance of the ERP system over an extended period.

• 4. When should ERP software undergo revalidation?

The timeframe for revalidating ERP software depends on various factors, including business developments and changes, as well as software updates. Periodic review of revalidation, as well as after significant updates, ensures that the ERP system continues to meet new regulations and maintains high performance.

Benefits of using ERP PharmaSoft in complying with EU-GMP.

In the context of the pharmaceutical industry imposing increasingly high demands on quality and compliance standards, the use of modern solutions like ERP PharmaSoft has become a decisive factor in ensuring compliance with EU-GMP standards. With immensely significant benefits, ERP PharmaSoft is a powerful management tool for pharmaceutical businesses to enhance production efficiency and comply with the strict requirements of GMP standards. The benefits of using ERP PharmaSoft for EU-GMP compliance include:

1. 1. Compliance with EU-GMP Quality Standards: ERP PharmaSoft is designed specifically for GMP compliance in the pharmaceutical sector. The software provides solutions aligned with EU-GMP standards, ensuring that the ERP system meets the specific requirements of pharmaceutical manufacturing and distribution.

2. 2. Continuous Updates and Compliance Monitoring: ERP PharmaSoft offers continuous updates and compliance monitoring. This is crucial in the context of regularly changing regulations, where maintaining GMP standards is essential. Regular updates help address new challenges and ensure ongoing compliance with evolving regulations.

3. 3. Efficient Troubleshooting and Issue Resolution: In the case of problems or deviations, ERP PharmaSoft's technical specialists provide timely and effective troubleshooting solutions. This minimizes downtime and ensures the smooth and reliable operation of the ERP system, contributing to overall efficiency in pharmaceutical production processes.

 

Therefore, validating ERP software according to EU-GMP standards is an essential factor in ensuring the accuracy, integrity, and security of data in the pharmaceutical industry. The use of ERP PharmaSoft enhances these efforts by providing suitable solutions, continuous updates, and effective issue resolution, ultimately contributing to the seamless operation of the ERP system within the framework of GMP compliance.

To learn more about the ERP PharmaSoft software system and its features designed to comply with EU-GMP regulations, please contact:

EnterSoft Software Solutions Joint Stock Company

Email: info@entersoft.com.vn - kinhdoanh@entersoft.com.vn

Phone: +(84) 28 625.88.511 - Hotline: 0985.200.060

Website: www.entersoft.com.vn

Reference:

• 1. Annex 11: Computerised Systems, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, European Medicines Agency (EMA)

• 2. Guidance on good manufacturing practice and good distribution practice: Questions and answers, European Medicines Agency (EMA)

• 3. Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry, Food And Drug Administration (FDA)