Creating a Robust Framework for Life Sciences Compliance

24 March 2023  |  Reading time: 8 minutes

The ISO27001, ISO9001 standards and the GAMP5 guidelines are three of the most widely recognized and respected frameworks for information security, quality management and validation/qualification management.

When it comes to ensuring the confidentiality, integrity, and availability of (information) assets and emphasizing patient safety and process, product, and service quality, the ISO27001, ISO9001 standards and the GAMP5 guidelines truly complement and enhance each other. When combined, they create a comprehensive framework that provides a strong focus on these crucial aspects, making them a great fit for each other.

In this article, we will delve into the reasons why we believe that these three frameworks are vital for any business that prioritize protecting critical (information) assets, delivering high-quality products and services, and have to comply with regulatory requirements.

Introduction

Organizations face increasing pressure to manage their critical (information) assets, maintain product quality, and comply with regulatory requirements. The ISO27001, ISO9001 standards and the GAMP5 guidelines are designed to assist organizations in meeting these challenges by providing comprehensive frameworks to aid organizations with these challenges by improving their processes, boosting customer satisfaction, and meeting regulatory obligations, each with their own focus.

Below we’ll explore these standards in more detail, highlight their differences and similarities and explain why, despite their differences, we think they are a good combination.

ISO27001

ISO27001, also known as the Information Security Management System (ISMS) is an international standard that provides a systematic approach to managing and protecting (critical) company and customer information. ISO27001 sets out a framework of policies, procedures, and best practices that help organizations establish, implement, maintain, and continually improve their information security management systems.

The standard covers a wide range of security controls, that encompasses people, processes, and technology and focuses on a systematic and risk-based management system for information security, which involves identifying and assessing the risks to the organization’s information assets, implementing appropriate controls to manage those risks, and continually monitoring and improving the effectiveness of those controls.

ISO27001 is applicable to organizations of any size, type, or sector that need to manage the security of their information assets, including digital and non-digital information.

ISO9001

ISO9001 is an international standard for Quality Management Systems (QMS) that sets out requirements for a systematic and process-driven approach to managing an organization’s quality policies, procedures, and processes. ISO9001 sets out a framework for organizations to establish, implement, maintain, and continually improve their quality management systems.

The standard requires organizations to adopt a customer-focused mentality to their quality management systems. This means understanding customer needs and expectations and striving to meet or exceed them in order to provide high quality products and services. In addition, ISO9001 requires organizations to establish and maintain a management system for quality that includes a documented quality policy and objectives, quality planning, management review, and continual improvement processes. It covers all aspects of the organization, including management, processes, and product realization.

ISO9001 is applicable to any organization, regardless of size or industry, that wants to demonstrate its ability to consistently provide high quality products and services that meet customer and applicable regulatory requirements.

GAMP5

GAMP5, or Good Automated Manufacturing Practice, provides a guideline for the validation and qualification of computerized systems in regulated industries, such as pharmaceuticals and medical devices. It provides a risk-based approach to the design, development, implementation, and maintenance of computerized systems.

The main goal of GAMP5 is to ensure that computer systems used in the pharmaceutical and biotech industries are developed, implemented, and maintained in a way that meets regulatory requirements, ensures patient safety, and maintains product quality. To do this, it provides the framework for the entire lifecycle of a computer system, from concept to decommissioning, and includes recommendations for risk management, documentation, testing, and change management.

GAMP5 is primarily applicable to the pharmaceutical and healthcare industries, where computerized systems are used extensively for manufacturing, testing, and quality control processes.

What are the main differences?

The ISO27001, ISO9001 standards and the GAMP5 guidelines are valuable assets in helping organisations improve their operations, product quality and to protect critical information. However, it’s important to note that they serve different purposes, and their differences should be considered.

What are the similarities?

Documented Management

They all place great importance on the creation and maintenance of documented information. This includes policies, procedures, work instructions, records and other forms of documents that support the organisation, as it helps to ensure that the necessary information is available and controlled to support effective operations, regulatory compliance, and continuous improvement.

Risk Management

They all require organizations to identify, assess, and manage risks. The specific methods and processes may differ, but the core focus is on performing extensive Risk Assessments to identify threats and vulnerabilities, assessing their likelihood and impact, and implementing controls to manage those risks.

Continuous Improvement

They all emphasize the importance of continual improvement. As with Risk Management, the specific methods and processes may differ, but they all have a strong focus on setting objectives and targets, monitoring performance and taking actions to improve processes and systems. This includes performing internal audits and taking corrective and preventive actions to address nonconformities and to prevent their recurrence.

Competence, Awareness and Communication

They all require that personnel who have access to critical information, perform work affecting product or service quality, are involved in the development, implementation, and maintenance of computerized systems must:

• Possess the necessary education, training, skills, and experience to ensure that processes are carried out effectively and efficiently, while maintaining the quality and security of the products or services being offered.
• Understand their roles and responsibilities, are aware of relevant policies, objectives, their contribution to the effectiveness of the quality and security of the products or services being offered, and the implications of not conforming to requirements.
• Understand the importance of clear communication processes and that communication must be established between different teams involved in the development, implementation, and maintenance of the products or services being offered to ensure effective collaboration.

Why they work so well together

The ISO27001, ISO9001 standards and the GAMP5 guidelines provide three different frameworks, each with its own focus, objectives, applicability, and requirements. However, by combining these different elements, these standards create a comprehensive framework that ensures high quality, security, and regulatory compliance across an organization’s operations. This is particularly important in the life science industry, where ensuring patient safety, data integrity, product quality and regulatory compliance is critical.

ISO9001 provides the foundation for managing quality throughout the product lifecycle, while ISO27001 helps protect critical information related to patient data, research and development. GAMP5 provides guidance on the development and implementation of computerized systems that are compliant with regulatory requirements.

With their emphasis on risk management and continuous improvement, these three together support organizations with the identification and mitigation of risks in their operations by using risk management approaches, while continuous improvement methodologies can help them identify and address areas for improvement.

The combination of these standards and guidelines also require organizations to have competent personnel, promote awareness of quality, security, and regulatory requirements, ensure effective communication, establish and maintain documented procedures and records, and have management commitment to achieve compliance and continuous improvement. Which in turn benefits the whole of the organisation.

Summary

The combination of these standards and guidelines creates a robust framework that covers most key areas of concern for organisations operating in sectors were protecting critical (information) assets, delivering high-quality products and services and compliance with regulatory requirements is crucial.

By leveraging the strengths of each standard, organisations can create integrated systems that addresses the unique challenges and requirements of the industry. This results in a more efficient and effective management system, with improved risk management, greater transparency and enhanced regulatory compliance.

By getting both ISO27001 and ISO9001 certified and combining that with following the GAMP5 guidelines, organizations can demonstrate their commitment to security and quality, improve their overall performance and build trust with customer, regulators and stakeholders. These frameworks also help organizations to comply with several legal and regulatory requirements, and to avoid financial losses and reputational damage.

Overall, the combination of these three standards creates a comprehensive framework that promotes quality, security, regulatory compliance, risk management, and continuous improvement across an organization’s operations.