Working in the pharmaceutical industry, exceeding compliance standards is essential. But, compliance management is a difficult task, and without the proper resources, it can become overwhelming. How often have you double-checked reporting to ensure there are no errors or scrambled to replace a piece of vital equipment that suddenly broke down? These small errors pile up quickly, and before you know it, it’s time for an audit, and your team isn’t prepared.

What if you had software that could automate these frustrating and time-consuming tasks, reducing and even removing the risk of human error? Your software sidekick informing you proactively when equipment maintenance is due, and inventory has to be replaced. Here, our team discusses why you should be utilizing FM software for compliance management in your pharma facility and how to use automation tools to manage ISO compliance.

What Are ISO Standards?

If you are in the pharmaceutical industry, you probably know the ins and outs of ISO. If you’re new to the ISO world, let’s break it down for you. ISO, or the International Organization for Standardization, develops and publishes international standards for multiple industries, including pharmaceutical manufacturing. 

ISO standards are internationally agreed upon by experts and often explained as a formula that describes the best way of doing something. While ISO does not have a regulatory law, meaning they are legally not mandatory, they are trusted internationally, and obtaining ISO compliance and certification is exceptionally beneficial for your organization. 

ISO 9001: Quality Management

ISO 9001 is one of the most widely known ISO certifications, which sets out criteria for a quality management system. While this is not siloed to the pharmaceutical industry, it is one of the most prominent certifications. So, how can facilities management software help you with ISO 9001 certification?

For pharma, documentation isn’t a luxury; it’s a necessity. Often, large-scale facilities struggle to keep documents organized, both print and digitally. Your team can optimize document storage through document management workflows by utilizing barcode systems, RFID tags, and more. This can include procedures for preventative maintenance, audits, and more. Additionally, task management workflows for work orders and preventative maintenance significantly assist with this certification, providing detailed data on task completion times, approvals, and scheduling.

ISO 13485 and 17664: Medical Devices

ISO 13485 and 17664 are both related to medical devices essential to the healthcare and pharmaceutical industries. ISO 13485 is based on quality management, in which an organization needs to demonstrate its ability to consistently meet regulatory requirements regarding medical devices, including the following life stages: 

• Design and development
• Production
• Storage and distribution
• Installation 
• Servicing 

ISO 17664 also relates to medical devices, with a focus on critical and semi-critical devices. The requirements for this standard include the following activities: 

• Preparation before cleaning
• Cleaning, disinfection, and drying
• Inspection and maintenance
• Packaging 
• Sterilization
• Storage and transportation 

For facilities managers, having software that can automate these processes and streamline inefficient workflows is key. Comprehensive FM platforms like Intra provide pharma-specific solutions for managing these times through strategic task management and preventative maintenance tools for automating cleaning, inspection, and audit schedules for equipment. Furthermore, these software tools don’t just focus on last-mile but last-yard delivery, with tools for customizing storage and transportation protocols to ensure safety for all equipment. 

ISO 50001: Energy Management

For FMs, your job often goes beyond daily tasks, focusing on a strategic approach to improve business operations overall. This includes managing energy efficiency in your facility, especially as ESG initiatives continue to expand internationally. ISO 50001 is a recent standard for energy management, providing the framework to help teams use data to understand their energy use and identify any gaps that are both expending unnecessary energy as well as additional costs. With modern FM software like Intra, energy management becomes a breeze. With business intelligence tools, including configurable analytics dashboards, your team can monitor the energy expenditure of equipment and spaces within your facility. As a result, you can integrate with multiple other systems to automate timers to conserve energy. 

FM Software Made for Pharma: Intra

Working in pharma, it can be difficult to implement new technology, especially with the stringent requirements and complexity of the industry. Intra was developed to serve the unique needs of the pharmaceutical industry, monitoring current changes and developing solutions for the future. Having the right FM software goes beyond saving a little time in your daily tasks; it completely alters your daily workflows, creating a streamlined and efficient workspace with safety and security at the forefront. To learn more about our pharma-specific solutions, schedule a demo with our team today or email [email protected] with any questions.