How is CSA and CSV related? How to maintain Compliance in the Medical Device Industry?
Article Context:
- What is CSA?
- What is CSV?
- Other CSA Considerations in the Life Science Industry
- Importance of CSA Guidance by FDA
What is CSA?
Computer Software Assurance (CSA) is a new methodology that takes a risk-based approach to validation activities. It was driven by the FDA and life sciences industry to streamline verification and validation (V&V) activities. Over the past few decades, the medical device industry has struggled to adopt automated processes for manufacturing and quality which have the potential to increase product quality and in turn, patient safety. The CSA framework is looking to change that.
CSA is all about using critical thinking during validation. CSA leverages principles using Risk-Based Testing methods to reasonably establish that software is operating free from defects at any time during its lifecycle and that the software functions in the intended manner (i.e., the “validated state”). Some of these newly proposed methods include simplified requirements risk assessments, unscripted testing, leveraging existing validation documents from software vendors. The CSA project as a whole, hopes to shift the validation burden from documentation to testing, because at the end of the day, the testing is finding and controlling potential software defects, not the 200 page validation document.
CSA is currently called out specifically for system software validation within the FDA’s new guidance document, but its principles may apply to many other validation areas as well.
What is CSV?
CSV stands for Computer System Validation is the end-to-end validation approach to onboarding, implementing, maintaining and retiring non-product or non-device software. Both 21 CFR Parts 11 and 820 call out the need to validate computer software that supports production or the quality system. CSV is that process.
Like many other validation approaches in the industry, CSV takes a lifecycle approach to the process. This is often called the Software Development Life Cycle or SDLC. The SDLC is a structured approach followed by organizations to develop and validate computer systems, especially in regulated industries such as Medical Device. When it comes to computer system validation (CSV), the SDLC provides a framework for managing the entire lifecycle of a software system in a systematic and controlled manner. The Key Phases include:
- Planning Phase: The planning phase is geared to understanding the scope of the validation and includes gathering requirements, creating the validation plan, and performing an overall risk assessment on the system.
- Design Phase: The design phase is all about converting the business requirements for the system and creating a detailed system design that helps automate the business process. Depending on the scope of project, coding and development may be included to identify necessary design specifications for the system.
- Testing and Verification: This phase is where CSA makes the biggest impact in an organization’s traditional CSV practices. CSA leverages a requirements’ risk assessment that identifies each User or Functional Requirement and identifies their impact. Depending on the specific requirement’s risk level, the validation team may be able to leverage other assurance activities other than the old-school “scripted test case.”
- Deployment and Release: This phase is focused on finalizing all the validation deliverables prior to system release in production. All the business SOPs, data migration, and testing should be concluded and reported on.
- Maintenance and Support: The final phase of the SDLC is all about continued verification. Once the system is live in production, issues may arise, processes may evolve and things inevitable will change. Change Management is a key tenet to ensuring that all items that have an impact to patient safety / product quality / data integrity are handled in a controlled manner.
Other CSA Considerations in the Life Science Industry
As mentioned, CSA is a critical component of modern life science organizations. CSA aims to protect the confidentiality, integrity, and availability of life science data and systems.
One key element of CSA is data governance. Data governance is the process of ensuring that data is appropriately controlled and managed. Data governance includes identifying data requirements, establishing data quality standards, and implementing data protection and integrity measures.
Implementing a good data governance program in the medical device industry is crucial for ensuring data integrity, security, and compliance. The most important aspects to consider for CSA may include:
- Establishing a Framework for Data Governance: Like CSA, it is important to have a program that outlines the structures, roles, and responsibilities of the Data Integrity (DI) team. Making sure all decision-making processes and escalations are in place for data-related issues and gaps identified. In addition, it is important to understand the applicability of DI for the organization: Which regulations apply to you?
- Classifying and Categorizing Data: Classifying and categorizing all system/ equipment data based on its sensitivity, criticality, and regulatory requirements. This will help prioritize data governance efforts, implement appropriate security measures, and determine access controls.
- Creating Data Security and Privacy Measures: Developing robust data security and privacy measures to protect sensitive and confidential information. Implement access controls, encryption, data anonymization techniques, and data breach response protocols to safeguard data from unauthorized access or disclosure.
- Creating a Data Lifecycle: Defining processes for data lifecycle management, including data creation, collection, storage, retention, archiving, and disposal. By having a process in place, the organization can ensure compliance with regulatory requirements and industry best practices is being met.
- Continuous Improvement to the Program: Regularly monitoring and assessing the effectiveness of the data governance program is critical to maintaining DI excellence. Whether it be internal audits, perform data integrity assessments, or stakeholder feedback, things can always use improvement!
Remember that data governance is an ongoing process, and it requires continuous effort, collaboration, and adaptation to evolving regulatory requirements and technological advancements.
Importance of CSA Guidance by FDA
The FDA has specific guidelines for CSA (Computer Software Assurance) that would help smooth functioning and execution for any manufacturer of medical devices. CSA or Computer Software Assurance applies to Manufacturing, Operations, and Quality System Software. The guidelines given by FDA are helpful to ensure that the highest standards of manufacturing medical devices are maintained, and the best customer service is provided to the customers. These guidelines given by FDA may ensure that all the aspects of the computer software systems are streamlined.
FAQ's
What are FDA regulations for medical devices?
The FDA monitors the usage reports and the issues occurring or analyzes any risk involving medical devices. To ensure there are no issues, the FDA has made a standard regulation that a manufacturer of medical devices is expected to follow. The role of the FDA doesn’t end here; it also does alert the health professionals and the public in case there is a hazard or risk expected using a particular device.
The main objective of the FDA is to ensure that medical devices are rightly manufactured by abiding by all guidelines, proper use of devices, and the health and safety of patients. Few regulations are listed below:
- Listing with FDA – To sell their products, all the medical device manufacturers and supply chain companies must register their organization with FDA to sell their devices
- Pre-Market Information – All the information. Regarding the usage, specifications, and risk involved, the date of manufacturing, product expiry date, etc., must be shared even before the launch of the medical devices in the market. FDA must approve the same.
- Pre–Market Approval (PMA) – It is mandatory that the manufacturers of medical devices satisfy the guidelines given by the FDA, practice fair practices, and incorporate CSA to manufacture standard medical devices. Premarket approval is a prerequisite where the manufacturer must get approval for the PMA application before starting any marketing activities.
- Investigational Device Exemption (IDE) for Clinical Studies – It means that the manufacturer should have consent from all patients using the medical devices produced by him; the label should clearly state that the medical device is for investigational use only and not for regular or continued use, accurate monitoring and of all the records and reports as received.
- Quality System Adherence – It is mandated that the guidelines received from the FDA are followed and maintained by the manufacturers. They should follow quality system requirements to ensure that their medical devices meet specified requirements.
- Labelling Mandate – The FDA has made it mandatory that all products are labeled with accurate descriptions, usage instructions, date of manufacturing, and date of expiration. It is also essential that Symbols are used to depict and make it easy for the user to understand. FDA has defined a Label as the “display of printed, written or graphic matter upon the immediate container of any article of the products.”
How do you maintain a computer system in a validation state?
Computer system validation (CSV) is a process of documenting
that is required by regulatory agencies around the world for verification.
It is a computerized system that does what it is designed to do
in a continued and consistent manner. Regulatory agencies require CSV processes to ascertain the accuracy and integrity of data in computerized systems to ensure that guidelines by FDA are adhered to, and there is product safety and are effective. The FDA requires pharmaceutical companies to establish CSV for computer systems that support the production of the following products and as applicable in other segments.
- Medical Devices
- Pharmaceuticals
- Biological
- Infant Formulas and others.
Best Way to maintain CSV
- Create a Functional Flow basis the User Requirements
- Create a Risk-based CSV.
- Create an Effective Validation Plan
- Create a Good Team.
- Create Simple Test Scripts.
- Create Good Documentation.
It is crucial to adhere to the guidelines set by FDA, and discrepancy attracts regulatory action by FDA. Hence, it is vital to keep the CSV process in order which will also help the company to maintain regulatory compliance.