The Food and Drug Administration (FDA) is a federal agency in the United States that makes sure that food is safe and virtuous, that beauty products are not harmful to humans, and that medications, medical equipment, and consumer goods that emit radiation seem to be safe and effective.
The FDA also guarantees the protection, effectiveness, reliability, and safety of medical and veterinary drugs, immunizations, and other biopharmaceuticals to protect public health.
Evaluating regulated products, clearing products for sale, and maintaining post-market surveillance are all part of the FDA regulatory compliance process.
What is FDA Compliant Software Development?
The Life Science, healthcare and pharmaceutical industries are undergoing a technological transformation and are increasingly looking to develop custom software using the latest technologies.
The world is much more secluded than ever before, and healthcare companies are under increasing pressure to comply with regulatory bodies such as the FDA and ISO while also protecting health and undertaking regular business.
The right FDA compliance software can make a big difference. That system is most likely a cloud-based technical document management system with quality software solutions in today’s world. Specifically, cloud for healthcare can help with validation, compliance, and remote access issues, among other things.
For healthcare organizations, FDA compliant software development can make compliance and risk assessment easier. The most reliable compliance software will be – or would be a part of – a comprehensive digital quality management system (QMS) that can support compliance with ISO 9001, 21 CFR Part 11, and ISO 13485.
Who Needs FDA compliance software?
Not every software development needs to be in compliance with FDA’s regulatory requirements. Your should be looking into FDA compliant software development if your medical software falls into one of these criteria.
- Software that is a part of medical device as its component or accessory (medical device software)
- Software that is a medical device in itself (software as a medical device- SaMD)
- Software used in production of the medical device or as a part of the medical device’s quality management system.
Core Features of a FDA Compliant Software
There are a number of common features that can help with FDA and other regulatory compliance. These are some of them:
1. Workflow Management
Data integrity is of crucial importance when planning for workflow management for custom software. When a user wishes to make a transition to a governed file or submit it to cloud for audit, they start a restricted workflow.
The above forces documents to follow a set of instructions, requiring users to complete pre-defined evaluation and authorization steps. This ensures that all packages are checked, and that compliance is maintained.
2. Electronic Signatures
When a GMP document is entered into a workflow, electronic digital signatures are needed. Each person who is required to provide an electronic signature would then receive an email notifying them that a document is subject to review.
Each user’s electronic signature appears on the PDF version of the documents in the sequence in which they signed it as they evaluate or authorize it. This ensures that the right individuals see the document and makes documentation and the audit trail more efficient.
The creation of event logs also allows the administrators and users to analyze and monitor the access logs through audits for development of network intelligence.
3. Stamp with an electronic print
A print stamp and watermark would be automatically introduced in the system on every PDF reworking of a GMP file every time users view, adjust, or publish it in the cloud to provide a key timestamp. This can aid in understanding which document is the most recent and up-to-date edition and remain consistent of work across time zones.
Users will see a watermark across each document that shows the document’s status in addition to the print stamp.
A handy compare tool makes it easy to see what changes were made among versions of both CAD and Office documents.
Furthermore, when a new revision is formed, the previous revision is automatically copyrighted as “superseded,” ensuring that only the most recent version is referred to.
5. Audit Trail
These features provide a detailed and accurate audit trail, making the auditing process simple and straightforward.
This set of features, when used together, offers transformative capabilities for the Life Science technical department in terms of engineering and compliance. It also enables healthcare organizations to make well-informed decisions by allowing them to gain insights, while incorporating standard features of FDA compliant custom software such as security protocols at every user level, audit trails, program time outs and event logging.
Types of FDA Compliant Softwares
A. 21 CFR Part 11
Digital records and electronic signatures are handled the same as paper documents and handwritten signatures, according to 21 CFR Part 11. Regulated businesses must comply with the regulation if they have any electronic documents or records.
B. 21 CFR Part 211
According to 21 CFR Part 211, any regulation-controlled manufacturing firm’s manager must start manufacturing all medicinal items to make sure they are suitable for their intended usages, comply with the Promotional Authorization’s needs, and do not put patients at risk due to insufficient safety, reliability, or effectiveness.
Senior management is responsible for achieving 21 CFR Part 211 compliance, which also necessitates participation and commitment from employees in a number of departments and at all levels in the company, as well as suppliers and distributors.
C. 21 CFR Part 820
21 CFR Part 820 is a group of FDA regulations that spell out the good manufacturing practice (CGMP) needs that pharmaceutical companies in the United States must adhere to when it comes to their quality systems. These CGMP needs to ensure that medical companies have a quality management system in place that allows them to deliver effective, safe, and compliant products.
21 CFR Part 820 covers “the layout, manufacture, packaging, labeling, storage, setup, and maintenance of all completed devices meant for human use,” according to FDA, as well as the facilities and design features used in those processes.
Benefits of FDA Regulatory Compliant Software
The right FDA compliance software can provide enterprise-wide advantages such as:
- Improve quality by enabling regulatory compliance.
- Reduce the cost of collecting data.
- Improve data accuracy.
- Reduce regulatory blunders (by eliminating mistakes like misfiling)
- Control over production, quality, and other processes should be improved.
- Allow for faster searching of electronic records.
- Increase the flow of information between departments and companies.
- Reduce your total cost of ownership.
- Put in place the necessary risk management and governance procedures for installation, operational, and performance qualification.
- Assist organizations in integrating both business processes and audit functions into their systems without jeopardizing regulatory compliance quality.
- Optimize closed-loop quality processes, which will aid in the investigation of any compliance issues and the resolution of any issues.
- Reduce the risks of internal and external audits.
- Audits can be made easier with FDA 21 CFR Part 820, Part 11, and ISO 13485.
As our world progresses, more efforts will be made to improve patient health and wellbeing while also automating and streamlining the practitioner process.
FDA Compliant Custom Software Development Process
A typical medical software development life cycle comprises of the following stages.
- Quality Planning
- System Requirements Definition
- Detailed Software Requirements Specification
- Software Design Specification
- Construction or Coding
- Operation and Support
These steps provide the framework for executing the overall software development project. While there are several software life cycle models like waterfall, spiral, incremental development, rapid prototyping etc, the benefits of following an Agile approach to software development outweigh the others.
While the software development process is customized as per the unique project requirements, when you partner with experienced healthcare software developers like Arkenea, you make sure that regulatory compliance is rooted in the backbone of your software solution during the development process itself rather than added as an afterthought.
Following the principles of Agile methodology for FDA compliant custom software development, our team ensure that compliance is baked into the software solution at every step during the development process.
Here is what the FDA compliant custom software development process looks like.
1. Requirements Gathering
Through in-depth analysis of user requirements, business foresight and analyzing the competitive landscape, our team of consultants comes up with the documentation pertaining to the business requirements which lays down the groundwork for the FDA compliant custom software development.
2. Design and Development
Through a proven process that consists of wire framing, prototyping, and designing, our team of UX/UI experts takes up designing the software solution that focuses on delivering an exemplary user experience for the end users.
Based on the business requirements, you can choose an MVP-first approach which starts with development of the minimum viable product with only the core feature offerings in the first iteration of FDA compliant custom software or going all in with a full feature rich software development.
3. Testing and Validation
Following the principles of Agile development, custom software development takes place in short development cycles called as sprints. Testing and validation to ensure compliance with FDA regulations takes place in tandem rather than at the end of the development process so that security and compliance are an integral part of the software.
Our testing and validation team of quality assurance engineers and analysts ensures compliance with the 21 CFR 11 and covers all aspects of software testing including creation, review and execution of test protocols.
Development of FDA compliant custom software is just the beginning of the journey. The existing data needs to be migrated to the new systems and employees need to be trained for working on the same. The implementation stage of FDA compliant software development is not just limited to the systems going live but includes the plan for maintenance and support of the software as well.
5. FDA Software Validation
Validating the software developed involves recording of evidence that proves that the software system meets all the specifications and quality attributes, has been installed correctly, and will fulfill its intended use.
FDA has published a comprehensive guide for software validation but every organization needs to figure out what recommendation applies to them. Since they don’t know how your company intends to use the software developed, a validation plan that outlines exactly that is a must.
You thus need to have specifications and quality guidelines in place that define success. You would also need to test out the common scenarios of the software’s intended use to produce or distribute regulated products.
Are you looking for a pharmaceutical management software that is custom developed to your requirements? Arkenea is a well-known name in the custom healthcare software development industry, with over a decade of experience developing medical software for a variety of clients.