Things change very fast in the world of mobile apps. Besides the mobile phone manufacturers adding better cameras, processors, accelerometers, and gyroscopes; mobile app developers are following those upgrades up with new and improved apps. When talking about mobile medical apps, you probably wondered if the FDA regulates them. The answer has been changing, and we will present some of the latest rules brought by the FDA to make the picture somewhat more transparent.

Groups of Apps Regulated by the FDA

Before you conduct a regulatory assessment, you should determine whether your mobile app is affected by FDA's regulations. The FDA has been evident in their mobile medical app guidance that they intend to use a risk-based approach when applying their rules. Mobile medical apps that could pose a risk to a patient’s safety or health are the only ones the FDA regulates. There are four possible groups of apps, following the FDA’s way of sorting them:

1. The app is not a medical device,
2. Even if it is a medical device, the FDA has said that they will not regulate it,
3. The FDA will regulate because they said that it is an app, and
4. None of the above.

Apps that fall into groups 1 and two are not regulated by the FDA, while apps from the fourth group are those without analogs in any known examples. Apps from the group 4 are likely to be controlled. It is explained in the FDA’s “Guidance for Industry and Food & Drug Administration Staff” guidance document.

More Challenges with Proving FDA Compliance

The surge of mobile healthcare apps is the surge behind FDA’s regulatory updates and changes in medical app development. According to the Mobile Medical Applications Guidance for Industry and Food & Drug Administration Staff guidance, a medical app is considered to be an app that works as an accessory to transform a mobile medical platform for a form of medical use or augment, supplement, or support an existing medical device. To ensure the effectiveness and safety of medical apps, the FDA will use the same risk-based approach that it uses for other medical devices.

The Emergence of the De Novo Pathway Trend

PMA (Premarket Approval and 510(k) pathways for putting a product on the market have been more popular than De Novo pathway, but this is changing. It is happening because the FDA is streamlining the application process without requiring a 510(k) anymore. What De Novo method provides is a way to classify new medical devices as Class I or II when there’s no predicate device. If a person believes that their medical device is appropriate for classification into these two Classes, they can submit a de novo request without preceding NSE and 510(k). The De Novo pathway is highly risk-based, which means that you can get a product on the market without a lengthy premarket approval application (PMA.) It is only if your new technology isn’t considered high risk and you’re able to demonstrate how all known risks can be mitigated.

New and innovative ways for health improvement and better health care delivery are being opened with the widespread use and adoption of mobile technologies. The FDA is there to encourage mobile medical app development and has a responsibility to oversee their effectiveness and safety. If you’re conducting a digital transformation to be FDA compliant with all new regulations and laws, involve your compliance team to ensure alignment from the beginning.

Rapidly changing technologies primarily drive Digital Transformation, but its adoption is dependent on a carefully planned out strategy. Big companies and organizations that adopt digital transformation have their goals and digitalization objectives predefined. It helps the process of digital conversion to be fully integrated into the business process rather than optimizing ad-hoc functionalities.

In short, real benefits of digital transformation do not lie in optimizing individual technologies used rather than the overall integration and dependencies of the whole system.

Quality dramatically impacts all aspects of business such as profitability, brand equity and overall operational efficiency and business performance. Thus, an enterprise quality management system is placed at the core of the value chain of each business, and most medium-to-high level enterprises implement it as a backbone of their business operations.

So let’s lay out a few steps to creating a digital transformation strategy for your eQMS integration.

Assess Your Quality Capabilities - Needs, Strengths, and Weaknesses

As mentioned above, you need to lay out a structure and define what quality management aspects you need improving. Surely there are weak points in your workflow that need addressing both in technical and cultural aspects of your business operations. Digital transformation doesn’t happen overnight, and as with any automation or new technology adoption, your business operational efficiency will be impacted. It will happen either because of new technology integration and it’s compliance with existing architecture, or training and education needed for it to be adopted by employees.

Understand Different Approaches That Can Be Taken

Enterprises try to integrate eQMS as an ad-hoc solution to solving specific pain points of the system such is CAPA and doc control. Again, quality management system should be at the core of a value chain as it affects multiple modules such as CRM, MOM, PLM, and SCM. If ERP orchestrates the business processes, the eQMS plays a role in quality management throughout the whole process chain. If you are looking for a digital transformation of a specific aspect of a business, you should look into different approaches to achieve this. However, in long-term, a well-designed strategy around streamlined architecture backed with an eQMS is hugely beneficial.

Determine the Gaps in Functionalities and Invest in IT Architecture

We’ve already mentioned some of the main obstacles when adopting new technologies and making integration to existing business operations and workflow. The effect of this can be dampened by reevaluating the whole business operation processes and pointing out gaps in architecture and operational efficiency that could be improved. Investing in IT architecture of one medium-to-large enterprise can present a considerable expense; however, if planned out correctly it gives a proportional ROI.

Your Next Step

Regardless of industry or organizational complexity a great eQMS is defined by five essential elements - process integration, flexibility and extensibility of the system, centralized monitoring and management, compliance enablement, and culture and quality compliance. Most organizations today build their own QMS solutions or push ERP to their limits because they fear their business operational efficiency will be negatively hit throughout the transition period of digital transformation.

And this is where Intellect eQMS comes into play. We’ve built an out of the box eQMS that is compliant with most industries or business verticals. A solution that can be highly customized to adapt to your business processes and enable a smooth transition to digital transformation of your Quality Management without damaging your workflow.

To ensure quality and safety, it’s critical for the food industry to manage and track non-conformances that can lead to product defects and disastrous mistakes.

Risk Management tools and practices were specifically developed to protect against these food safety dangers. By leveraging them, the food industry can protect itself from the risk of a lawsuit, accident, deliberate acts, and even acts of nature.

From supply chain to food health, the food industry cannot be entirely free from internal failure or external events that can threaten productivity and safety. However, having risk management practices in place puts you in a better position to protect yourself from the risks your business is exposed to every day.

If you want your food business to be profitable, you need to pay close attention to all the details; this includes everything from ingredients to equipment to your workforce; most importantly, it involves focusing on defining processes and policies. Here are some best practices in risk management:

Identify Responsible Parties

The key to managing risk is to identify all parties that are involved. It’s critical to understand who is accountable for food safety risk, quality, and compliance. 

When it comes to minimizing risks with manufacturing foods, everyone should recognize that it is a responsibility shared across all levels; this involves plant managers, quality, and food safety group, corporate supply chain, operations staff, QA personnel, and your maintenance crew.

Your QA personnel plays a significant role at all stages of production, making them critical to your overall risk management plan. Without diligence in documenting areas of high risk and communicating concerns to relevant stakeholders, risk cannot be mitigated.

Prepare Employees with Thorough and Continuous Training

Your employees handle day-to-day processes; therefore, risks start with your people. To lessen the possibility of devastating situations, your team should be properly trained in equipment handling, customer service, and safety procedures. Ensure they’re across on employee health codes that outline employee hygiene, inspections, regulated equipment, and even which cleaners are acceptable to use on facilities and surfaces.

While equipment may seem self-explanatory, it would surprise you how many times the wrong assumptions on how to operate equipment has led to disastrous accidents. To boost compliance, train employees how to properly handle all equipment. Thoroughly explain safety protocols that include proper handling, storage, and preparation of food items.

Leverage Technology 

Empower staff with food safety software that complements your overall risk management efforts. Visibility, communication, and compliance can all be improved by using the right solutions.

Communication is crucial. Without it, contamination risks may not be addressed immediately. Safety and quality are all put at risk when there is a breakdown in the exchange of information, leading to dangerous consequences.

With the right food safety and risk management software, you can establish a safety plan that meets FDA Food Safety Modernization Act (FSMA) compliance requirements and optimize operations by standardizing practices and eliminating duplication of documentation. You can increase productivity by automating manual processes that are repetitive and slow down productivity. And because you have access to historical data, you can analyze and predict trends and identify risks.

What business doesn’t want to speed up decision-making, assure quality, and improve collaboration thanks to enhanced visibility? Because of the digital revolution, all those things are achievable. However, before companies can get to that point, they need to embrace change, let go of outdated processes and undergo a digital transformation.

The transition involves leveraging digital technologies to enhance business models, processes, and activities. The change brought on by a digital transformation means letting go of old approaches and adopting a new IT system, letting go of legacy operations that are no longer effective or close to becoming obsolete.

Workflows become automated, resulting in improved efficiency which increases productivity and profitability. Your company will enjoy enhanced accessibility as digital processes become available anywhere via connected devices. And with quicker access to up-to-date data, your leaders can make better decisions faster.

Here are some more ways that a digital transformation will help optimize your business.

Better And Deeper Capabilites

Digitizing your company also means the capability to leverage software and tools that revolutionize the way companies operate; these solutions include Enterprise Resource Planning (ERP), Customer Relationship Management (CRM) systems, Business Process Management (BPS), and Quality Management System (QMS).

Better Quality And Performance

To ensure excellence in products and internal processes, quality management cannot be stressed enough. Quality management is what allows organizations to identify their weakness and areas that need to be fortified.

The quality of a product is based on a number of factors: durability, reliability, and performance. Quality is what businesses can ultimately use to differentiate themselves from their competitors. It’s what keep customers loyal and satisfied. QMS eliminates defects, ensuring you’re consistently creating quality products and services that meet expectations.

Putting Your QMS Solution To Work

A QMS solution allows your business to effectively manage and approve quality, risk, governance, and compliance. Without QMS software, companies wouldn’t have a formalized system that effectively documents policies and processes to ensure they are compliant and meet mandatory FDA regulations.

The right QMS solution optimizes your business, saving your company money, improving quality, safety, and compliance. By executing a QMS, the frequency of quality issues is decreased, allowing you to save on costs that would be lost due to multiple errors that outdated systems are prone to.

The right QMS also helps train employees who must understand their roles in the quality management process. It creates a standard that results in fewer errors and improved response time to obstacles that prove costly if not approached immediately. And with a feature that measures data points, you are in a better position to manage risk as well as analyze existing risks.

Ultimately, your business’s digital transformation and adoption of innovative software and tools such as QMS mean the ability to automate business processes that lead to operation optimization. The whole process radically changes your business, allowing you catch up with competition who adopted innovative practices early on. Not only are you saving costs by effectively managing risk and reducing errors, but you’re also increasing revenues because you’re consistently producing quality products that your customers love.

All companies, regardless of industry, are responsible for ensuring that their policies and processes are designed to comply with applicable laws and regulations. Because of the complexities of regulations and requirements, many companies struggle to secure compliance.

Companies who compliment their efforts with technology have found that staying compliant has become far less challenging. In the past, businesses had no choice but to rely on Excel sheets and Word docs to keep track of all their people and processes. It meant exchanging numerous emails and risking communications getting lost. Innovative software means the end to duplicate reporting and copying data repeatedly.

These centralized technology tools meant having confidence in your compliance and meeting regulatory requirements. Compliance workflow automation gives you the ability to audit multiple tasks into one process and schedule these processes to run on a regular basis automatically.

While the technology has been revolutionary, it still doesn’t relieve compliance teams of monitoring people, processes, and anyone else who must meet compliance obligations.

One of the crucial steps to ensuring compliance is streamlining workflows to ensure that only employees who should have access to specific data have relevant access. The purpose of a workflow is to divide processes into smaller steps which are passed to different people with the company.

Because of the multiple exchange of hands in documents, there could be numerous submissions for review and need for amendments. All the necessary steps should be taken into account and control processes must be enforced, and verification of information should be ensured.

Here are some tips track and monitor workflows to ensure that they achieve compliance, and nothing is overlooked or goes missing:

1. Identify Legal Obligations

What are all the compliance obligations and how do they impact your business? Once you have identified what these are, interpret them into specific compliance requirement statements.

Each of these requirements should be organized according to underlying regulations and codes along with common requirements such as policy development and monitoring requirements.

2. List All Parties Subject to Audits

List everyone who will be held responsible for meeting compliance obligations; this includes people, vendors, 3rd parties, sites, and processes. Because this will likely be a comprehensive list, be sure to organize them in department folders.

3. Evaluate Level of Risk

It’s impossible to monitor every aspect of your business at all times; instead of attempting to do so, focus your attention on where risk is highest. Identify who you would consider as compliance risks to your business based on criteria that evaluate the levels of risk.

4. Determine of Level of Attention

Set up your system to conduct audits regularly. Audit frequency should be established based on the level of risk. For obvious reasons, high-risk people, processes, and parties should be audited more frequently than those that are considered as low-level risks.

While the right software can help you achieve workflow compliance, the reality is that your employees are the risk that you will have the least control over. To become fully compliant, it’s important to not only streamline your processes and systems but also regularly review your people.

For businesses to keep up with the competition and respond to the change in consumer demand, they need to let go of outdated interfaces and practices. But before a company can make the digital transformation, it needs to decide how ready they are.

Beyond adapting to new IT systems and equipment, business culture will also be transformed. Not only will leadership need to establish a digital transformation strategy in relation to systems, process, and technology, but it needs to manage any resistance from employees who may worry about being replaced by new technology.

As you prepare for your digital transformation, alleviate the fears of your employees by empowering them with knowledge through updates and training. Your compliance team should also be involved in the early stages of your digital transformation to ensure alignment and keep all departments on the same digital page with regards to conducting business in full compliance with all laws and regulations.

In preparation for the transition, establish where your company is currently and what your goals are. You also have to determine if your organization has the resources and expertise to get you there. There are three main categories that your company is probably currently in:

Legacy system -  A legacy system refers to old method technology or an outdated computer system. These systems do not integrate with IoT. And without the ability to connect via IoT, a company with a legacy system will be out of sync with real-time operations. These systems will not be fit to meet the demands of today’s digital environment.

Web-enabled – While not ideal for digital transformations that are data-intensive, web-enabled platforms provide some data interaction. They also have a more user-friendly interface.

Digital ready – Your digital transformation will be hindered if your company doesn’t have a digital-ready culture. Digital-ready cultures are those that are highly innovative and whose decision-making is data-driven. If digital ideas and solution are your default option, then your organization has a digital-first mindset and are, therefore, digital ready.

In preparation for a digital transformation, your company must have a digital-ready culture and systems. One of the crucial first steps towards your digital transformation is deciding the right type of cloud that meets your company’s specific needs. Choosing between public, private, or hybrid will depend on your budget, scalability, and how much control you want to maintain.

You will also have some decisions to make on services within the cloud itself such as Software as a service (SaaS), Platform as a Service (PaaS) and Infrastructure as a Service (IaaS). Each comes with their own pros and cons.

The next step is data migration. It’s a chance for you to eliminate the unnecessary data that will only clutter your new systems, slowing down the migration process. Think of data migration as an opportunity to start fresh with only the relevant data you need. Remember that as you migrate to a completely new system, you need to rethink best practices. What worked in the past won’t be as effective.

Remember that adapting to your new system will not happen overnight and means developing a plan that will keep your business running as changes take place. As your company embraces digital transformation, leadership must champion the change to help align employees.

The purpose of document control is to enforce controlled processes and practices in industries such as pharmaceutical, nutrition, and medical where there is a need to create, review, modify, issue, distribute, and access documents. Document control ensures critical data is indexed and searchable. It helps reduce errors in documentation and allows automation of tasks.

Document control ensures that documentation is accessible at all official points within an organization and is trusted by its users to contain accurate, up-to-date information that’s reliable and formally approved.

Document control applies to any business as it ensures efficiency, reliability, traceability, performance, quality, and safety. It is also a requirement from the ISO 9001 international standard which improves your market entry chances and gains your business a decisive competitive advantage.

ISO 9001 sets the foundation for you to increase efficiency and improve your processes and structures while minimizing your liability risk as it establishes the standards for creating and maintaining a quality management system (QMS).

Requirements of ISO 9001

• Maintain a set of procedures that cover all key processes in the business
• Monitor processes to ensure that they are effective
• Keep adequate records
• Check product output for defects, and use appropriate corrective action when necessary
• Regularly review individual processes and the quality system itself for effectiveness
• Facilitate continual improvement according to ISO 9001 standards

The Pharmaceutical Industry

In the pharmaceutical industry, document control is closely intertwined with quality control. According to the Good Manufacturing Practice (cGMP) regulations that are applied in the pharmaceutical industry, the responsibilities and procedures applicable to the quality control unit be in writing. These written procedures must be followed, and any deviations from them must be justified and documented.

The Food Industry

At the core of food control activities is the establishment of standards for safety, quality, and labeling. The food industry has a broad view of food control that involves factors such as safety, nutrition, quality, and value.

In nutrition, controlled processes include maintaining nutrient levels in food ingredients and formulating nutritional profiles that contribute to consumer interest. Appropriate documentation of procedures must be established to ensure that their control systems are defined, recorded, and maintained to permit auditing and verification that the systems have been correctly applied.

The Medical Industry

In the medical industry, document control systems are also at the heart of an effective quality system as it allows organizations to centralize their documents which include everything from work instructions to policies and procedures. An automated document control system has been the key to avoid errors committed by manual and time-consuming processes.

Document Control and Risk Management

These automated document control tools impact risk management as it significantly improves project accountability. Routing for revision and approval is automated, and access to essential documents is centralized.

Having accurate records requires access controls and tracking. Access is limited to individuals with the relevant permissions thus eliminating versioning issues, delays, or lost items. Only a system that automatically creates and stores copies of all date and automatically collects acknowledgment receipts whenever people access specific documents can accomplish that.

The ability to use mobile devices on factory floors and laboratories is transforming many aspects of manufacturing in highly-regulated manufacturing industries such as pharmaceutical, nutrition, and medical.

Regarding healthcare, mobile devices have become so common that there’s been rapid growth in the development of medical software apps. These apps assist health care professionals in communications and consulting, data and time management, health record maintenance and access, patient monitoring, education and training, and even clinical decision-making.

Many manufacturing companies have seen how mobile devices have revolutionized the healthcare industry and are now also leveraging mobile technology with the intent to use them increasingly in the monitoring of production and to ensure factory efficiency and safety.

In the past, computing and communications meant having to rely on multiple devices which included pagers, PDAs, and cellphones that could only make and receive calls. With today’s smartphones, you have all the capabilities of those electronics in one device. But beyond the ability to make voice calls and send texts, today’s smartphones and tablets have browsers, GPS, sound recorders, and high-quality cameras. And most importantly, access to industry-specific apps.

With smartphones and tablets, you can now capture data and get quality assistance from ultimately anywhere. The ability to capture everything from deviations during sampling and testing to calculating batch measurements in real-time means that non-conformance and corrective actions can be enforced almost immediately. Also, having offline capability to still capture data on mobile if there is no internet connection can help with situations where the factory floor doesn’t have good reception on the mobile device.

In manufacturing, the significant benefits of allowing workers to bring their mobile devices to the floor are giving them the ability to contact other employees, communicate with off-site personnel, and reference manufacturers’ documents. With mobile technologies, there is a significant improvement in logistics and supply chain coordination with suppliers. Customer responsiveness is enhanced thanks to the capability to integrate mobile CRM systems with order management, pricing, and fulfillment.

This improvement in efficiency is saving manufacturers significant sums of money each year. It may seem trivial when you think about how the reduction in time wasted between capturing the information and relaying it to the relevant people is a matter of minutes. However, consider how much valuable time is lost every year when you add up all those lost minutes that ultimately equate to hours, days, and weeks of misspent time. This could have easily been avoided if everyone was equipped with a mobile device that allows them to deliver up-to-the-minute data.

Factory environments are also becoming increasingly safer as workers have access to relevant and real-time data which traditionally, was confined to a desktop in the control room. Access to real-time adjustments and improvement in supplier traceability of critical materials means having the most accurate information, ensuring extra levels of safety and enhancement in quality levels.

Highly-regulated manufacturing industries such as medical products need to be constantly calibrated. With mobile-based sensors, data is captured and reported in real-time to production, allowing quality engineering teams to immediately act and ensure the floor is continuously in compliance.

Thanks to these realizations, manufacturing landscape is changing and CEOs are embracing digital transformation, prioritizing the importance of mobile technologies in the form of mobile apps and integrating them in their strategies, procedures, and processes to increase accuracy and speed to production centers. The goal is to deliver better communication, promote collaboration, and increase responsiveness to deadlines and delivery dates.

We had the pleasure to work with one of the largest food safety and quality services providers in the world. The company is known for working with clients as a trusted partner to promote public health through analysis, consulting, auditing, training, contract research, and sensory analysis services, through a network of global laboratories.

The Challenge

The multilingual global company needed a way to address and improve non-conformance response, customer complaint response, and compliance which included approvals, and documentation with Oracle CRM. The solution has to be multilingual to accommodate all their labs worldwide.

The company needed an effective solution to capture, track and maintain accurate, auditable non-conformance records through a centralized database. They wanted to streamline the process for identifying, evaluating, reviewing, and handling nonconforming parts, materials, and products and view any aspect of their workflow for complete transparency and reporting.

They also wanted to streamline customer complaints management to improve product quality and safety, decreases audit time, lower risk, and ensure FDA and ISO compliance.

The Solution

To address non-conformance, the company used Intellect’s NCM solution to create, track, and maintain accurate, auditable conformance records to ensure compliance with all management records. The “Quality Tools” app for non-conformance, customer complaints and corrective and preventive actions (CAPA) was configured to meet their exact business processes in 3 months. Employees are now assigned and notified of follow-up tasks to ensure accountability, automated email notifications and reminders.

In addition, Intellect managed their customer complaints by tracking the intake of customer complaints through investigations and CAPAs which enables continued improvement. The easy-to-use solution works on any device. Record incidents were centralized to facilitate investigations, report results better, and close cases. With Intellect’s Complaints Management, they improved communications with customers by acknowledging, tracking, and implementing any requirements that resulted in improved product quality and reduction in product recalls, ensuring compliance.

The solution met their multilingual requirements and was available to users in 8 languages, English, French, Spanish, Italian, Polish, Portuguese, Turkish and Mandarin.

The Results

The results were improved visibility to common issues for better resolution. Response time to customers on issues was improved. Internal audit tracking was overhauled resulting in reduced audits by 25%. ROI was achieved in less than 6 months. Overall, shared knowledge across the company was increased which ultimately provided considerable annual savings.

Why do people cringe at the very thought of compliance and change? Perhaps it’s because compliance means having to behave according to someone else’s command, and it’s our natural reflex to be resistant to being controlled, and skeptical of change.

But what if our reluctance to change was causing our organizations to lose massive amounts of money due to inadequacies caused by outdated processes?

The loss of revenue that occurs when document control systems are inefficient can be significant, and can cost manufacturers millions of dollars. These inefficiencies can be traced to the use of paper/hybrid-electronic systems which partially involve a manual approach or the combination of both digital and paper files. As with any manual approach, this was prone to error which resulted in delays.

And for this reason, FDA-regulated and ISO-certified companies mandated with a document change control system have shifted to automated digitized solutions which eliminate the laborious and time-consuming manual management of documents.

Here are the main benefits of an automated digitized solution for document control and how it helps ensure companies meet ISO and FDA regulations:

Easy Creation of Various Types of Documents

An automated digitized solution simplifies document creation. Different document types mean handling each document differently and may consist of separate approvers and workflows. An automated solution simplifies the creation and approval of documents, assigning the correct workflow based on each document's unique routing.

Faster Review and Approval

It’s up to the system to route documents to be reviewed by the relevant employees, ensuring final approval is received on all documents before they are used and distributed. Automated digitized solutions

have intelligent business rules that make room for deviations in the process when necessary.

Employee Training Integration

When the Training Management system is integrated with a document control system, companies can easily define which employee needs training on each document. The systems updates training records, allows self-training, and automatically updates employee status when training has been completed.

Promotes Collaboration Through Visible Reporting

When the reporting system is integrated with good document control, employees can quickly and effectively look at data to run the necessary reports. Visibility allows employees to look at data and keep business processes consistent and controlled.

Keep Data Secure Through Intuitive Filtering

A centralized system doesn’t mean that all users should be granted access. For security reasons, employees should only have the appropriate access to documents needed for them to approve, review, and make any necessary changes. A document control system allows you to filter and secure data thus limiting visibility data to only what is relevant to each user.

In conclusion, document control systems are put in place to ensure manufacturers are building products that are reliable and safe. ISO and FDA regulations are enforced to ensure that both process and documentation follow pre-approved methods.

For a company to thrive, it needs to recognize that compliance is a necessary tool that will give it a competitive edge. Achieving and maintaining compliance ultimately leads to efficiency and better output. Having an automated digitized solution helps you achieve all that by eliminating manual processes that are prone to error, giving your ability to filter access, automate redundant processes, and ensuring the correct routing and workflows.