Mobile and FDA Compliance: New Regulations in 2018

Posted by Romeo Elias on Tue, Jun 19, 2018 @ 02:00 PM

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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.

 

Tags: mobile apps, mobile applications, mobile compliance, FDA, FDA compliance, Regulations, FDA regulations, new regulations

Best Risk Management Practices For The Food Industry

Posted by Romeo Elias on Wed, May 09, 2018 @ 10:27 AM

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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.

 

Tags: risks, food industry, Risk Management, regulatory, Regulations, business process

Benefits of an Automated Digitized Solution for Document Control to Help Meet ISO and FDA Regulations

Posted by Romeo Elias on Mon, Feb 12, 2018 @ 11:56 AM

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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.

Tags: Document Control, FDA, ISO, regulatory, Regulations, automated solutions, Business Automaton

Managed Workflow Equals Quality

Posted by Romeo Elias on Tue, Jan 02, 2018 @ 12:43 PM

 

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Managing workflow in any business or industry can be like trying to tame an octopus with its many tentacles, especially in today’s tech-centric production lines. However, effective workflow management and planning can do more than lead to efficiency and cost savings. It can also increase the success of data gathering and analysis in across the board quality management systems including CAPA and Document Control.

By keeping the right people in the loop and informed though a transition to digital workflow, your management team can improve information sharing and communication. Effective workflow management stems from a variety of practices and technological inclusions that replace older practices not designed to keep up with today’s rapidly changing business environments.

Get Back On Track Quickly

No business functions without quality and improvement. Systems like CAPA and Document Control benefit from improved workflow because information is disseminated, returned, and processed more quickly and accurately. When CAPA practices detect a regulatory anomaly on a pharmaceutical or medical device production line, efficient workflow enables a rapid correction to ensure a near instantaneous return to compliance.

Efficient workflow management reduces communication discrepancies and lags that may lead to production disruptions. When companies increase the reliability of delivered information and corrective planning and action, they reduce down time and the traditional non-digital evaluation period between a business process interruption and return to service.

Communicate Effectively with Team Members

One obstacle facing production businesses, especially those operating in remote and multiple sites, is ensuring that all team members have the latest and most accurate information regarding a company goal, directive, case management, or other time-sensitive communication. Information delivery provides feedback that leads to productivity, solutions, and drives quality control and customer satisfaction. A lack of shared information results in policy and procedural breakdowns that impair quality output and other business processes.

With employees working off-site, separate from management and quality control teams, the simultaneous delivery of information and management decisions ensures that your entire team functions as a unit. Some examples of synchronized information delivery accomplished through increased workflow management include:

  • Regulatory issues and updates
  • Workload assignments
  • Customer feedback
  • Task notices and deadlines adjustments

When every member of your team receives the same information, it eliminates the occasional system-wide hiccups that interrupt quality management, production, and output. Synchronized digital delivery eliminates the redundancy of paper copies and the need to file documents at a number of locations and offices when a single cloud-based alternative serves multiple recipients.

Keep Teams on the Same Digital Page

When a business relies on compliance and regulatory issues — such as FDA directives codified at the ubiquitous 21 CFR — every member of the quality control team needs the same up-to-date information at their fingertips. Communication among management personnel relies on integrated and autonomous workflow that includes delivery to key personnel who are aware of assigned tasks and problem solving procedures.

Effective business process management demands on-the-fly delivery, communication, and tasking. When a quality issue arises, you cannot afford to have team members thumbing through outdated manuals and regulations or not knowing their position in the QMS flow.

For businesses focused on strict regulatory compliance to critical standards, workflow management assures heightened responsiveness and effective quality performance. Eliminate lag times, outdated documents, and interactive missteps with an out-of-the-box QMS solution that incorporates workflow in both CAPA and Document Control modules. Should you wish to develop your workflow by customizing these modules or creating new ones, this is an ideal solution for your business.

Tags: Workflow, QMS, Hosted Workflow, quality, Quality Management System, Quality Management Software, Workflow Managment, Workflow and Business Process Management, Workflow Process Management, workflow automation, CAPA, Regulations, regulatory, Compliance, Customer Complaints, FDA, Document Control

Compliance software is now a must have

Posted by Chris Fisher on Fri, Jun 24, 2016 @ 10:07 AM

Most mid-size and larger companies have already implemented compliance software, but it’s not uncommon for others to attempt to keep up with compliance manually or even with paper-based processes. With Sarbanes Oxley and ACA compliance becoming more regulated each year, increased accountability and visibility through all levels of management is mandatory for business.  GSA Compliance is as important. For example, if GSA finds an organization in non-compliance, auditors can suspend a contract while they determine debarment. Sarbanes-Oxley is about tracing and tracking information back to source business applications that generated the actual data. Process management, auditing functionality, cost analysis and reporting are required for any compliance based products. Documentation support and records management are other benefits that must be considered for proper compliance in any department.

The simplest solution to avoid any of these pitfalls is a compliance software or platform that can eliminate risk. A compliance assistance software integrated with an ERP or accounting system allows analysis of all source data. Intellect’s Accelerate Platform is a best-of-breed compliance assistance product that integrates with existing application program interfaces (APIs). With a compliance Platform as a Service (PaaS) all systems can seamlessly assemble information from a variety of databases to ensure compliance objectives are met.

Some benefits of compliance software is as follows:

  • Automated management reporting overdue tasks.
  • Real-time performance feedback to management.
  • Automatic cross-referencing of processes, resources and activities.
  • System reviews in workflow processes.
  • Risk assessment and JSA activities on tasks.
  • Records filtering with archived data.
  • Interactive tools for troubleshooting root causes.
  • Governance module for business planning to ensure proper outcomes.
  • Integrating ISO31000 level proactive risk management.
  • Cross referencing of documents to legislation, resources, historical activity, etc.

Managing and enforcing policy and procedures for compliance is a long-term objective and has many benefits. Reacting quickly to changes in law, enforcement actions and external events are immediate with compliance software. Creating a continuous state of readiness for audits, surveys and exams and increasing accountability and management visibility into compliance status are easily regulated with the right PaaS.  Decreasing labor intensive processes and documentation and enforcing standards and consistency throughout organizations are specific duties that can be tackled once compliance ready software is implemented. This also helps with streamlining internal audits into areas of high risk of non-compliance. Many organizations concur that by utilizing compliance software, the ROI is immediate, as is the peace of mind that comes with it. 

If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial

Tags: Compliance, Regulations, Platform as a Service (PaaS)