3 Compliance Issues That Can Be Solved By Automation

Posted by Romeo Elias on Mon, Jul 16, 2018 @ 01:31 PM

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For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.


Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

Tags: automated solutions, business automation, workflow automation, iso compliance, laboratory compliance, FDA compliance, mobile compliance, Compliance, CAPA, Document Control

Best Risk Management in Laboratories

Posted by Romeo Elias on Wed, Jul 11, 2018 @ 09:32 AM

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In many industries, companies seek to improve their manufacturing and product development and have to go through many regulatory reforms to do so. They require them to adopt quality systems standards which reduce risk.

Clinical laboratories don’t find themselves often in front of similar legal challenges because patients are required to give written consent, and acknowledge that their therapy involves a certain level of clinical risk. Still, risk management in a laboratory environment has become necessary due to the evolution of quality systems requirements. For best risk management in laboratories, consider these practices:

Risk Identification

Testing and quality activities conducted in laboratories have documented vulnerabilities. The most common causes of error are in the pre-preanalytical and post-analytical phases of the testing process.

These include possible errors with order entries, various sample collection errors and inappropriate handling or storage, as well as incorrect interpretation or delayed reaction to laboratory reporting. Laboratories can sometimes struggle to implement even the subtlest changes in policy or practice because it makes the overall performance prone to failures. It’s essential to identify risks in a lab’s testing process and work on preventing them. Laboratories usually deal with this through a traditionally-oriented QC approach, but that’s not always effective.

Quality Management System for Laboratories

Laboratories aren’t free from having to address all aspects of a corporate quality management system. It’s necessary for them to maintain standard operating procedures and implement control measures that can identify potential risks to the system.

ISO 15189 guides laboratories when it comes to technical and quality requirements. Laboratories must be able to record performance data and audit the results of the system, among other things. Correction and prevention of any issues that might arise from using closed-loop processes to document procedures are also paramount.

Risk Management Plan Definition

A risk management plan is crucial for the lab’s quality management plan. Each laboratory can incorporate technical requirements for testing processes into its quality management system differently. Therefore, it’s important to understand how these work to assess the effectiveness of a laboratory approach to risk management. The litmus test for this is the lab’s ability to match its planned objectives to its actual activities. If a laboratory’s execution of its TTP, IQCP or QC plan employs risk-based thinking, that’s a useful approach.

Risk Assessment and Management

In assessing and managing risk, laboratories need to keep track of all the various testing scenarios and outcomes. Once labs can understand their planning and confirm it, they’ll know which measures they need to take to deal with an unwanted result. A risk-management solution that integrates with the lab’s existing QMS could be quite useful. With it, labs could capture, communicate and address all their risk-related documentation and activities. Learning to prevent risk issues is essential. Laboratories need to be able to track risk management issues and manage their risk reporting system efficiently.

Empower your lab staff to make smarter and safer risk-related decisions by using the risk-management software. A standardized system that can fit your unique requirements can be valuable for all aspects of a laboratory’s testing and quality management plan.

Tags: Risk Management, labs, risk identification, laboratory compliance, ISO, iso compliance, risk assessment