New technologies are bringing transformation to most industries, especially healthcare. With our health systems going through changes caused by stricter compliance requirements and demands for running at peak performance, the weak links of the system are being identified and eradicated.

The lab environment is no different. We live in the time when increasing efficiency of any operation is the primary goal of creating innovative solutions. These solutions in turn help labs optimize their processes and evolve. However, ensuring quality and Operational Excellence in labs is no easy task, and it should be approached with patience and meticulousness. Here’s how a lab can achieve Operational Excellence and ensure quality:

Improving Accuracy

Inaccuracy in any part of the sample testing process can be a massive problem for labs. Since lab work is done in stages, every stage depends on how accurate was the one preceding it. One of the primary goals of any lab should be to cut down on errors during testing, considering the impact they have on the entire process.

It is also essential for labs to define and implement testing sequences that ensure lab tasks are all completed in the same manner, and at the same time in order. It helps make them more reliable and predictable, which are all attributes that go hand-in-hand with accuracy.

Improving Efficiency

Efficiency is such a broad issue that any area of the lab could have small (or huge) efficiency problems. To weed these issues out, you need to be aware of how all processes are being carried out and then evaluate how successful they are. Some of the usual inefficiency-related problems are wasted motion, overproduction, transportation, waiting, defects, inventory, and over processing.

Fixing these issues requires careful analysis, as well as developing an automated approach that addresses the most common inefficiency problems and neutralizes them. An automated workflow solution can be useful as it helps organizations by clearly showing where the hold-ups in the process are.

Improving Speed

While accuracy and efficiency are essential, speed is the one aspect of achieving Operational Excellence that seals the deal. By developing a streamlined process that ensures logistics are reliable and that specimens are accurately labeled, it’s possible to speed up the process. It helps clinicians begin patient care and treatment faster.

As you level the load and drive flow, you ensure that samples that arrive are tested as quickly as possible. Once you manage to consistently keep work flowing through the lab by leveling workload, and reduce throughput time by doing so, you’ll manage to improve the speed of the entire process.

Managing Quality

Achieving Operational Excellence by improving the efficiency, speed, and accuracy of lab processes has an added benefit of also making them compliant and creating a better quality assurance system. The ultimate goal of a lab when it comes to ensuring quality, as well as Operational Excellence, is to eliminate errors and create a reliable process. It is naturally in line with FDA expectations and best practices of the industry. Using QMS solutions with workflow automation and the ability to work in different modules helps quality assurance and brings it up to OE standard.

With Intellect QMS solutions, your lab can operate on the highest level of speed, efficiency, and accuracy. It ensures you’ll be able to both reach Operational Excellence and maximize quality assurance standards with careful implementation of industry best practices through QMS.

With the advancement of technology, more and more businesses are opting to undergo a digital transformation. It’s understandable, as it improves core business functions by making them more efficient.

However, there’s more to digital transformation than using apps that speed up a company’s processes. Innovation is an integral part of it — everyone wants an advantage over the competition which digital technologies might provide. Still, what all businesses need to understand is that digital transformation is also significant for Quality, and here’s why:

Shared Customer-Centric Focus

The end goal of digital conversion or any other IT initiative is improved end-user experience. Quality Assurance shares this focus as it aims to preserve good corporate reputation. However, that’s not the only goal of Quality Assurance — other than consistently good IT service and security for all users, QA needs to worry about the seamless launching of products and services. Staying ahead of the competition is crucial, but not at the cost of sufficient assurance of quality.

Importance for Innovation

There has been some discussion on what counts as “true” digital transformation. CIOs often merely digitally optimize their business, but they don’t transform it and innovate. It’s of paramount importance to have a good business vision when it comes to digital transformation, which is usually disruptive to the business or industry. Without QA to ensure business outcomes and a high level of customer value, that becomes even harder to accomplish.

Quality Challenges in Digital Transformation

Digital transformation covers plenty of different areas such as omnichannel solutions, IoT, and devices, mobile solutions, big data and analytics solutions, cloud services, etc. QA needs to adapt in all of these areas and provide the best customer value by focusing on eliminating some of the known weak points of each area.

For example, with mobile solutions, quality would have to work on improving the security and performance, while increasing functionality and making it all more straightforward to use than it’s ever been. To do this efficiently, QA would have to be able to test its solutions extensively — and that requires tools and expert staff.

How QA Can Meet a Company’s Digital Transformation Needs

Every QA strategy ultimately focuses on improving the end-user experience, which is what digital transformation is all about. However, working towards the same goals may not be enough. Business would still have to invest more funds into QA for it to keep up with the ever-increasing demands of IT advancement. Security and integration testing need to become a continuous practice, especially during the early stages of developing a system or software.

EQMS as a Way to Improve QA

A right way of ensuring that QA does a consistently good job throughout the entire process is using an eQMS to back up your digital transformation system. Despite the potentially high costs, if an eQMS is implemented well, it could make the process of digital transformation easier and improve your bottom line.

Our very own Intellect eQMS can quickly adapt to your company’s unique digital transformation needs. It’s an out of the box solution that can keep your workflow intact while making it possible for you to smoothly go through your digital transformation process and keep your QA on a high level.

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.

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.

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.

Operating a business in a government-regulated environment carries a high expectation of compliance and strict adherence to guidelines and policies. For companies that operate in the hyper-regulated scope of the Food and Drug Administration, software compliance is a top priority that must meet rigorously enforced standards.

There is no room for error in either medical or pharmaceutical software applications. The greatest concerns in each area focus on electronic recordkeeping and signatures (ERES) as mandated by Title 21 Part 11 of the Code of Federal Regulations.

WHO MUST COMPLY

Part 11 compliance applies primarily to medical device manufacturers and pharmaceutical companies. However, business operating in any of a number of life science product related industries must also ensure software compliance:

● Biotech and nanoscience companies

● Biologic and other drug developers

● Some cosmetic company applications

● Contract research organizations

There are few exceptions, but generally speaking, any company involved in the research, development, manufacture, or distribution of an FDA regulated product must be operating ERES software that complies with Part 11 guidelines.

FOCUSED ON RELIABILITY

Prior to cloud origination, digital conversion, and full-software integration, FDA regulated companies stored and submitted records in paper form. Hard-copy records carried a certain degree of reliability and trustworthiness necessary in the closely watched industry of medical and pharmaceutical development.

As technology advances, so have storage solutions and records. It is no longer efficient or economical to maintain volumes of paper when digital storage and filing are industry-wide norms. Twenty years ago, the FDA implemented Part 11 as part of an effort to standardize and regulate the quality, reliability, and trustworthiness of non-paper records, signatures, and filings with the agency.

Since the implementation of Part 11, software regulations have become an integral part of compliance issues and guidelines. When any company generates reports and signs off electronically, and submits digital documents to the FDA, it must comply with Part 11 regulations. Any software application used in the process must meet strict requirements.

SOFTWARE REQUIREMENTS

The FDA mandates a wide-range of complex and technical software requirements that individual companies must meet to comply with Part 11 rules. Since the accuracy and reliability of ERES data is the key focus of FDA concerns, software must include:

● Some validation process to ensure accuracy and identify altered or invalid records

● The ability to generate complete copies in various forms

● Security controls to limit access to authorized users

● Long-term storage and retrieval

● Appropriate training and tracking of electronic signature use

● Time and date stamped audit trails

In addition to these compliance requirements, companies must also have written policies regarding the use, control, and authorization of ERES systems among other strictly applied security and authenticity issues.

As technologies change and become obsolete more quickly, companies experience regular software issues and compliance questions. When evaluating software compliance, a good rule of thumb is for companies to exercise Part 11 software practices in any instance where records meet Part 11 definitions.

If your company’s software is out of date, lacks security and verification assurances, or has other compliance issues, it is time to find a solution. Ensure your company’s systems meet the latest Part 11 iterations and do not risk FDA sanctions because of a failed software audit.

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.

Workflow Modeling and Automation

A core feature of Business Process Management is Workflow Automation.  This feature enables companies to describe their business process in a block diagram view, definding the flows, the roles, the activities, and business rules.  And once defined, the Business Process Management (BPM) Platform can automate and execute this workflow, notifying users when they are required to complete a task, providing them the information they need in context to complete the work, reminding them if they are late and keeping them up to date on the overall process status.  Managers can oversee the process in real time and be notified of any delays, audit the history and decisions that were made and ensure that everyone is following the company standard.

An Example Document Workflow

The diagram above represents a document control workflow indicating the path the document followed, colored in green, to completion.

Most of the core processes in Quality Management Systems require workflow.  Document control is an obvious process where there are mutliple people collaborating together on the authoring, reviewing and approving of a document.  Workflow Modeling capability enables you to model your company's document control process, specifying all the roles, steps, rules, approvals, and decisions.  They system will then execute the workflow everytime a new document is created or is selected to be updated.  

One of the key advantages of this capability, as can be seen above, is a realtime view on the status of each document: where is it, who has it, how long has someone been reviewing it, was it approved or rejected, an so on.  A detailed and complete audit trail provides all the historical information necessary to pass any inspection or audit and to meet compliance with all ISO and 21 CFR standards.

In addition, the workflow model is defined by the company to meet their unique process needs. If the process changes, the modeler allows the company to very quickly update the workflow model so that it reflects the new process.  No programming or speciall skill sets are required.  Just an understanding of the company process and simple drag and drop.

Workflow capability is a very powerful feature to have in your QMS system.  Not only will it help you enforce your own unique company process, it also ensures everyone is following the right process, with full auditable history and visibility.

Do you have a Workflow Modeling feature in your QMS? Sign up today for a demo to see the power of Workflow + QMS.