The medical device industry has witnessed tremendous growth in the past 10-20 years – in terms of revenues as well as the technical complexities of the product. There have been technological evolutions too in the medical device industry, but healthcare professionals still face many obstacles in meeting their goal of delivering quality care within an affordable range of the patients.

The major reason behind the obstacles is inappropriate management of information and device records. It’s high time for healthcare professionals to realize the need for an electronic document management system for maintaining Device Master Record (DMR).

A Quick Brief About Device Master Record

A Device Master Record refers to a collection of documents and records regarding medical devices including device specifications, packaging and labeling information, instruction for use, quality assurance procedures, and process specifications, which are mandatory under 21 CFR Part 820.181.

Process of Document Control in Medical Device Industry

In the highly regulated medical device industry, document control is one of the most important processes for the company’s success – in development and manufacturing. Maintaining the design and engineering records is essential to drive the development of medical products, and the Standard Operating Procedures (SOPs) is critical to governing how the business is done. You need well-organized, revision-controls, and easy-to-audit records for meeting the regulatory compliance.

In earlier times, companies used to create and update their critical data in the form of memos, SOPs, design programs, and spreadsheets. All the changes are then printed out and circulated in color folders to get signatures from the approving bodies. And the product information is usually communicated to the designated teams, outsourced partners like manufacturers and suppliers, and other authorities through call and email.

Moreover, the critical product records like the device master record (DMR), design history file (DHF), and bill of materials (BOM) are often stored in a combination of vaults, spreadsheets, and in paper-based files. All this is followed by the loading of final BOMs to the ERP systems.

All these factors, in addition to the stringent regulatory requirements, compressed product lifecycles, geographically dispersed project teams, cost savings, and the outsourced business partnerships, tend to become challenging for efficient document control and communication in many ways:

Complexity of Records

New-Age Product Records – including Design History Files, Device Master Records, and Bills of Materials- are huge, complex, and ever-changing. Trying to make and control the changes manually to the geographically dispersed teams through spreadsheets and other formats are vulnerable to errors and inefficient. This also makes it difficult for you to maintain compliance traceability mandated by several regulations.

A Large Amount of Data

Modern records are also relational. They include a variety of relevant data and files containing metadata and much more. For example, if we talk about the Device Master Records or Design History Files – they will be different for every products and part, then there will be many revisions reflecting the changes made over the lifecycle of the device. In addition, all the drawings must be synchronized with their links for easy tracking. Also, there will be compliance data that you need to attach with the records. Do you think that spreadsheets, on-site static servers, and paper files are efficient enough to offer an integrated way to bring all the related item data together?

Maintaining Records in a Validated State

As we have already discussed in the above point, the complexity of managing data in spreadsheets and servers, we should not forget the need for a validated state to keep both the components in function. And, it is quite a challenging job. Being business owners, you must be aware of the fact that every Device Master Record and Design History File must be available to the auditors at any point in time. You must retain and keep a back-up of your records for a set number of times that is mandated by the regulations. But spreadsheets are one of the fluid assets that cannot match the level of accountability that an organization needs especially in the medical device industry.

Inefficient Change Management Process

Traditional processes that include spreadsheets and ERP systems are not integral to manage engineering change orders (ECOs). Neither they can control the changes of device master record (DMR) and associated files, nor they can create proper documentation required by the FDA for the DHF because FDA regulations require proper verification, validation, review, and documentation of ECOs in every product’s DHF. Manual circulation of the paper ECOs through colored folders won’t be safe, sustainable, and efficient practice.

Managing Revisions of Product Information

In the complete lifecycle of a product, you are supposed to create several revisions of product information and communicate the same to the internal and external teams. Ensuring that everyone in your team is referring to the latest revision of the product information, especially when it is communicated through spreadsheets and paper-based files are almost impossible. It tends to be a bigger challenge when you want the current product data from your suppliers and partners.

Why Automated Document Management and Change Control Management Solutions are Better to Maintain the DMR?

Today automated solutions are available to help companies organize, maintain and communicate product information—including the device master record (DMR), design history file (DHF) and bills of material (BOM) —to succeed in today’s competitive environment for highly-regulated industries like Pharmaceuticals, Lifesciences, Automotive, etc. Organizations today need to accelerate the introduction process for their new products while improving collaboration with their suppliers and other outsourced partners to meet compliance standards with confidence.

A recent study by Aberdeen Group reveals that most of the best-in-class companies outperform significantly well than stragglers when it comes to new product development. Such companies leverage advanced tools to improve their overall performance and profitability. There are more than 50% of companies that are likely to leverage the centralized product repositories for better use of core information by capturing, sharing, and reusing the things like bills of materials (BOMs).

If you want to have an organized structure to manage all your critical documents and their relevant changes, you should choose Qualityze Change Control Management Solution. It is built on Salesforce.com and offers complete flexibility and scalability to grow along with your business.

You can also invest in Qualityze Enterprise Quality Management Solution through which you can control all your quality management activities in a single solution.

From documenting nonconformances to performing root cause analysis for adequate CAPA actions, from creating compliance-friendly documents to manage their changes in a validated system, from training your workforce to training and managing your suppliers’ quality, and from managing audits to managing customer complaints to unleash new growth opportunities, Qualityze serves it all.

This powerful software comes with truly beneficial features and capabilities like Outlook Email Approval, Electronic Signature, Alerts and Notifications, Dashboard, Audit Trail and much more to ease your quality management processes while mitigating the operational risks. Qualityze enables you to have a closed-loop quality management system to manage your quality needs based on compliance and customer requirements.

Would like to know more about Qualityze EQMS Software? You can simply call us on +1-877-207-8616 or email us at info@qualityze.com. Our customer success team will get in touch with you. You can also request a free demo to experience next-generation capabilities in real-time, and you will also get 1-week free trial.

Organizations need effective EQMS to manage their quality management processes efficiently while mitigating compliance and operative risks. A quality management solution ensures you have streamlined processes to maintain a balanced structure and achieve organizational efficacy. But, the advantages of cloud-driven QMS are still dominating.

However, having an EQMS doesn’t necessarily ensure that you will become a quality-focused organization. Because not all EQMS solutions help establish agile quality processes in your organization that are straightforward, easy-to-use, and scalable. If you will choose the wrong solution or implement the right solution in the wrong way, you may end up complicating your quality processes even more.

And, agile quality management solution is very significant for highly regulated industries including pharmaceuticals, biomedicals, and life sciences that have to evolve with ever-changing conditions in their marketplace i.e. new regulatory standards, and customer requirements.
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Quality is, indeed, a broader aspect to understand than what it sounds. Quality Assurance, Quality Control, and Quality Management are commonly used terminologies by organizations with respect to the quality of their products and services. However, implementing a quality management software simplifies the quality operations for every industry.

But what’s the difference between the terminologies?

This post will help you understand each of them in detail. Let’s quickly start with their definitions:

Quality Assurance

It basically refers to the section of quality management that ensures the quality requirements are fulfilled – in compliance with regulatory standards as well as customer expectations. Alternatively, we can define quality assurance as a planned and systematic implementation of certain activities required to fulfil quality requirements, building trust for the brand among the potential as well as existing customers without fail.
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The organizations today are taking steps for continuous improvement of quality in their products and services to meet customer requirements and compliance standards simultaneously. The focus on continual improvement helps them to drive operational excellence while mitigating risks.

Making a holistic approach towards the organization’s operational excellence requires two aspects in the first place: Quality Management and Risk Management. Both aspects play a significant role for businesses to attain their quality goals. You can bring them together for a successful implementation of the quality management system in your organization.

In fact, quality management and risk management are often referred to as the two sides of the same coin. Let’s quickly have the definitions of Quality Management and Risk Management before further discussion:

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Building a culture of quality depends on reactive and proactive functions, processes, and workflows in the organization. However, the best approach to attain quality has always been debatable. In this post, we will look at the pros and cons of both reactive and proactive approach towards the quality issues to identify which one is better for quality management.

Though most of the companies today are equipped with advanced quality management systems; still only some of them are striving with excellence while others are still struggling for effective management of their quality issues. The only difference is their approach – some of them are leaning ahead with proactive approach while others are still relying on the reactive one.

Before any further arguments, let’s just understand both the approaches in depth. It will help you have a clear choice of approach you should take your business ahead with.
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Creating an environment of continuous improvement requires a management-driven mindset and detailed analysis of audit findings that should be conveyed at all the levels in the organization. Thanks to the advanced audit management software, it has become easier to manage audit-related activities.

The continuously changing landscape of quality standards and customer requirements has made it important for organizations to have improved, effective, and efficient auditing structure that can help them attain quality as well as operational excellence. However, the audit process should be presented as one of the tools to drive continuous improvement.
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Industry 4.0 indicates the start of a new industrial revolution to enhance communication, analysis, and utilization of the resources in the manufacturing companies by bringing together two powerful components: advanced techniques of manufacturing and internet of things.

Also referred as the fourth industrial revolution, Industry 4.0 is the digitization of industrial marketing keeping the smart manufacturing operations at the forefront. Though the term Industry 4.0 was introduced in the context of manufacturing initially, it has now covered every industry thanks to technological advancement. It is considered as a leap in quality management system driven by IoT.

Industry 4.0 comprises advanced analytics, Robotics & Automation, Big Data, Internet of Things (IoT), Artificial Intelligence, and Process Digitization across the business supply and value chain.
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Because of its complex supply chain dependencies, societal implications, widespread use of social media and its ability to impact product quality issue: even a single misstep or oversight in quality can cause massive setbacks within a matter of minutes in the automotive world. These issues are magnified in today’s global economy.

We have seen in an increase in high profile automotive recalls over the past several years that have costed a fortune to several auto giants to correct. Some have had lingering damage to their brand names resulting in lost market share.

Though these might be some of the most expensive recalls ever to strike the auto industry; they will not be the last. Every day government regulations becoming more stringent, as dissatisfied consumers uncover new product issues and increasing competition compels auto makers to deploy increasingly complex supply chains to support their businesses.
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Employee training has always been a vital component of a company’s quality culture and actually solidifies it but in certain scenarios EQMS is the best choice to effectively manage the trainings in an organization. With the added benefits of interoperability with standard documents (such as SOPs/WIs/Guidelines, etc.), CAPA, Risk Assessment etc. an EQMS way of managing trainings is becoming a trend nowadays.

The following 7 signs are in no particular order. You have to read them and decide which ones are prevalent in your organization or how many of these can you relate to?
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In ISO 9001:2015, the clause 7.2 specifically requires an organization to determine the necessary competency of employees and ensure they are qualified on the basis of appropriate education, training, or experience.

Therefore, many organizations maintain a competency matrix with nomenclatures as Qualification Matrix or Skills Matrix to determine the required competency for employees working in different functional areas to identify any skill gaps,  bridge those gaps through a well-defined competency development program such as training programs and assessments to verify employee comprehension.

Often times it is debated within organizations whether the competency matrix should be prepared and maintained by the HR Department. or the responsible Operational Managers. Though, we’ll not touch on this controversial topic here, keep in mind that the post below is specifically meant for Operational Managers to help them develop an understanding to identify the skill gaps, growth opportunities for their employees and ensure job activities are effectively completed.

A Competency Matrix is typically a table that displays people’s proficiency in specified skills and knowledge.

All businesses have the requirement for qualified employees. The more competent the people, the better potential business results. However, under certain critical environments such as technical tasks or safety compliances, it is important to understand what employees comprehend about their specific jobs tasks.

Have a look at figure 1 and take the following steps to prepare a Skills Matrix for your team:

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