FDA and ISO Compliance
for Medical Device Manufacturers

21 CFR Part 11 is a set of regulatory requirements enforced by the FDA that govern the use of electronic records and electronic signatures in pharmaceutical, biotech, medtech, and other FDA-regulated companies. 21 CFR Part 11 guidelines were enacted to ensure the authenticity, integrity, and reliability of electronic records and signatures used in regulated industries while enabling quality and manufacturing professionals to embrace technological advancements such as modern medical device regulatory compliance software.

Medical device quality and manufacturing professionals should be aware of the following key elements of 21 CFR Part 11 for which criteria have been established.

• Electronic Records

  21 CFR Part 11 guidelines define what constitutes an electronic record and set the requirements for their creation, maintenance, and archiving. They emphasize the need to ensure that electronic records are accurate, legible, and retrievable throughout their intended retention period.

• Electronic Signatures

  The criteria for electronic signatures, which are the digital equivalent of handwritten signatures, are outlined in FDA 21 CFR Part 11. These signatures are used to authenticate electronic records, and 21 CFR Part 11 compliance requires them to be unique to the individual, securely managed, and linked to corresponding records.

• Audit Trails

  21 CFR Part 11 compliance calls for companies to implement secure and computer-generated audit trails for electronic records. Audit trails track any changes made to electronic records, allowing for a comprehensive view of the record's history, including when and by whom changes were made.

• User Authentication and Authorization

  21 CFR Part 11 guidelines call for the establishment of procedures that ensure only authorized individuals have access to electronic records and can perform specific actions, such as creating, modifying, or approving records. User authentication processes must confirm user identity.

• Training

  21 CFR Part 11 guidelines require companies to provide adequate training to personnel who use electronic systems and maintain thorough electronic records that document their understanding of the regulatory requirements and proper procedures.

• Validation

  Any electronic system used for regulated activities must be validated to demonstrate that it performs as intended and meets 21 CFR Part 11 compliance requirements. Validation involves testing and documenting system functionality, security measures, and data integrity controls.

• Data Integrity

  The underlying principle of FDA 21 CFR Part 11 is the importance of maintaining the integrity of electronic records and signatures and ensuring they are accurate, reliable, and unaltered. To prevent unauthorized changes or deletions, it's critical to have adequate and appropriate controls in place.

• Security

  FDA 21 CFR Part 11 highlights the need for robust security measures that protect electronic records from unauthorized access, alteration, or destruction. These measures encompass both procedural safeguards (like access controls) and technical safeguards (such as encryption).

• Record Retention and Retrieval

  21 CFR Part 11 guidelines specify requirements for record retention periods and retrieval capabilities. Electronic records must be available for inspection, review, and copying throughout their retention period.

• The Cost of 21 CFR Part 11 Compliance Failures

  Noncompliance with Part 11 can result in tragic consequences, such as product recalls or legal actions. If your products are subject to FDA oversight, you must ensure your electronic record-keeping practices align with the 21 CFR Part 11 compliance guidelines devised to help uphold product quality. Read on to learn how modern digital tools facilitate compliance with 21 CFR Part 11.

Simplifying 21 CFR Part 11 Compliance With Modern Digital Tools

To meet 21 CFR Part 11 guidelines, a digital document and process management system is essential for medical device manufacturersh. Modern tools like MasterControl's purpose-built solutions have been designed to simplify 21 CFR Part 11 compliance for today's quality and manufacturing professionals. For companies that have implemented medical device compliance software, compliant processes and documentation aren't a lofty goal - they're a normal part of doing business. Software built for 21 CFR Part 11 compliance can unify the goals of your quality and manufacturing departments and turn regulatory compliance into a business accelerator by providing efficiencies and benefits that include those listed below.

• Controlled, Audit-Ready Records

  Digitization helps quality and manufacturing departments ensure that documentation is complete, compliant, and readily available. Modern 21 CFR Part 11 compliance software protects all electronic records within a secure document repository accessible only to authorized users. Based on rights, users can search for and immediately retrieve records identified as permissible.

• Reliable Electronic Signatures

  A robust medical device regulatory compliance software solution will provide fields for all the information required for FDA 21 CFR Part 11-compliant signatures, including name, date/time of signing, and meaning of signature. Also, the solution should automatically link every signature to a specified record.

• Automated Audit Trail Capture

  The FDA expects electronic record users to have a system in place to capture secure, computer-generated, and time- stamped audit trails to independently record the date and time of entries and actions involved in creating, modifying, or deleting. Modern digital tools are designed to automatically capture and maintain this information and export it in human-readable format.

• User Authentication/Authorization Enforcement

  A robust 21 CFR Part 11 compliance software solution will offer multiple levels of security to ensure the authenticity of each user, document, and electronic signature in the system. Users should only be able to gain access using a unique ID and login password that cannot be duplicated or transferred. Separate, unique IDs and passwords may be required for approvals.

• Comprehensive Training and Training Records

  Digital solutions facilitate the creation and deployment of simple or extensive training courses when trainees are required to learn tasks and demonstrate competency. Trainees can be automatically tasked when essential documents change and new training becomes necessary. Modern software also automates the follow-up and escalation of past-due training and creates audit trails for all training data and records.

• Accelerated Validation

  To alleviate the validation burdens faced by any company seeking 21 CFR Part 11 compliance, providers of proven software solutions have developed pioneering and patented tools that allow their customers to dramatically accelerate validation time. A robust solution will also ensure that all audit trails are revalidated with each update.

• Sustained Data Integrity

  A reliable digital system reduces the risk of data loss, tampering, or unauthorized modification. By using software specifically designed for 21 CFR Part 11 compliance, you assure the integrity of the data in your electronic records. Proven solutions promote the reliability and accuracy of data throughout your records' entire life cycles.

The FDA's 21 CFR Part 820 Quality System Regulation (QSR) details the current good manufacturing practice (cGMP) guidelines for ensuring the safety, effectiveness, and quality of medical devices. It governs the methods, facilities, and controls used for medical device design, manufacture, packaging, labeling, storage, installation, and service. To sell and distribute products in the U.S., device manufacturers must adhere to these medical device compliance regulations.

Regulatory Harmonization of Part 820 and ISO 13485

The FDA is currently working on harmonizing the 21 CFR Part 820 regulation with the globally recognized ISO 13485 standard, which will become the Quality Management System Regulation (QMSR). Rather than companies needing to meet all requirements for both Part 820 and ISO 13485 for international compliance, the FDA will reference ISO 13485 in applicable sections of Part 820. Still, it's important to understand the medical device regulatory compliance requirements for both the ISO standard and the Part 820 regulation to ensure that you can comply with the QMSR.

Components of 21 CFR Part 820

The QSR contains a large number of detailed regulations medical device manufacturers must comply with. Some of the key requirements are outlined below.

• Risk Management

  Risk management is a pivotal area of focus for quality management. Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. Following the harmonization of 21 CFR Part 820 and ISO 13485 there will be a higher emphasis on risk management in medical device manufacturing. For 21 CFR Part 820 compliance, you must:

  • Apply risk management measures to new product development, design change, manufacturing, and postmarket surveillance.
  • Complete a risk assessment and analysis of all quality management system (QMS) processes, including outsourced processes.
  • Engage in risk control, which includes decisions to accept or mitigate risks.
  • Create and maintain records of all risk management activities.

• Document Control

  Manufacturers are required to establish and maintain procedures for creating and controlling documents. Some of the guidelines for document control include:

  • Make all relevant documents available at all locations.
  • Immediately remove obsolete documents from circulation.
  • Ensure all changes are reviewed, approved, and signed by designated stakeholders.
  • Communicate changes to all appropriate personnel to keep training up to date and prevent using obsolete work instructions.

• Device History Records

  Device history records (DHRs) are a central component of medical device manufacturing as they contain all documents that are related to manufacturing and tracking devices. For 21 CFR Part 820 compliance, you must:

  • Establish and maintain DHRs for each batch, lot, or unit.
  • Ensure your DHR contains:
    • Dates of manufacture.
    • Quantity manufactured.
    • Quantity distributed.
    • Identification label and labeling used for each production unit.

• Corrective Action/Preventive Action (CAPA)

  The purpose of CAPA is to collect and analyze information to identify, investigate, and prevent the recurrence of product and quality problems. This is necessary to demonstrate that your quality system is effective and that you can identify problems and launch a CAPA as needed. For 21 CFR Part 820 compliance, you must:

  • Launch, verify, and/or validate CAPAs.
  • Communicate CAPA activities to responsible stakeholders.
  • Provide relevant information for management review.
  • Document all CAPA activities to ensure you effectively identify, resolve, and prevent the recurrence of issues.

• Equipment Maintenance

  Manufacturers must ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, and installed according to regulatory guidelines. Companies need to facilitate the required maintenance, calibration, and cleaning. Also, provisions must be in place for equipment handling, preservation, and storage.

Simplifying 21 CFR Part 820 Compliance With Modern Digital Tools

Deploying a connected manufacturing and quality management system like MasterControl embeds efficiency and continuity into your medical device organization's culture, helping you ensure compliance with all of the 21 CFR Part 820 quality system requirements.

• Risk Management

  Risk management needs to be integrated into all areas of the company. It helps to employ a digitally connected, data- driven approach to identifying and mitigating risks before they result in costly delays, rework, or product recalls. A connected platform approach to quality and manufacturing gives you:

  • The functionality to quickly track and analyze risks.
  • Unified processes to manage risk-related activities.
  • The ability to easily recognize and mitigate risks long term.

• Document Control

  Digital quality and manufacturing solutions ensure compliance by eliminating labor-intensive tasks such as the physical routing of documents for approval, distribution, storage, and archiving. An effective document control solution includes:

  • A collaborative workspace.
  • Automated revision control.
  • A secure architecture.
  • Integration with enterprise management systems.

• Digital Production Records

  Using electronic production records means you have no paper forms or offline processes to manually reconcile. Shop floor staff can input data directly into tablets or computers. They can connect to and pull information directly from an enterprise resource planning (ERP) system as well as log customized production record documents in real time. Digital records don't accept out-of-specification (OOS) or omitted entries, so all records are error-free. Purpose-built digital solutions enable device companies to:

  • Improve product quality.
  • Shorten production cycles and reduce lead times.
  • Minimize quality issues and product recalls.

• CAPA

  A digital quality management solution alleviates many of the challenges with CAPA processes by integrating with other quality processes, such as document control, change control, deviations, and audit. A proven solution will:

  • Automate CAPA-related tasks.
  • Use built-in, robust reporting and analytics capabilities.
  • Create secure, time-stamped audit trails.
  • Automatically send users real-time notifications about CAPA tasks.
  • Allow users to access CAPA information and perform tasks from any location.

ISO 9001 is a globally recognized standard for quality management systems that provides a framework to help organizations ensure the consistent delivery of products and services that meet customer and regulatory requirements. The ISO 9001 quality management system standard gives companies a systematic approach for enhancing their processes, improving customer satisfaction, and driving continuous improvement. It empowers organizations to create a culture of quality that permeates every aspect of their operations, leading to long-term success and sustainability. The standard can be adapted to various industries and organizational sizes, and it emphasizes a process-oriented approach to quality management that focuses on well-defined processes, clear responsibilities, and a commitment to continuous improvement.

The ISO 9001 standard specifies various requirements organizations like medical device companies must meet for their quality management systems to be effective. These requirements are broadly categorized into the key areas listed below.

• Scope

  An organization seeking ISO 9001 compliance must define the scope of its QMS, specifying its boundaries and applicability.

• Normative References

  ISO 9001 refers to other standards and documents that provide guidance for the implementation of a QMS.

• Terms and Definitions

  The ISO 9001 standard defines key terms that organizations seeking medical device regulatory compliance must know.

• Context of the Organization

  ISO 9001 calls for the identification of the internal and external issues relevant to an organization's purpose and strategic direction. This includes identifying the needs and expectations of interested parties (i.e., customers, regulators, employees, etc.).

• Leadership

  ISO 9001 requires organizations to demonstrate that they have the proper leadership for and commitment to the QMS. Leadership must establish a quality policy and ensure it is communicated and understood and that responsibilities and authorities are properly assigned.

• Operation

  Processes must be implemented to meet quality objectives and requirements. Compliant operations also entail properly addressing customer communications, determining requirements, and monitoring customer satisfaction. ISO 9001's process-oriented approach calls for organizations like medical device manufacturers to define and manage their key processes, identify interactions between these processes, and continually refine them for improved efficiency and effectiveness.

• Planning

  To achieve ISO 9001 compliance, organizations must establish quality objectives that are measurable and consistent with the quality policy. They should also plan actions to address risks and opportunities.

• Support

  Organizations must be prepared to dedicate sufficient resources to an ISO 9001-compliant quality management system, including competent personnel, infrastructure, and suitable work environments. Comprehensive ISO compliance management entails an assurance of the awareness and competence of employees. The standard also requires documents to be appropriately controlled and maintained as needed for the QMS.

• Performance Evaluation

  The performance of the QMS must be continually monitored, measured, analyzed, and evaluated. Conducting internal audits and management reviews helps a medical device company assess the ongoing effectiveness of its QMS.

• Improvement

  To maintain ISO 9001 compliance, a medical device company must take actions to address nonconformities and continually improve the effectiveness of its QMS. This entails the use of CAPAs to prevent issues from recurring.

  These are the high-level regulatory requirements outlined in ISO 9001:2015, the most recent version of the standard. The standard provides detailed ISO compliance management guidelines for each area listed above, and medical device organizations seeking ISO 9001 certification must comply with these requirements and demonstrate their implementation to a certification body.

Simplifying ISO 9001 Compliance With Modern Digital Tools

The ISO 9001 standard serves as a comprehensive framework that helps companies like medical device manufacturers establish and maintain a QMS that drives customer satisfaction, process efficiency, and continuous improvement. But effective ISO compliance management isn't achievable if your company doesn't have a system that's up to the task. By implementing purpose-built regulatory compliance software that simplifies ISO 9001 compliance, medical device companies can improve their competitive positioning, build stronger customer relationships, and confidently navigate the complexities of today's regulatory environments. The following are just a few of the many benefits a modern ISO 9001-compliant QMS solution like the one offered by MasterControl can provide to companies in the medtech industry.

• Enhanced Process Efficiency

  ISO compliance management requires medical device organizations to document and improve their processes, with the intent of increasing efficiency, reducing errors, and better utilizing resources. Modern QMS solutions automate quality processes and allow medtech companies to integrate the management of documents, quality events, change control, audits, and training within one centralized platform.

• Faster, Better Decision-Making

  The ISO 9001 standard's emphasis on evidence-based decision-making is aimed at helping organizations make informed choices backed by data and analysis. With the advanced analytics and reporting capabilities built into modern QMS software solutions, appropriate personnel have easy access to the information they need to make good decisions quickly.

• Comprehensive Risk Management

  Compliance with ISO 9001 helps organizations identify and mitigate risks and avoid costly mistakes. A proven QMS that unifies and enhances visibility into all risk-related activities can give a medical device manufacturer an accurate, up- to-date, and more complete picture of the risk landscape across products, processes, and business units.

• Expanded Market Access

  ISO 9001 certification provides a competitive edge, as it demonstrates a commitment to quality and customer satisfaction. It also makes it easier to enter new markets and attract potential customers. Certification and customer satisfaction are much easier to obtain with a robust digital system that connects data and provides instant access to compliance-critical documentation.

• Culture of Continuous Improvement

  ISO 9001 encourages organizations like medical device companies to adopt a culture of continuous improvement, driving innovation and adaptation to changing market conditions. A modern, robust QMS gives medical device manufacturers better visibility into quality data and activities, which fuels the continuous improvement of quality management processes, business performance, and products.

• Greater Employee Engagement

  When employees are actively engaged in the quality management process, it fosters a greater sense of ownership, empowerment, and commitment to the organization's success. With modern ISO compliance management software, personnel stay connected to the information they need to drive success. A proven QMS automates the development and execution of training programs to ensure employees are competent and regulatory training requirements are met.

• Improved Customer Satisfaction

  By focusing on understanding and meeting customer needs, medical device companies can enhance customer satisfaction and loyalty, leading to increased repeat business and positive referrals. A modern QMS solution that integrates the processes involved in managing CAPAs, customer complaints, and quality events, positions companies to delight customers with consistently high- quality medical device products. A fully digital QMS also enhances collaboration effectiveness, which helps streamline supplier management and ultimately improves the quality of medical devices.

The ISO 13485 standard is a set of internationally recognized QMS requirements for medical device development. The standard specifies requirements for an organization involved in one or more stages of a medical device's life cycle to demonstrate its ability to provide medical devices that consistently meet customer needs and applicable regulatory requirements.

As mentioned in the previous section on 21 CFR Part 820, the FDA will be referencing ISO 13485 from its Part 820 regulation after the agency harmonizes the two to create the Quality Management System Regulation (QMSR). It's important to understand the requirements for both the ISO standard and the Part 820 regulation to ensure medical device regulatory compliance.

Components of ISO 13485

ISO 13485 is divided into clauses and subclauses that apply to specific processes in the development of medical devices, such as design control, risk management, complaints, documentation, training, etc. The sections below briefly address how the standard applies to some of the key quality management and manufacturing processes medical device managers conduct.

• Document Management

  The criteria for electronic signatures, which are the digital equivalent of handwritten signatures, are outlined in FDA 21 CFR Part 11. These signatures are used to authenticate electronic records, and 21 CFR Part 11 compliance requires them to be unique to the individual, securely managed, and linked to corresponding records.

  • Routing, approving, updating, and reapproving documents.
  • Ensuring that updated documents are distributed in a timely manner.
  • Removing out-of-date documents from circulation.
  • Controlling external documents.

• Risk Management

  Risk management is a pivotal area of focus for quality management. Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. After the FDA harmonizes 21 CFR Part 820 and ISO 13485, there will be a higher emphasis on risk management in medical device manufacturing. For compliance with ISO 13485, you must:

  • Apply risk management measures to new product development, design change, manufacturing, CAPA, and postmarket surveillance.
  • Complete a risk assessment and analysis of all QMS processes, including outsourced processes.
  • Engage in risk control, which includes decisions to reduce or accept risks.
  • Create and maintain records of all risk management activities.

• Equipment Maintenance

  Medical device companies are obligated to ensure that all equipment used in the manufacturing process meets specified requirements for equipment maintenance, adjustment, cleaning, and use. To comply with ISO 13485, companies need to:

  • Schedule and perform routine tests, calibrations, and maintenance.
  • Record and post notices of allowable deviations near equipment.
  • Document all equipment maintenance activities.

• Design Control

  The design control element of ISO 13485 requires companies to ensure that finished products are always designed and assembled according to the specified user needs and engineering requirements. Design controls require you to continually check your designs against requirements at each stage of product development. They should also prevent omissions and mistakes in device manufacturing. Managing design controls includes:

  • Documenting your design and development plan.
  • Maintaining an audit-ready design history file (DHF).
  • Ensuring product quality and compliance throughout the product's life cycle.

Simplifying ISO 13485 Compliance With Modern Digital Tools

Deploying a connected manufacturing and quality management sIndustry 4.0 initiatives and digital transformation efforts are in full swing throughout the medical device sector. Ongoing advances in Industrial Internet of Things (IIoT), artificial intelligence (AI), and robotic process automation are impacting everything from product assembly and quality inspection to equipment maintenance and GMP documentation. Advanced digital technologies like MasterControl's QMS and manufacturing execution system (MES) software solutions help medical device companies achieve comprehensive ISO compliance management.

• Reliable Document Control

  Effective document control is critical for maintaining medical device regulatory compliance. Digitizing document control processes facilitates medical device compliance by eliminating labor-intensive tasks such as the physical routing of documents for approval, distribution, storage, and archiving. An effective document control solution should have the following capabilities:

  • Collaborative workspace.
  • Revision control.
  • Secure architecture.
  • Part of an integrated platform.

• Effective Risk Management

  Risk management is pivotal to quality. It must be integrated into all areas of the company by effectively aligning people, processes, and technology and give all stakeholders access to data in real time. It helps to employ a digitally connected, data-driven approach to monitoring trends and identifying and mitigating risks before they result in costly delays, rework, or product recalls. A connected, end-to-end solution gives you:

  • A methodical approach to determining and managing risk.
  • The ability to track and analyze the recurrence of issues, which streamlines your ability to foresee and mitigate systemic risks long term.
  • Unified processes to manage risk-related activities and documentation.

• Equipment Maintenance

  Equipment that is poorly maintained or out of calibration can lead to a faulty product. Digitizing equipment maintenance is essential to complying with the equipment maintenance and calibration requirements of ISO 13485. A digitized equipment maintenance solution:

  • Automatically manages maintenance and creates tasks before maintenance is due.
  • Proactively tracks and monitors equipment maintenance to prevent unplanned outages.
  • Generates reports of maintenance and calibration activities.

• Design Control

  Digitizing design control streamlines processes and helps ensure medical device regulatory compliance. The platform approach to quality and manufacturing integrates design control with your other enterprise systems, including ERP, supervisory control and data acquisition (SCADA), laboratory information management system (LIMS), QMS, etc. A digitally connected design control solution:

  • Uses electronic file structure functionality.
  • Maintains all documents in the DHF in a single location.
  • Automatically tracks revisions and creates audit trails.

ISO 14971:2019 is a globally recognized standard to help medical device manufacturers apply risk management principles to their processes. The standard doesn't try to define what acceptable levels of risk are in a business, but lays out the process for identifying, controlling, and monitoring risks. Risk management needs to continue throughout the life cycle of a device, not just during design or manufacture. It should be revisited to take into account information gathered since the release of the device.

The following sections detail the requirements for a risk management system, per ISO 14971.

• Risk Analysis

  Risk analysis includes intended use and reasonably foreseeable misuse, characteristics related to safety, identification of hazards and hazardous situations, and risk estimation. The risk analysis and its results must be recorded in the risk management file.

• Risk Evaluation

  Identified hazardous situations are evaluated for risk and whether that risk is acceptable, per the risk management plan. Acceptable risk can be treated as residual risk. Otherwise, risk control measures need to be implemented. The risk evaluation must be recorded in the risk management file.

• Risk Control

  Risk control is meant to reduce risk to an acceptable level. This can involve building safety features into the device and/ or including safety information for end users. Manufacturers need to verify each risk control measure, which must be recorded in the risk management file. Residual risk then needs to be evaluated and if it is not acceptable under the risk management plan, a benefit-risk analysis needs to be performed. It's important to recognize that risk control may introduce new risks that need to be evaluated.

• Evaluation of Overall Residual Risk

  Similar to the residual risk analysis mentioned above, this evaluation is a look at the entirety of residual risk, not just that related to a specific hazard. If the residual risk is acceptable, the manufacturer needs to inform end users and record the results in the risk management file.

• Risk Management Review

  The risk management plan and its execution are reviewed before commercial distribution of the medical device. This review ensures the plan was appropriately carried out, residual risks are acceptable, and measures are in place to collect information in the production and post-production phases. Results of the review are included in the risk management file.

• Production and Post-Production Activities

  The manufacturer collects information during production and post-production, reviewing the information to determine if there is an effect on safety. If there is a potential risk, the manufacturer reviews the risk management file to determine if more action is needed.

Simplifying ISO 14971:2019 Compliance With Modern Digital Tools

Compliance with ISO 14971 relies heavily on the risk management file. Where ISO 14971 doesn't specifically mention the risk management file, it mentions documentation. A comprehensive document management system like the solution offered by MasterControl is critical for creating, approving, and keeping track of all the documents demonstrating thorough ISO compliance management. Below are just a few of the many benefits you can get by using a purpose-built digital solution to manage your compliance efforts.

• Create and Approve Online

  Getting together everyone that needs to be involved in the risk management discussion is hard, as is collaborating with them. A digital system lets you do all this online, giving people the flexibility to give input when they can rather than looking for a blank hour in everyone's schedule for a meeting.

• Version Control

  Risk management isn't meant to be a static system. ISO 14971 requires a life cycle approach, meaning this isn't a one-time process. Throughout risk management, documents will be updated, and old versions need to be archived. A digital system can ensure only the newest approved versions are accessible.

• Incorporation Into the QMS

  ISO doesn't require manufacturers to have a QMS for ISO 14971 compliance because a QMS isn't required by every regulatory body. However, ISO 14971 can easily be incorporated into a QMS for manufacturers that have one. This is further simplified if you use a digital QMS that has robust document management capabilities.

• Single Source of Truth for Risk

  Effectively managing risk requires that everyone measure risk the same way and use the same definition for acceptable risk. When this information is kept on physical documents, it's hard to ensure everyone can access it. A digital system designed for medical device regulatory compliance gives access to everyone who needs it and ensures version control.

• Audit Readiness

  The risk management file needs to be easily accessible during an audit and employees need to know they have the complete, up-to-date documents. A digital system greatly simplifies passing an audit, particularly if the system is part of a larger QMS that offers audit management functionality.

The perception that introducing a new QMS or MES can cost too much or disrupt operations too much shouldn't stop medical device organizations from taking steps to achieve a digital transformation that can dramatically reduce compliance burdens. It doesn't have to be a daunting undertaking that's done all at once. The key to success with digitally mature compliance processes is taking an iterative approach and having departments in lockstep in each phase.

Small steps toward digital maturity are easier to take when medical device companies have seamless integration between quality and manufacturing solutions. Having a common platform that unites quality and manufacturing teams enables them to work together to streamline digitalization across their shared processes, shared workflows, shared data visibility, shared training platform for compliance, and much more.

With MasterControl quality management system (QMS) and manufacturing execution system (MES) software, you never have to sacrifice compliance to achieve efficiency. Our solutions are designed to ensure compliance with regulatory requirements while also increasing operational efficiency. By natively connecting quality and manufacturing data in one powerful digital tool, MasterControl enhances data connectivity and provides real-time visibility into processes across the entire life cycle of your life-changing products.