Manufacturers of medical devices are among the most highly regulated and most thoroughly equipped companies. They invest enormous sums of capital in business, research and manufacturing assets ranging from clean rooms and data loggers to CAD software and programs for computational fluid dynamics. Yet even as medical device manufacturers leverage digitization for business and product development efficiency, many continue to rely on inefficient paper-bound processes to control product information, change record management and other data critical for compliance and audit success. The question is why?
The answer, in part, is that manufacturers fear electronic records management systems are complex, difficult-to-use platforms which could expose a company to regulatory failures and delay a product introduction. The paper-bound process, on the other hand, offers a time-tested and proven methodology, but it is a very slow and cumbersome way to do business. Urban legends of companies running into deep trouble trying to implement an elaborate — often homegrown — electronic records management system reinforce these beliefs.
The truth is, in an increasingly competitive marketplace, the efficiency and productivity gained by transitioning from paper-based change management to a modern electronic records management system cannot be ignored. Instant sharing of data with disbursed teams and suppliers as well as tightly controlled audit-ready data trails are just two compelling reasons to shift from paper to electronic processes. In this dispatch we examine some of the key issues that you need to consider to develop a successful plan for selecting and implementing an electronic records management system.
Organizing your electronic system with regulatory requirements in mind will prepare you for audit success.
Critical to the success of any medical device company is the ability to meet industry regulations and exceed the expectations of auditors. Switching from a paper-bound to an electronic records management system means that auditors will interact with your data in a new way — through your electronic system! In addition, new regulations to address electronic compliance requirements come into play. Organizing your electronic system with regulatory requirements in mind will prepare you for audit success.
The first step to putting in place an appropriate electronic records management system is understanding the compliance requirements that your company will face. To begin that process, consider carefully the type of products you produce and, using the United States for this example, their FDA classifications, Class I, II, or III. Then ask yourself a series of questions:
Your answers to these questions will lead you to the regulatory standards governing both your business practices and your product development. Medical device companies in the United States typically are governed by 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 11 (Electronic Signatures). Companies in the USA also frequently achieve certification under ISO 13485 (Quality Management System), especially those considering certification for their products in overseas markets.
What is needed to achieve specific compliance requirements is beyond the scope of this dispatch. But it is critical for you to consider how you will organize your data within your electronic records management system. Be certain that you are able to manage your quality system, product data or other relevant data to provide ready evidence of your business processes and standard operating procedures (SOPs) as required by the regulations governing your business. Consider how you will demonstrate to your auditor that your data is organized, accessible, and controlled. Be certain that you can prove access control, produce audit trails for changes to your documents and product records, and that you have met electronic signature requirements.
Your company may also be bound by international regulations in addition to US regulations. As in US markets, medical device companies selling product worldwide need to have an electronic records management system that enables visibility into company data in such a way that auditors’ questions are answered easily. Each overseas market that you sell into, however, has its own regulatory agency.
Medical devices sold in the European Union, for example, may be required to bear a CE certification mark. This certification is issued by a Notified Body, which is an organization within a member state of the European Union accredited for assessing that products meet standards. Medical products sold in Japan typically must meet standards set by Japan’s Pharmaceuticals and Medical Devices Agency. The Therapeutic Goods Administration regulates medical device certification for Australian markets, and on it goes.
Fortunately for companies already planning to receive ISO certification, many international regulatory agencies use ISO 13485 as a starting point and then extend it with additional monitoring, control and oversight they deem in their nation’s best interest. Consequently, much of the work required to meet ISO standards is applicable worldwide. The key to the correct selection of an electronic records management system is careful consideration of who your auditors are, where in the world they are, and what data they will want to see.
Typically, companies face a few hurdles in garnering organizational buy-in: lack of commitment, incomplete communication of the implementation plan, and ill-defined start dates.
You will waste all your work identifying the compliance requirements you must meet if you do not achieve a company-wide acceptance of your electronic records management system. It is critical to your success that all affected departments in your company embrace the use of the new electronic system and work diligently to adopt the new processes for optimal efficiency. Typically, companies face a few hurdles in garnering organizational buy-in: lack of commitment, incomplete communication of the implementation plan, and ill-defined start dates.
The importance of the full commitment of all parties who will interact with your new electronic records management system cannot be overstated. Simply having corporate executives make a proclamation and sign-off on the purchase order is not enough. Implementing a new system like electronic records management is as much a cultural reform as it is a technological undertaking, so staff must be engaged early and throughout the process so that they develop a personal stake in your new system. Answer the “What’s in it for me?” question from their viewpoint in the trenches to build up their trust in the change that is coming to their work.
Early discussions with departmental stakeholders to determine their specific requirements with respect to the new system will enable your staff to feel ownership of the new processes. Discover your staff’s pain points and discuss together how to cure them with specific features offered by the new system. Make sure that all the affected departments within your company have a say in which system to choose and how it will be implemented. Although it is impossible to please everyone all the time, asking your staff about their needs will greatly increase the chances both that you choose a system that will work for them and that they will adopt the system positively.
You may even wish to walk through particular key processes with your staff, mapping the requirements to the new steps in the electronic system. For example, have your staff train on the simple task of delivering a document to a disbursed team member. Have them record the steps they go through in the current paper-bound process, such as print out, sign and deliver the document to the mailroom, and wait 48 hours or so to re-commence their work. Then, compare the new process — digitally sign the document, target receives notification of the document automatically, target digitally signs and returns the document within minutes.
After setting the stage for company-wide acceptance of your new system, it’s essential that you fully communicate the roll out plan. This includes short-, mid-, and long-term implementation plans. Your employees should understand how all the pieces fit together to successfully achieve your overall business objective for your switch from paper-based to electronic records management.
What your company goals, small and large, are for adopting the new system
When each piece of the system will be implemented (quality, document control, product records, etc.)
What time and manpower has been allotted to them to perform the conversion
What milestones and metrics will be used to analyze the success of the conversion
Even though your employees may readily understand that an electronic records management system can enable them to do their jobs more easily and more efficiently, they still might be nervous about making the transition. By laying out the process clearly for them, you will minimize their uncertainties and enable them to feel more in control of the changeover.
Your employees should understand not only when the implementation process will take place, but also when it is scheduled to be completed. Most importantly, it should be abundantly clear when the old processes will cease to be used, and the new process will become the sole way of conducting business.
Failure to set a definitive cutover date is probably the most common reason conversion projects fall short, because this failure stems from fear of change. Letting go of the way you’ve done things “forever” is difficult to do, so often organizations try to use both the new and the old systems simultaneously. Often doing so is rationalized as a fail-safe system. But using both the old and the new processes simultaneously might more accurately be called a “sure-to-fail” system. Since only some of the data will be in electronic form, your total data portfolio will be out of sync and nearly impossible to correct. Early adopters and hold outs will eventually begin squabbling with each other over who is to blame for the confusion. The resulting chaos will fray nerves, cause delays, and lead to missed deadlines and cost overruns. At best, your investment in a new electronic records management system will languish in limbo for an extended period. At worst, you’ve wasted a lot of money when the conversion never fully occurs.
So, set a definitive cutover date and stick with it. Make sure that your staff receives a lot of training close to the switchover so that they are well prepared for the moment you go live with the new system. In addition, make sure that support is immediately available when that moment arrives. Give everyone cheat sheets and 800 number lifelines. Better, have super-trained colleagues from your business available to assist in the work area. They’ll be less threatening than strangers from your vendor, and can inexpensively augment any vendor experts. Finally, make certain to build a few days into your schedule to accommodate the inevitable short-term productivity dips that will happen.
Once you have obtained organizational buy-in, your third step is deciding what data will be controlled by your electronic records management system. This is not as daunting as it may sound. The key is to take the time to develop a step-by-step approach to transferring your processes to the electronic records management system while always keeping your eyes on your objectives.
Start with the data itself. Your company has reams of data. Your engineering group produces Device Master Records (DMRs) and Design History Files (DHFs), while your Quality team produces inspection reports and calibration logs. Your purchasing group tracks purchases, supplier information, and approved manufacturer lists. You also have quality documents, SOPs, test reports, design planning documents and meeting notes. Identify where all this data resides today. You may have it stored on a central file server or on individual workstations. You may even have file cabinets full of paper containing some of this data, and then other pieces of data cataloged in an ERP system or design database.
Begin your transition by porting to your electronic system one class of records that represents your smallest and cleanest dataset.
Begin your transition by porting to your electronic system one class of records that represents your smallest and cleanest dataset. For many companies, a good initial dataset is quality system documentation. Start with active data, and worry about legacy data later. Your objective here is to get the data into the electronic system and ready for productive use quickly. Record all the lessons you learn — such as how you discovered and repaired data inconsistencies — so that you can apply these lessons and newly imposed standards during conversion of subsequent record sets.
What information do you need to get out of your system for informed business and design decisions?
Do you need to capture approvals directly on documents or in metadata about the documents?
How do you mark-up, view, and track document annotations?
While all of these questions are important, the first is vital. Your product records need to mimic your design processes. Otherwise you cannot demonstrate to auditors your design history in a satisfactory manner. Make sure that your records include design review notes, change orders, and sign-offs.
Later, as your confidence and expertise builds, you can extend your electronic records management system. For example, you could add product record data, followed by complaint handling, then approved supplier information. The order in which you transition your business processes will depend on your company needs.
In addition to selecting what classes of data to include in your electronic records management system, it is critical that data produced by your business tools, design and process management solutions form a comprehensive system so nothing falls through the cracks. All your data, after all, needs to be documented and stored so that it can be leveraged to inform your design and purchasing decisions. As part of your selection and implementation process, you need to assess what data will remain in other specialized systems for tracking inventory, controlling clinical data, handling employee training, and the like — and how to link all that data into a cohesive data record that closes the loop on your product. Pay particular attention to how data will move from one tool to the next, and how data will remain synchronized. Your data integrity depends on all systems remaining both up to date and in agreement.
Once you have prepared and converted your data, trained your staff, and set a cutover date, you might think that you’ve done everything possible to ensure your success. Perhaps — but are you really sure of that? Take the time to do a final check.
One major goal that all medical device companies have in implementing an electronic records management system is to pass an audit more easily. Take a moment to reflect on how you implemented your new system. Based on your past experience, are you ready for an audit? By thinking through and performing an internal audit of your new system, you can correct any shortcomings right away. Before you have entered so much new data that you endanger your business down the road, walk yourself through the act of demonstrating your processes to an auditor. You might even want to make the mock audit a component of an extended staff training exercise so that your staff can really get to know how the system operates.
Start your audit with the obvious: Did auditors cite you for any weaknesses previously? Does your new system address those issues?
Next, ensure that your electronic processes records demonstrate your design phases and product design history in a way that satisfies auditors. Most importantly, make sure that you capture all the data. This means all data: change orders, work instructions, equipment specifications, and test reports as well as easy to forget things like the notes scribbled down at design review meetings.
Digital signature requirements are easy to overlook. Make sure that you have filed all the proper paperwork with the FDA and that in your employees’ personal records you have physically signed documents stating that they understand their digital signature responsibilities and authorizations.
Step through a mock design cycle. Stop frequently and verify that all data has been captured and indexed properly. Prove that event sign-offs happen when they are supposed to happen and how. Double-check digital authorizations and signatures with each staff member to ensure that the processes are properly set up. Check to see if an employee can digitally authorize something that, in reality, he or she is not authorized to do.
In short, be as hard on yourself during your mock audit as any auditor would be in real life. Consider hiring a team of retired auditors to help you do it right. Passing an audit is the key for success at medical device companies, and an electronic records management system should increase your confidence that you are ready to handle an audit. Doing a final spot check will assure you that your system is ready for action.
Selecting and implementing the right electronic records management solution is a key piece of building a well functioning system that minimizes errors, enhances efficiency, fosters collaboration and data sharing, makes you audit-ready, and provides a tool that enables data-informed business and design decisions.
A holistic assessment of the near- and long-term goals for your electronic records management system will help you select the right system that will scale with your company as it grows. Well thought out, step-by-step data conversions, implementation procedures, and cutover dates will help ensure a smooth transition to a new electronic records management system.
Follow the checklist on the bottom to plan for and implement your new electronic records management system successfully.
©2012 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. & Tm. Off. All rights reserved. Other product and company names are the property of their respective holders. Contact Arena at questions@arenasolutions.com for permission to repost or syndicate this content.
Ready to start? Try Arena free for 10 days. Sign up
