Control in an automated environment

WHITEPAPER Managing Your Medical Device Master Files and Records Control in an automated environment Introduction In today s age of Globalization and cut-throat competition, it has become competitive necessity for Manufacturers to leverage teams that located across geographies you may have your design team in the US, your engineering team in India, your manufacturing team in China, and quality team in Germany. With such a geographically dispersed team, with each creating and storing their own set of files with different information, it has become increasingly difficult to find right information at the right time. On the other hand, increased regulatory pressure, especially on regulated industries, 01

has mandated organizations to ensure compliance with a set of standards or regulations key to which is having well documented, objective evidence. This means organizations must have the ability to access all key data elements that are captured within different processes and link them not only to particular documents but also to specific and relevant sections within those documents. A proper compliance control and document management system, thus, needs to provide the compliance department of any organization with the required system of evidence that is necessary for audit defense. At first thought, it might appear that most organizations in regulated industries would have functional document management systems that should be able to do this. The reality, however, is far from this. Compliance document management often remains highly silo-ed and fragmented, with most organizations not knowing what documents exist within their walls and/or where they are stored. Complications exist in this process in many forms. Manufacturing and medical devices companies, for example, have numerous drawings, notes, papers, and collaborative pieces created during the design process. Audits that may come years down the line may need you to access some of these documents. What are the chances of retrieval of such documents and any related information quickly especially if you have volumes in a paper based system? Not a lot! Medical device manufacturers make use of some of the most advanced technology of the day to make devices that work with magical precision, in comparison the systems used for managing documentation seem a bit antiquated. Many of them cling to paper and manual ways of documentation, often citing the fear of violations arising from any change to existing ways of working. However, in the process, they end up causing significant productivity losses and introduce other inefficiencies into their business. When audits happen, they have to dig into stacks of manual binders to retrieve the information that is being asked for by the auditor. The more the delay and difficulties in retrieval of this information, the lesser is the auditor s confidence in the business. This can end up lengthening the auditor s list of requests. Challenges in manual record keeping Having a paper based system of document management creates more problems for the organization than it solves, and the number of problems go on increasing longer the document needs to be stored and accessed. A new product, in medical device manufacturing, for example, can take anywhere between 1 year and 5 years to develop. It is important for the manufacturer to maintain the various files associated with product development like Design History File (DHF), Design Master Record (DMR) and Device History Record (DHR), among many other critical documents. These documents need to be accessed by the product engineers and manufacturing for their internal use as well as it is imperative to have them in proper order and readily available for external audits. Difficult to get the right information at the right time The sheer volumes of documents created over the product development period makes it very difficult to track all of them over lab notebooks, internal memos, emails, and documents stored at various physical locations. Paper based systems create huge inefficiencies in the process as they make it difficult to find the right information quickly. It becomes very difficult to maintain the different versions of the same document. It is important that everyone works on the latest version of the document with all the edits and reviews incorporated. The paper based document management system also creates storage and safety issues in the office. 02

Lack of smooth flow of information between Engineering and Production In today s world where speed-to-market is one of the highest priorities for top Executives, a perfectly harmonized flow of information between Engineering and Production (or Manufacturing) is a must for a successful product launch. A master document captures this information in the form of product specifications, and Production must, at all times, have access to latest version of it. As product specifications can go through a lot of changes, a lack of control for these Master documents can cause issues in production. If Engineering and Production are not looking at the same version of the Master document, or if Engineering does not capture changes to product specifications in the correct version, there will exist an information gap between design engineering and manufacturing teams. In a manufacturing process this could cause catastrophic failures when the product is released for production such as faulty design, deviations in manufacturing and clinical processes, inconsistent raw materials and parts etc. It is very important that the production and quality teams are able to share and collaborate on all the product related documents to ensure the product is a success, and to avoid product defects which, if found too late, can be costly such as resulting in recalls. Delays in internal reviews and approvals The product reviews in the manufacturing industry, especially in regulated fields like medical devices, are very stringent. Each of the document needs to signed and approved and only then the team can move to next phase. In a paper based environment it becomes a nightmare just to collect all the documents like design history file, design master record, device history record etc. at the same place. The information may be stored in too many different pieces, in too many different locations and in too many different versions. The team needs to collect and consolidate all the documents and then ensure that all these documents contain all the relevant and needed information. Each of these documents then needs to be sent for approvals to multiple top executives. Multiple follow-ups are done to get all the approvals which are finally recorded and saved. This entire process causes a lot of delay in the review process. Noncompliance in external audits Manufacturing firms have to undergo different types of external audits like ISO or U.S. Food and Drug Administration (FDA). It is imperative for the firm to always be ready for an audit. When an audit happens the inspector can ask for any file or document related to the design and development of any of the products of the firm. It becomes very difficult to find the right file when needed and it becomes even worse when the file has some information or approvals missing. The product development might sometime take over five years and this makes it even more difficult to provide old files for the audit. The challenge is even greater for the companies operating in multiple countries. Different regions across the globe have different regulators, each with their own requirements and specifications. The FDA s design control requirements in the US are significantly different from the technical dossier required to obtain a CE Mark in Europe and Shonin (pre-market approval) in Japan. For both Europe and Japan, regulatory requirements and audits are based on ISO 13485 standards. Hence the manufacturer needs to maintain different files for satisfying different audit requirements for different regulators. Difficult to make post market changes After a product gets all the approvals and is finally launched in the market all its related documents are stored in a document control 03

room, but the lifecycle of the product documents does not end with the product launch. A product undergoes multiple changes and iterations over its lifetime. There may be some complaints or nonconformance that would necessitate a change in the product. There will be corrective and preventive actions (CAPA) for improving the product. There may be another version launched with more functions and improvements. For each of these iterations the team will have to go back to the original design documents. In case the team involved in the original design is no longer there it becomes all the more difficult to find the relevant design and development documents for the product as the new team is not aware of what documents to look for. Hence, every time a change is needed in the product, a lot of time a nd resources are wasted in finding the right documents, making the changes and then refiling them. Due to all the above challenges, the Manufacturers today have realized that a paper based system will not suffice in an environment where products are becoming increasingly complex and audit requirements are getting more and more stringent. They have realized the importance of consolidation of all files making up a Master Record to be in one place, so that when a change does take place, anybody using the Master document will have the latest version. And that is the key value proposition of an Electronic Binder. Keeping the Master Record together As teams collaborate across geographies, and as the world itself becomes increasingly digital, the importance leveraging digital tools and platforms for managing large amounts of information in a logical and efficient manner, cannot be emphasized enough. And especially regulated industries, such as medical device and equipment manufacturing, can t afford aversion to digital information management. Let us take the example of documenting the design and development of a medical device. The complete documentation of this development is referred to as the Design History File (DHF). FDA requires you to give it to them as a proof that you have followed all the prescribed design control regulations. It is a must to clear all audits. As a central hub for compliance in the design process, DHF allows you traceability of all design controls and shows the relationships and linkages between the various design controls. Using digital means of information management, such as an Electronic Binder, for managing DHF gives you multiple benefits like having complete revision control, automating the routing of documents in a secure manner and having complete audit trails. Electronic Binders Quick access to any document Quickly add documents in various formats, including web content Connect documents with each other View and search documents Support for scanning paper based documents directly into the binder Rearrange the documents on the go Make better sense of data by adding notes, underlining, highlighting, etc. Better version control of documents Reduced cycle time for design completion Complete and accurate audit trail Automated CR management And much more! Electronic binders are collections of electronic documents. One electronic document can exist in multiple binders. You can create private binders as well as share them with designated team members. They allow multiple people access across geographic locations and also allow you to 04

quickly change who has access and what permissions they have. Unlike physical binders, there is no fear of any confidentiality breaches occurring due to the binders getting left somewhere or falling into the wrong hands since there are enough security features built in. Electronic binders serve to keep together master data files and information from multiple documents, much like traditional ring binders help store and organize paper documents. They help maintain all the relevant information with the latest version of the source documents. They also allow for collaboration, for example, between employees focused on different areas of a master file. Needless to say, not only do the Electronic Binders save you time and money (in terms of print, paper, and postage cost), they also increase productivity and improve communication among the different stakeholders. system is its inability to trace a problem for a particular product back to its source. In today s age of distributed manufacturing, records are highly relational and often comprise of a whole bunch of associated data and files it can be a paper nightmare taking hours, days or sometimes weeks to figure out at which stage of the product lifecycle did the error creep into the final design. Heightened regulatory requirements further necessitate organizations to maintain a properly tracked link between all design reworks, components, illustrations etc. within the Device Master Records and Design History Files for each product. This integration is nigh impossible to achieve with Document Control systems based on spreadsheets, network folders, or paper based systems. Electronic binders are not restricted to any one particular stage of the product life cycle. They can be used across the life cycle and help maintain a complete audit trail of what happened to the product based on the control of master document/files throughout the product development process of the medical devices. Now, who wouldn t like that! Integration with other downstream processes Paper based documents typically do not include all vital information, and typically will not take into account items such as nonconformances, actions taken against a SCAR (Supplier Corrective Action Requests), corrective and preventive actions (CAPAs), complaints, etc., thereby limiting their efficacy for downstream processes, such as the Quality Management processes. Another challenge with a paper based 05

Benefits of connecting Quality Data with Document Control Connecting Quality data with Master Files not only facilitates easier search and traceability, but also the identification of the root cause of issues. In a paper based environment, a change requested in the design/specification of a device often results in a complex Change Management process, which in itself is often a manual and time-consuming process that needs to be documented in an altogether different system often de-coupled from the actual product. If a mistake is made in managing this Change Request, thus resulting in an error in the final product design, it will be very difficult to pin-point this error by looking at the product history alone. Most Electronic Binders support a feature to electronically rout Change Requests to relevant product, and record the trail for this change. This not only provides an accurate trace back to a specific Change Request, thereby pin-pointing the root cause, but also helps in greatly reducing the Change Management cycle time. In order to obtain an FDA approval, manufacturers of Medical Devices need to maintain a record of all changes made to the design of the said device. These changes must then be made available to various stakeholder, including operations teams, design partners, quality teams, outsourcing vendors, and material suppliers in real-time to ensure one single version of the truth. While everyone remembers to get proper approval from a competent authority on these changes, ensuring that changes are well documented, validated, and maintained for traceability is where slip ups often happen standalone, spreadsheet based trackers can just not accomplish this task. An automated system will not only can significantly transform the operations by reducing time taken for conducting internal and external audits, decreasing risk of product recalls, improving product quality and safety, and thereby ensuring FDA and ISO compliance. Conclusion As with any other organization, prime focus of the manufacturers of Medical Devices should be on developing the core competencies, and that is where the day-today operations should concentrate their efforts. Inefficient and ineffective paper master files and records not only drain resources from critical operational activities to cope with the pains of managing mountain load of files, but they also jeopardize the reputation, and even existence, of the organizations by putting at risk the capability to meet with compliance requirements. The ultimate goal of the Document Control department should be to ensure that the master files and records are accurate, current, and easy to maintain, while the internal dynamics of maintaining the trail of document change should be better left to an automated system, such as an electronic binder which will not only result in reduced time to find information and a better traceability, but can also enable anytime, anywhere access to information, and can greatly simplify audit defense to regulatory inspector. Electronic documentation has been in existence for many years now and even FDA guidelines for the same have been in existence for over two decades. Today s Document Management tools have come a long way from the early word processing tools that came in existence with the advent of personal computers in the late 1980s. In the last 30 years, these tools have become much more powerful offering many features like versioning, automated reporting, traceability etc. The technology available in the market for electronic documentation and retrieval has thus evolved highly over the years. It is high time medical device 06

manufacturers evolve too, and embrace the electronic ways of controlling documentation. About the Author Govardhan Muralidhar brings more than 15 years of extensive experience in the design, development and deployment of enterprise quality and compliance management solutions across manufacturing, life sciences and regulated industries. He has worked with over 200 clients for the deployment of either on-premise or cloud based QMS solutions. Gova is currently a passionate Customer Success Ambassador at ComplianceQuest, the leading EQMS solution on the Salesforce platform. About ComplianceQuest The vision at ComplianceQuest is to transform quality and compliance into a strategic advantage for our customers through experience, expertise and passion. ComplianceQuest is an innovative, 100% cloud based Enterprise Quality Management System solution company. We provide an enterprise grade solution that streamlines quality, compliance, content and collaboration management initiatives and strategies across diverse, globally based supply chain networks. For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today. Visit www.compliancequest.com Email us at info@compliancequest.com Call us at 408-458-8343 ComplianceQuest LLC 07