The Project: Implement a new tracking solution that could be put in place and ready for auditing within a very tight timeframe.
The Solution: Select a solutions provider that has experience in rolling out a compliant software system for life science companies.
Operating in 65 countries with a team of over 2,000 people, ResMed is focused on developing innovative therapies that increase patient comfort and convenience while improving health. A significant area of focus for ResMed is the development and manufacture of products for the screening, treatment, and long-term management of sleep-disordered breathing (SDB), a condition that affects around 20% of the adult population. In addition to providing new and innovative products, the company is committed to educating physicians and the public on the health consequences of untreated SDB through the ResMed Foundation.
|Blue Mountain's validation protocol provided the IQ and OQ scripts for the validation of the software.|
The ChallengeSince their products directly impact the health of their customers as well as their bottom line, ResMed takes quality issues seriously. As a medical device manufacturer in an FDA-regulated environment, ResMed develops processes and procedures, specifically calibration, according to the current Good Manufacturing Practices (cGMP). ResMed was aware of the potential impact of haphazard calibration and knew they had to dedicate resources towards calibration controls. They realized that their current in-house tracking system, however, no longer met the needs of their growing organization. With upcoming internal and external audits, ResMed had roughly six months to choose and implement an FDA-compliant computerized calibration management system (CCMS) at their Sydney, Australia facility. This facility manufactures masks and flow generators for SDB, encompasses 600+ employees, and covers 1.3 million square feet.
The SearchResMed was looking for a single solution to manage calibration at all their sites worldwide, beginning with the Sydney, Australia facility. The software would need to be able to track the 4,000+ instruments expected in the Sydney site and eventually handle the 10,000+ instruments worldwide, all within the same server implementation. Likewise, the selected software would have to permit a certain degree of configuration and flexibility to satisfy the unique business processes they had to follow at each of the individual facilities.
The search for a reliable and compliant CCMS began with the manufacturing and IT departments. ResMed evaluated three different options for a CCMS, including additional development of their current system. ResMed has an established project methodology process that allows them to evaluate their options and quickly discover what products will satisfy their requirements. After weighing the different options, the team leaders chose Calibration Manager from Blue Mountain Quality Resources. It not only had the features and flexibility to meet the growing needs of ResMed, but also the ability to maintain full compliance to FDA requirements. “It is the industry standard, FDA-compliant, and well proven,” said Vanessa Moopanar, Business Analyst.
The ImplementationImplementing any enterprise software system can be a daunting task. Often times, companies are lacking the resources to properly implement a CCMS. Even when companies have the people-power, pulling them off other projects and learning enough about the software to ensure its most effective use are difficult to achieve within a limited timeframe. If internal people are not familiar with the validation and documentation requirements for enterprise software, there are compliance risks. With these factors in mind, many companies are partnering with software vendors and other service providers to not only contain risks, but also to cut costs.
At ResMed, once the selection was complete, they immediately assembled a five-member team, consisting of IT, QA/QC, the lab manager and a project manager, to oversee the Calibration Manager project. The team quickly realized that they did not have the available resources and expertise to implement and validate the system on their rigorous timeline and therefore decided to look for a trustworthy partner to implement the CCMS.
ResMed’s chosen software vendor, Blue Mountain Quality Resources, offers turnkey implementation services designed to get the software up and running on tight schedules. Having performed well over 150 implementations and validations of Calibration Manager at regulated life science companies, Blue Mountain was just the partner they needed. They challenged Blue Mountain to install, configure, and validate the software within 61 days.
Blue Mountain followed a proven and structured approach for the project. With a firm understanding of the implementation and validation process, they determined where resources could be doubled up to speed up the process. During the course of the project, Blue Mountain had three different service professionals working in Sydney, with data migration and much of the project management handled off-site to reduce travel expenses.
One of the keys to a successful implementation and achieving the greatest return on investment lies in the time and effort invested in the planning stages. During the planning stages, everyone should be clear on the goals for the implementation and expectations for the system. Particularly when timeframes are short, it is also important early on to determine who needs to be involved at each stage of the process, to make sure people are available to share relevant information, to make decisions, and to get required signatures.
For ResMed, the planning stage also included training on the product for the core team. This gives these individuals a detailed understanding of the product and how the software can and should be configured to satisfy requirements and conform to existing procedures. After this training and consultation with the vendor, the team had a chance to evaluate existing procedures in light of the automation benefits provided by the software. For example, one of the key questions to be addressed during the planning phase is to decide on a philosophy for paperless operations; how much does the team want to continue to rely on a paper trail versus the electronic record keeping of the database? ResMed’s software choice gave them the option to go completely paperless.
For ResMed, the deadline dictated the schedule, with a firm “go live” date. ResMed was able to quickly establish what they expected during the implementation process and from the software afterwards. While ResMed made sure the appropriate resources were available when needed, they relied on Blue Mountain to manage and drive the entire project.
Transferring data from one closed database to another, whether it is done manually or automated, is more complicated in a regulated environment where systems need to be validated. Although much more efficient and cost effective than manual entry, when using an automated process, multiple migrations are necessary to demonstrate that the process works and produces the expected results before the last migration is performed. ResMed’s migration of data from their old system to Calibration Manager was accomplished efficiently and effectively. Blue Mountain worked with ResMed to create system configuration and field mapping documents prior to the migration. Those documents outlined the set-up (e.g., field names, data set properties, etc) of Calibration Manager, as well as where the original data would appear in the new system. That organization and planning between both companies made the data migration successful.
The ValidationTo prove that a CCMS was implemented properly and is working as required and expected, the FDA requires that it be validated. They are looking for documentation that the system, as implemented, meets the user requirements specified in the company’s User Requirement Specification (URS) and the expectations established by the software vendor. Most companies have come to rely on the Good Automated Manufacturing Practice Guide (GAMP 4) published by ISPE as a detailed guide on how to satisfy the validation requirements. The validation of the system itself is broken into three steps:
Installation Qualification (IQ):Verifies that the software vendor’s design specifications were accurate and the execution of the installation occurred according to plan and expectations. This documentation includes the procedures for using the software, the hardware that the system runs on, the details of the software version, the actual installation, and the library of documentation that accompanies the software.
Operational Qualification (OQ):Verifies that the software functions according to the software vendor’s specifications. The OQ addresses the items listed in the Functional Specification and elements from the Design Specifications not covered in the IQ.
Performance Qualification (PQ):Verifies that the software meets the requirements and expectations established in the URS at the beginning of the selection process. While the first two steps are largely the same for all companies installing the software, the performance qualification is very specific to how the software is used and tests how it performs in that context.In the case of ResMed, with a tight deadline and limited internal resources, they relied on Blue Mountain for most of the validation effort. One area where they didn’t need help was the server and hardware qualification, which was already taken care of before the project began. Blue Mountain formalized the materials that ResMed had put together during the selection process to create the official URS, gap analysis, and traceability matrix documents that the FDA and other national regulatory agencies look for.
As a software vendor that focuses on solutions for life science companies, Blue Mountain offers a complete set of scripts for IQ and OQ validation of Calibration Manager. Generating these materials from scratch for software that has been internally developed or from a software vendor that does not often sell to life science companies can be a very time-consuming process. Without existing scripts, the completion of the project on schedule would have been in jeopardy.
The PQ scripts, being specific to ResMed’s precise uses, naturally had to be developed for them. Having been involved in the decision making on exactly how the software would be used, Blue Mountain was able to develop these scripts.
The validation scripts provide a concrete roadmap for exactly what to test in the software. During this process, screen captures are taken of the software to clearly demonstrate that the system is operating precisely as expected and needed within ResMed procedures.
Execution of the validation scripts was an area where Blue Mountain was able to put two service professionals on the same project at once. At other points in the process, it was possible for two individuals to work on different projects in parallel. Dedicating additional resources in parallel like this was the key to Blue Mountain’s ability to meet ResMed’s tight timeframe.
With upcoming audits, ResMed wanted to take no chances with the quality and completeness of the documentation, which is why they chose to partner with a company that had extensive experience in implementing and validating systems at regulated life science companies. They were impressed with the final documentation and felt confident heading into their audits.
The TrainingFDA-483 inspection reports have increasingly referenced the quality system regulation (QSR) stating that employees must have the appropriate “background, training, and experience” to perform their function within the organization. 21 CFR Part 820.25(b) states that “each manufacturer shall have sufficient personnel with the necessary education, background, training and experience to assure that all activities required by this part are correctly performed.”
ResMed understands the vital importance of training on a new software package that impacts compliance to regulations and the quality of a product. ResMed wanted to ensure proper training on Calibration Manager for its employees’ use and naturally insisted that it be included in the final turnkey implementation to be completed ahead of the audits.
Calibration Manager training was customized by roles, including Calibration Technician, Administrator, and Manager. This allowed each individual to learn how to utilize specific areas of the software that will be most beneficial to their position at ResMed. For example, the Calibration Technician focused on creating Measurement Data Templates and recording data, while the Administrator learned how to adjust the system configurations when changes occurred. With this experience, ResMed then continued in-house training twice a month to ensure people were using the software properly.
ConclusionBlue Mountain’s 61-day implementation not only allowed ResMed to get up and running quickly on Calibration Manager, but also gave them a model for other software implementations. “We had developed a process for software implementations a year ago. We are continuously improving it and now look at Blue Mountain’s implementation as a benchmark,” said Moopanar.
ResMed now has a validated system for calibration management with the confidence that they have the system and documentation in place to pass future audits. Information is no longer passed along through “offline” means. Systems and processes are now in place that will improve productivity and manage compliance. The purchase and implementation of Calibration Manager also raised the profile of calibration control throughout ResMed. People understand the implications of using non-calibrated and out-of-calibration equipment.
ResMed continually evaluates ways to get more from their Calibration Manager investment. They have an individual in Sydney responsible for evaluating the system for features they may not be using fully and new ways to extend the features they are using.One of the deciding factors for ResMed in their purchase of Calibration Manager was its having been designed to be implemented at multiple sites. The software’s web-based and n-Tiered architecture greatly enhances the system’s performance and simplifies the sharing of a single implementation (and single validation) across multiple sites. The software accommodates different configurations and settings at multiple sites by separating the data into unique “datasets”. With the Calibration Manager’s multi-site capabilities, ResMed’s next implementation project will be to expand the use of the software into their other global facilities, a relatively easy matter with the groundwork established in Sydney.