Improving Regulatory Data Quality and User Adoption
Regulatory compliance is essential for any life science company’s survival and growth. To optimize operations, more companies are simplifying and digitizing processes and data, implementing cloud-based digital technologies for regulatory information management (RIM), and improving connections between regulatory teams and their clinical, manufacturing, safety, and quality counterparts.
Along the way, many companies are learning that even the best technology and most efficient approaches won’t improve operations if users aren’t convinced that these changes add value. Change management and user engagement are crucial to successful RIM modernization. Senior leaders from top 20 pharma companies recently met in a Veeva hosted roundtable to share best practices for encouraging adoption of RIM technology by users at all organizational levels.
Centralized data, entered locally: Driving data ownership and increasing real-time access
Cloud-based RIM is enabling a mindset change from the traditional approach of having a central data management team that enters and manages regulatory data. This traditional approach not only requires too many people but also increases the time lag for data capture, impeding real-time collaboration and reducing business process efficiency.
At the roundtable, regulatory leaders concurred on the emerging philosophy that RIM is the keeper but not the owner of all regulatory information. Even if data is centralized in a unified cloud-based RIM system, the task of entering key data must now be handled by those who are closest to the data including country managers, affiliates, manufacturing, CMC, or clinical functions.
Bringing data entry closer to the source of data enhances overall process transparency, creates data ownership, and establishes standard workflows across the global organization. However, it requires trust and comfort with a new process that eliminates traditional spreadsheet trackers and data update request tools. It also requires discipline about entering data once, on time, and at source every time.
Going beyond the term ‘data entry’: The right training and communication strategy
On the most basic level, attendees suggested, the industry needs to get beyond the term ‘data entry,’ which conjures images of dull grunt work. The effort must be shared and connected to a much bigger picture — not just by demonstrating the cost and time savings that new approaches enable, but by focusing on their positive impact on patients and the company. At some companies, appealing to empathy for patients (including patients who may be colleagues within the company) by pointing out how timely data entry at the source directly impacts people you know is yielding positive results.
Training programs are also being improved to allow employees to develop their own curricula based on their needs and learning preferences. More companies, for example, are using contextual data-entry screens that pop up while employees are entering information, to help reduce confusion and reduce errors. Others are making resources available, including user guides, SOPs, manuals, and videos via a personalized dashboard.
But digitizing training has not eliminated the human touch. Trainers and coaches are also being recruited to win over hearts and minds, scheduling regular office hours to handle employee questions and share Vault RIM best practices. One company has assigned regional field representatives in each local office for this purpose, while others have hired coaches with experience using Veeva Vault RIM at other companies, to help employees address challenges. This approach also reinforces the fact that the industry is adopting newer approaches, which can reduce resistance to change.
Another approach is to communicate the importance and urgency of data quality by means that go beyond email and other typical communication approaches. To overcome email-blast fatigue and create excitement for something as mundane as data quality, one company has implemented a “Data Quality Question of the Week” challenge, thereby reinforcing key concepts and increasing employee interest.
Carrot vs. stick: A spectrum of change management approaches
As with any new initiative, companies can take a carrot-or-stick approach to motivating employees. The ‘stick’ approaches discussed at the meeting make it easier for teams to use new processes and tools. For example, some companies have designed data entry user interfaces so that required information is mandatory, and documentation cannot proceed until it is entered. This approach leaves out optional information but ensures that essential information is documented every time.
Along with these practices have come mandatory data-entry meetings, designed to ensure that data owners and managers complete requirements by the end of each week. Instead of being onerous, the meetings have spurred friendly competition across regions and product lines and improved collaboration and communication between different global teams.
As another example of a ‘stick’ approach, companies are encouraging senior executives to look for information themselves within the RIM system, which, in turn, motivates employees to keep information up to date. This approach of live data-based conversations instead of reviewing prepared presentations during leadership review puts the spotlight on the entire organization – If data is not in the system, then the work is not done. An increasing number of companies are also encouraging quality departments to use regulatory data for supply release, which can reduce the time used to replicate that data internally.
Companies taking the ‘carrot’ approach are focusing on incentives based on data quality KPIs and goals. Employees who meet or exceed goals are recognized or offered token rewards. In some cases, they are mentioned in employee communication media. Another ‘carrot’ to directly enter data in the global system instead of local spreadsheets or data request tools is the savings achieved by decommissioning these older locally managed technologies.
Celebrating performance improvements is an important part of encouraging employees to accept new processes and workflows. In one case, using the new approach enabled a company to send regulatory reports to health agency inspectors sooner than had been possible in the past. To celebrate this achievement, the company published an article in internal communications media to recognize the team and the results of its work.
Prioritizing change management and data quality efforts
Implementing change management efforts to ensure data quality is time consuming, so organizations must continually assess the user groups and business processes that need attention. Some companies are using business process KPIs by regions and product lines to get a better idea of which affiliates and product teams are behind in entering data. Such business process mining enables data-driven decisions on where to target your change management effort. One company uses audit trail reports to identify the most heavily used screens of the system and prioritize the implementation of guided self-help or automated data quality checks. Overall, companies need to continuously monitor the impact of their change management efforts – to understand what’s working well and what is not.
To learn more about strategies for socializing change efforts and ultimately improving user adoption, read this infographic with tips from Agios, Intellia, and Turning Point Therapeutics, Inc., a Bristol Myers Squibb company.