Article
Published
8 May 2024
Veeva Vault is a cloud enterprise content management platform and applications suite specifically built for life sciences to bridge content gaps across the organisation.
Recently, Implement Consulting Group investigated how companies can maximise their investment in Veeva Vault based on market insights, deep dives with Veeva and analysis. Having been part of implementing Veeva Vault for many of our clients, we got curios about exploring this further.
In the last 5-8 years, many companies have chosen to invest in implementing Veeva Vault across one or more domains such as Clinical, Regulatory Affairs, Safety and Quality. However, some companies struggle to achieve the maximum value out of the continuous innovation and improvements you get access to when investing in Veeva.
Based on our study of both implementations and running customers, we see that organisations do not necessarily find it difficult to figure out what to do. Rather, they have difficulties figuring out how to do it and succeed with changing their company’s perspective and ability to enable continuous improvement and value realisation.
Changing processes and roles as part of implementing Veeva
Implementing Veeva is not just about technology …
… it is about how technology connects to data, processes and roles. A Veeva Vault implementation often spans multiple functional areas, processes and roles that have historically been siloed and will become interconnected down to the data and technology level. This means that organisations need a specific focus to ensure successful adoption and benefits realisation after the actual implementation.
Barriers for maximising the value of an investment in Veeva Vault
(Examples)
In our study, we found that there were three primary barriers to realising the full business potential via integrated processes and roles, although the overall commitment to implementing Veeva Vault is high in the organisation.
Trust
While people like the new technology, trust between different functions and divisions are often low. Having worked separately for a long time with high responsibility for own processes means that working across the value chain may raise concerns about quality issues and whether tasks can be performed in the right way/how it is normally done.
Silo-based leadership
The root cause for missing trust across functions/divisions can often be found in the leadership setup, which has historically been siloed in separate divisions and VP areas with clear segregation of duties between Clinical, Regulatory Affairs and Safety. While collaboration inside the functions can be high, the touchpoints between them have been few and, to a high degree, manual, human-driven interfaces and handovers.
Value chain-driven vs functional-driven
Implementing Veeva Vault necessitates shifting the paradigm to thinking more holistically, not just across the company and its function but the entire ecosystem that a life science company operates in with CMOs, CDMOs, CROs, hospitals and more. This means that a much more value-driven perspective is needed, which is not something that is easily embedded and adopted as part of the technical implementation. Rather, it is something that must be understood, accepted and worked on from top to bottom in the organisation. Otherwise, the risk is that, as a company, processes and roles are systemically and technically becoming connected, while the overall leadership and high-level processes are not, which basically results in a short circuit and bottom-up harmonisation and standardisation without clear mandate or guidance.
Key focus areas for success
To increase the likelihood of success of changing processes and roles as part of the Veeva Vault implementation project, we see the following key focus areas as a common denominator.
Clear impact and benefit case
Having a clear impact case and benefit case is directly correlated with succeeding with implementing Veeva Vault. Establishing a clear project vision early on, coupling that to which business and behavioural impacts are needed to be successful, will shift the focus from technical integrations to business success. Analysing and understanding how the project vision impacts the individuals’ roles, processes and data changes are crucial to ensure everyone is onboard, and that business objectives drive the desired change.
Process sponsorship
Nominate a process sponsor as high up in the organisation as possible who owns the process harmonisation and services as the point of escalation to clarify and decide which behavioural changes are needed to achieve the desired business impact. This person should have the wide perspective on processes (level 1-3) and not just the processes being configured in the system (level 4-5). This ensures that the holistic perspective is taken and that the cross-organisational benefits and opportunities are realised without drowning in political discussions or inability to move due to solutions being found in the crossing between functions and thereby without a clear owner with the mandate to make a decision.
Invest in continuous organisational change management (OCM)
While OCM should not be a surprise to anyone running IT projects in modern times, underinvestment in this area is still a huge issue. Hard and tangible disciplines like test, validation, technical integrations and data migrations receive the main attention – and budget – while only very few organisations invest in OCM on equal terms. This means that the organisation is often left to its own devices and has to do with newsletters, intranet articles and the minimum training required.
Studies show that 87%1 of projects succeed, up from 26%2, by focusing on designing and driving the change based on impact, flow and leadership. Taking change management serious ensures deep leadership commitment, enable engagement from the organisation, base all communication efforts on simple key messages that are understandable and appealing to end users and, most importantly, focus on the changing ways of working to achieve the business and behavioural impact we look for. All of this by embracing the technology change but focusing on the employees’ day-to-day job and how to improve it.
Ensuring continuous improvement
One of the main arguments for investing in Veeva Vault is getting access to a cycle of constant innovation based on the three annual releases consisting of small corrections and additions as well as functionalities that have the potential to improve business processes. This is one of the most demanded changes but also one of the hardest things to get right.
In the “old world” based on on-premise IT systems, the goal was often to implement as close to 100% of the requirements as possible and then keep the system stable after go-live. This meant that businesspeople were needed to a lesser degree to maintain the system until a larger update of the system would be available in years 3-5. The running organisation would, therefore, be IT-focused to maintain the full stack from hardware to OS and the application itself, ensuring security patching, bug fixes and the associated validation and test.
Veeva Vault, being 100% multitenant cloud-based, does not require any maintenance from the hardware to the application level, as this is maintained by Veeva. Instead, the focus is on the configuration itself and the continuous features being released. While it may seem logical that this requires a different approach than previously, this is often where the wrong approach is taken, and instead of embracing changes, companies end up with “innovation stress” – only implementing mandatory updates and leaving out optional upgrades which could significantly improve the business processes.
Example
Collaborative authoring in Microsoft Office was introduced in 20193 in Word and in 2020 with Excel and PowerPoint. In several processes, e.g. when you do submissions in Regulatory Affairs, collaborative authoring can be a significant time saver, eliminating locked documents, allowing everyone to work efficiently on their individual sections, potentially shaving off valuable time and enabling you to submit as early as possible. In 2024, many companies have yet to implement this feature, even though, technically, the update is minor.
Typical pitfalls
- Failing to adjust the resources
Previously, the mix between IT and business was ~80/20% split. Some companies proceed with a primary involvement of IT, meaning that evaluation of features relevant to business is not being done appropriately nor with the involvement of business, thereby removing the opportunity to continuously improve the business processes. - Trying to fight the release schedule
With an on-premise solution, it may have been a measure of success to approach the release schedule as something to spend as little time as possible working on and rate success as keeping the solution as stable as possible. However, this defeats the purpose of being on Veeva Vault. - Not managing the backlog
While releases will contain auto-on and auto-off features, it does not mean that auto-off features can be ignored. One thing is missing out on the business potential, but auto-off features may also become mandatory over a period of time. By not managing the backlog properly, companies can get unwanted surprises, as functionality introduced many releases back become mandatory.
What will it require to succeed?
Keep focus on the impact case. Going live does not mean removing focus from the impact and business case. It should be used as an instrument for continuously guiding the benefits realisation and maximisation, keeping it alive and relevant and focusing on how it trickles from the vision to business and behavioural impact.
Staff right. Get business involved properly, realise that the right split may be closer to 40% IT and 60% business and make sure that the business involvement is part of their job and not a responsibility on top of the day-to-day business. However, make sure not to remove businesspeople from the operations; otherwise, they will lose their insights into what matters over time. Keep senior leadership involved throughout. They are not sponsors for the implementation but for the product delivered after go-live.
Design for change. Introduce KBIs – key business indicators – that motivate change and are green when changes are adopted. Put in place a centre of excellence (CoE) with the right people and the purpose of continuously keeping the system validated throughout the release cycles, but more importantly, ensuring that high-value auto-off features are planned and implemented to maximise business benefits. Ensure that they work across business areas to optimise efforts and avoid any double work. Maintain a strict process and procedure for how to manage auto-on features to minimise the effort needed and stay ahead of the curve. Do an efficient management of the backlog of auto-off features with a set cycle for when, how and who to continuously re-evaluate.
But is it really that hard?
When implementing a solution like Veeva Vault, a lot of the changes needed are dealing with changing the ways of working and behaviour of the employees that are working with the system. So, while it may seem like common sense or logical to do the initiatives mentioned here, the hard part is getting your organisation, roles, processes and people to follow through. Furthermore, there are a lot of old habits and ways of working that need to be unlearnt before the full potential can be released.
Implement Consulting Group focuses exactly on delivering change with impact. We insist on understanding the desired impact: vision, business impact and behavioural impact so that we can engage and help you maximise your return on investment by ensuring that people get onboard, organisations change, silos are broken down, ways of working are re-designed and roles adapted. And that is the hard part. Technology and data are challenging, but getting people to change their ways of working is even harder. Engage with Implement whether you are standing in front of an implementation or have gone live but need an overhaul of your ways of working to ensure you get the best of your Veeva Vaults.
Sources
1 https://halfdoubleinstitute.org/about-half-double-institute
2 Jacquemont et al. (2015): "How to Beat the Transformation Odds"; (n=1713)
3 https://www.veeva.com/wp-content/uploads/2020/02/Vault-Collaborative-Authoring-FAQ.pdf
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