ALK transitions to the cloud with Veeva RIM Suite

Challenge

ALK's on-prem Regulatory system was inflexible, required many workarounds, and provided limited insights for the Regulatory Affairs department.

Outcome

Epista helped ALK bridge the gap from an on-prem system to the Veeva RIM Suite by using best practices suited to their needs and business processes.

Case

The Global Regulatory Affairs department at ALK provides the company with leadership and guidance on regulatory matters throughout the life cycle of a drug. They work closely with many stakeholders to influence governance and decision making.?

Over time, ALK found that their Regulatory system setup didn’t assist their efforts to achieve this mission. An EDMS system for proper management of submission documents was required, and even though their current RIMS (Regulatory Information Management System) for tracking was largely well-functioning, it was quite inflexible. “One of the main drivers for replacing the RIMS was the lack of flexible reporting functionality. We have a relatively complex product portfolio, and this downside was impacting us” explains Ida Bastian Brügger, Team Lead for Compliance and Operations in Global Regulatory Affairs at ALK.

Necessity became the mother of invention and they?came?up with creative workarounds?to the limitations of their RIMS. Ida says:?“We became masters of the ‘Remarks?Fields’. We invented?and documented?an entire?syntax?so that we could?use?free-text remarks?fields?to store?and extract?important?information?that didn't fit anywhere else in the system. Not an optimal setup!"

What's more, the system had many features that ALK didn't utilize, creating unnecessary complexity with?many?unused?window titles and tabs?that?they were unable to hide. "We had to write our way out of this?problem?with working instructions and guidance documents to?make sure?people were only using the parts?of the system they were supposed to use” continues Ida.?And often,?duplication of data?was required?to support the reporting functionality that delivered no additional?business value.

Finally,?because different areas of the business used individual,?siloed systems,?Regulatory Affairs had?limited insight into?what was going on in other areas.?They weren’t?looped into planning activities.?All in all, their?Regulatory?system?setup?no longer made good business sense.

So, they?decided?to move to a?unified platform that would?both?solve their?regulatory?challenges and?at the same time create value and?synergy for all areas of the company.?After investigation, they?decided that?Veeva’s RIM Vault?would create the most value for ALK.

Fact:?ALK established in 1923 | 2400 employees | Active in 41 markets

Getting Started

From the very beginning, Ida knew she would need?a service partner to?help?ALK?plan?the move to?the RIM Vault,?and?in particular Vault?Registrations. "This is all new for us.?Even with a?development?sandbox –?we couldn’t?establish?best practices?on our own. What’s standard functionality? What?needs to be configured? And so on. We have an awful?lot?of knowledge about our data,?and?the?Veeva?folks?are experts in their own?system. What we lacked was?business?processes?expertise. We needed?a?bridge?to take us from our current?system?to the new?one,?using best practices?suited to?ALK’s?specific?needs.”

Ida had?three?specific criteria?when selecting?a?service partner. First,?obviously, they?needed a strong knowledge of Veeva.?Second, they needed?to?have detailed knowledge of?ALK’s?current system. “We?didn’t want to?spend time and effort to?train a partner in our current system. We needed someone who?could tell us on?Day 1: 'OK,?because?your system is set up like this,?you should look at this specific?Veeva?functionality' Ida explains. Another reason this knowledge?of ALK’s current?system?was important?–?ALK’s subject matter experts?(SMEs)?‘speak the language’ of the current system.?If?the?service partner didn’t?also speak?that?language, communication with these SMEs?could be a?problem.?More on the SMEs and their role in the project, later.?And the final selection criteria:?ALK?needed someone with strong regulatory knowledge.?“Hardcore knowledge of?allergy products, European procedures, variation types,?PSUR Tracking…?We need someone who could challenge?and guide?us, especially if we?were?about to make a terrible decision. For example, when we?say,?‘We want?X’, we want someone who can tell us?–?‘No, you don’t want?X. You?want Y because it will offer you more?options in the future when you want to do Z" Ida says, with a laugh.

ALK chose Epista?because they?fulfill all?three points:?In addition to?being?a?certified Veeva partner, Epista also?has?a good?track record with?ALK.?This?knowledge of ALK’s?niche gave Ida confidence.?And finally, Ida says?“The industry recognizes that Epista has strong regulatory?knowledge, with just the?skill set?we needed”.

We needed?a?bridge?to take us from our current system?to the new one,?using best practices?suited to?ALK’s?specific?needs... The industry recognizes that Epista has strong regulatory?knowledge, with just the?skill set?we needed.?- Ida Bastian Brügger

Planning - key to a successful new system

Since the ultimate?RIM Vault?will take some time to implement, the project started?by mapping out?the?interim processes?for Vault Registrations. Epista helped ALK document a temporary process?to use during implementation, and then?a process for the final RIMS.?“Epista?also?helped us?document?the way to?a ‘future-perfect-world-process’, as well”, Ida adds.?Part of this effort required?ALK to get an overview of their documentation?– SOPs, work instructions, enclosures?- everything describing the current?RIMS.?For each item, they had to define?what should be replaced, updated?or?retired.?Also?in scope:?a?keystone of the project was to define the product structure. This?is?a?very important?building block,?used by many modules?in the?RIM Vault.

Ida describes the?heart?of the planning process:?“The biggest?task?was to go?through?every single field in our current RIMS. Using?Epista’s knowledge of business processes and the new RIM Vault,?we mapped?exactly which of the old fields were in,?and out of,?scope. For the?in-scope fields,?we figured out where they went in the new system. And maybe most importantly,?we figured out what we needed to do to the data to migrate?the field from?old system to?our?new?RIM Vault. Which should be transformed?to a new setup by either splitting the field or merging data, etc.?If Epista had not guided us?through this?early in the process, we could have wasted a lot of time?and effort?on cleaning up fields that would ultimately not be?used in the new system.”

Read the rest on our website to learn how ALK and Epista dealt with the planning process, coronavirus, and reached a successful overall outcome.