Bringing systems in line with data-driven ambitions

Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorisation submissions.

Potential associated benefits to companies themselves include: improved decision-making; optimised health authority interactions; increased regulatory intelligence; and streamlined data exchange between business functions.

But this requires that regulatory information management system (RIMS) upgrades are approached holistically. Common issues, and appropriate recommendations, can be broken down into system challenges, process challenges and matters of data governance, as discussed below.

Although the transition from document-centric information delivery to a data-first environment is not entirely a technology issue, technology will form the foundation through which everyday order, consistent format and structure, data quality, and status visibility are maintained and improved.

Many companies have realised now that there will never be a definitive point in time when all the new requirements are set in stone, and that a more agile methodology is more appropriate to enable flexibility.

Yet this can bring its own challenges as teams adapt.

1. The need to develop an agile mindset around the RIMS upgrade.
2. Gaps in existing data captured within the central RIM system.
3. The data collection effort required for upcoming regulations.
4. The need to transform existing data to the new standard fields as the data model is updated.
5. Establishing the right culture and approach around data quality management.
6. Existing reports needing to be reviewed in the light of the system upgrade.
7. The need for an assessment of existing systems integrations.
8. Decisions that now to be made around legacy data/product information management.

However powerful the new system, the scope for transformation will be limited unless associated business processes are optimised to take advantage of a continuous flow of good-quality, standardised product and registration data.

This starts with ensuring that the new or updated system works better for everyone.

With increased dependence on and requirements for regulated data, RIMS is finally gaining traction as the facilitator and enabler of the regulatory function. But, in reality, business processes will need to be remodelled, as it is better not to pursue customisation – in the interests of maintaining simplicity through standardisation.

Setting up a process framework using a (Business) Process Architecture methodology allows a clear overview of all of the process steps, increasing everyone’s understanding of relationships and dependencies between specific processes, while also making it possible to drill down into more detailed process steps as needed.

Inevitably the addition of new data-based capabilities, e.g. in preparation for EU IDMP compliance, will require the adaptation of business and system processes. Numerous updates and changes to documentation can be a laborious and inefficient process if done manually.

Considerable duplication of documentation can exist across functional subdivisions, too. Having one harmonised master can substantially reduce the update effort and associated user training.

To date, life sciences companies have struggled with setting up proper data governance measures. Unless these are addressed, they risk compromising the potential of their RIMS and process optimisation. Challenges include:

1. Data roles (including data owner, data stewards) to date not being clearly defined. By now, a governing body and associated process should exist to assign roles and responsibilities.
2. Data definitions, business rules, and data quality requirements and metrics need to be established. A unit dedicated to this will speed all of this up.
3. The need for central coordination of controlled vocabularies, organisation records, substance information and specific product identifiers.

1. Multiple business stakeholders being involved and have a detailed understanding of the intended data model, as well as the target system and business processes.
2. Establishing a data governance body with defined roles and remits.
3. Business reporting, using data in the RIM system (both for regulatory compliance and process checks/efficiency), being provided for in its own right – by region, timeline, etc.
4. Remediation of existing data within the RIMS to ensure it is reliable, complies with upcoming regulations, and can be trusted as a definitive source of truth.
5. Clear and proactive communication about regulatory expectations to end users. This also requires appropriate training.

Although the demands of data-based RIM transformation can seem overwhelming, the rewards are potentially unlimited – provided companies act now.

Cultivating an organisational culture that recognises the value of good data and fosters the right environment to drive this is crucial. Then it becomes a matter of simply scoping and planning technology initiatives with an understanding that projects will need to be incremental and additive.

Keeping in mind that the end goals go beyond compliance for its own sake will help keep initiatives all-inclusive and continuously evolving, while ensuring maximum returns.

Process-wise, as long as improvements are supported by effective change management, there is an opportunity for extensive modernisation of the product life cycle – ultimately leading to more affordable and accessible offerings for patients.

Adnan Jamil is a Manager at Iperion, a Deloitte business. Go to deloitte.com