Life Sciences companies are under pressure to reduce the costs of regulatory operations and speed up health agency approval to accelerate time to market. However, this is no easy task!
Each organization is in a unique place on the Regulatory Information Management (RIM) continuum – some need to put a foundational content management system in place, others are trying to unify processes with affiliates or shrink their dependency on spreadsheets and yet, others are trying to rationalize myriad and duplicative systems to streamline processes and drive down costs.
Fortunately, I have a bevy of regulatory experts ready to share their knowledge and experience to help you meet your RIM goals regardless of where your company falls on the continuum.
Regulatory Information Management is Complex!
First, the regulatory landscape is complex and always changing so just keeping up with regulatory requirements across global markets is challenging.
Second, organizations are often in varying degrees of maturity when it comes to regulatory processes. Some organizations do not have a content management system in place to help manage all their controlled documentation including how documents are created, reviewed, approved, trained on, distributed for use, revised and retired.
On the other end of the spectrum, some companies manage multiple content management systems and are striving to rationalize them in a way that streamlines operations and reduces costs yet ensures information accessibility and compliance.
For most companies, regulatory processes span a myriad of disjointed systems and processes. Operational complexity reigns and accessibility and usability are problematic. Due to these challenges, regulatory organizations struggle to efficiently submit to regulatory agencies. They struggle to know which of their products are registered in specific markets. Sponsors often lack visibility into the exact contents of submissions within each country or region. And keeping track of agency interactions brings yet another collection of systems and applications into the mix.
Changes clearly need to happen to achieve the goal of accelerating time to market when it comes to RIM. Life Sciences organizations must improve efficiency and productivity, as well as, data quality, accuracy and compliance.
Where Do I Start?
If your company is one that doesn’t currently have a content management system in place, let’s look at two fundamental capabilities outlined by Gens and Associates in their Drug Information Association (DIA) presentation, “Measuring and Achieving World Class RIM”, that companies must do very efficiently when pursuing an effective (and world class) RIM strategy.
- R&D Document Management: Organizations must have a streamlined process for the creation, review and management of submission documentation. By leveraging industry-standard dictionaries, taxonomies and object models combined with a template-based authoring process and collaborative review process, the speed, accuracy and completeness of submission-ready documentation can be improved. Documentum Research and Development helps ensure the efficient creation of accurate and complete submission documentation.
- Health Authority Interactions (Q&A, correspondence): On-going communications with Health Authorities continue throughout the drug lifecycle. Organizations need easy access to regulatory submissions and the associated regulatory correspondence to enable a complete view of regulatory activity. Submission Store and View simplifies the search and retrieval of archived submissions and their associated correspondence, while improving security and compliance. The solution links regulatory correspondence and communications to submission files, enabling a full view of regulatory activity within a scalable, secure Documentum repository.
If your organization falls into the second camp where you are trying to rationalize multiple and often duplicative systems, let’s look at another key consideration – the need for a single source of truth for regulated content.
While most Life Sciences organizations operate in silos; content follows the lifecycle of the drug. Therefore, having a single authoritative source across all functional areas breaks down information silos and enables documents in one domain to be used by key stakeholders in another.
This approach minimizes discrepancies and uncontrolled copies, ensuring that information is accurate, timely and accessible. Organizations can respond faster to product changes, compliance concerns or health authority requests.
How Can I Ensure Success?
Regardless of where you are in terms of your Regulatory Information Management initiatives, there is certainly lots to figure out. RIM is not easy but it’s essential to driving more efficient regulatory processes and accelerating time to market.
- Where does your company fall on the RIM continuum?
- What challenges are your experiencing that we can help you with?
- Do you have some best practices to share based on your own success?
Read more on Life Sciences and how we are helping here.