As a Fortune 500 company and a leader in the life sciences industry, Abbott has been striving to help people lead healthier lives for over 130 years. Spread out over 160 countries, employing 103,000 people, Abbott creates breakthrough products in diagnostics, medical devices, nutrition, and branded generic pharmaceuticals.
As a large, highly-awarded company with global reach and multiple divisions, including pharmaceutical, Abbott maximizes its use of digital solutions in order to execute business processes and to align across multiple functions globally. However, technology moves fast and is constantly changing. It isn’t possible for any company to constantly implement new IT solutions due to cost, impact to resources and/or difficulty with perpetual training on the use of these solutions. As such, it is beneficial to organizations large and small to have a solution that can grow and change as the organization evolves.
The Established Pharmaceutical division (EPD) of Abbott is responsible for manufacturing branded generic pharmaceutical products for the emerging markets. With a portfolio of over 1,500 brands sold globally, there was a large amount of product-related data to collect, manage and report.
EPD had multiple redundant IT systems in use across the division, which lead to inefficient business processes. In addition, many of the IT systems were older technology and several technical components were no longer supported leading to higher IT maintenance costs. With this in mind, they set out to achieve several goals:
Reduce the number of applications globally:
To reduce maintenance costs, an application rationalization focus was initiated. This would allow EPD to find just one system that could handle document management, submission management and publishing together across the entire division globally.
Accommodate emerging market processes:
Many of the division’s existing systems were built for developed markets (EU focused) and difficult to manage on a global scale. Multiple system improvements were required in order to support the management of emerging market products.
Build one repository for all controlled documents:
When employing the use of multiple systems to manage global and local controlled documents, it can be a challenge to locate documents and to facilitate the document change control process consistently across the division. Having a common repository and the same business process enables the use of
multiple robust change management tools including improved impact assessment of changes by applying relationships between documents in the repository.
Improve the process to manage Registered Position:
Tracking and communicating the registered position of what submission content has beenapproved at the health authority is critical for compliance. Having a business process that automates the tracking, organization and communication of the current/ approved information about the product ensures timely alignment across business functions - QA, Operations and Regulatory
Adapt to new ISO Standards - Identification of Medicinal Products (IDMP):
Some of the division’s legacy software systems had fallen out of step with the future IDMP standards and needed to be replaced by a system that would stay in alignment with the European Medicines Agency (EMA) and other health authority regulations.
A Phase Zero assessment helped the division understand exactly what they wanted from their new systems. The challenge at that point was finding one system that would accomplish all these requirements without needing multiple highly customized applications and third-party interfaces to connect each application.
During the selection process, several companies competed for a partnership with Abbott, with EPD choosing to partner with Amplexor. John Bates, RA Director for the Established Pharmaceuticals division, explains why:
The main driver: all the things we wanted [Amplexor] had within their unified solution. Most of our business requirements were met with the out of the box software. This enabled our division to standardize document management, submission management and dossier publishing processes globally across all
business functions. We expect our new system will help facilitate EPD to maximize our agility, speed and competitiveness to drive growth of our products.
John Bates, RA Director for the Established Pharmaceuticals division
Using a phased approach, Abbott and Amplexor completed the
deployment of this solution in two phases. Starting with document management for quality and regulatory submission ready documents during the first phase and ending with product registration management and publishing for our commercial affiliates during the second phase.
The EPD program team has accomplished the following milestones:
• Number of controlled documents under document control:
Approximately 2.5 million Quality, Manufacturing, Regulatory,
Pharmacovigilance, Clinical, Non-Clinical, IT, and Research & Development documents
• Number of product Applications under registration management: Approximately 12,000 Global and local products in APAC, CIS, EU, India, LATAM, and MEAP regions
• Number of Submission Records (historical and planned): Approximately 250,000 activities
• Publishing of all sequences related to 45 applications in eCTD format
• 11,000 total users trained and using the system
• Deployed to all global business functions
• Deployed to 29 manufacturing sites
• Deployed to affiliates in 110 countries
Moving forward, Abbott is continuing to partner with Amplexor to implement new requirements as they are deployed (e.g., IDMP) and new functionality on the Amplexor roadmap. In addition, Abbott continues to work with Amplexor to help drive changes due to new regulatory requirements through “voice of customer” discussions.