Acando had 8 consultants working with Daiichi Pharmaceuticals for 2 years across Japan, USA and the UK. Daiichi Pharmaceuticals approached Acando for help with the analysis, design, implementation and deployment of a global Documentum system to provide a repository for the sharing of drug-related documentation that met the current and future demands of the Regulatory Authorities.
Project and Client Background
Daiichi Pharmaceutical Co Ltd is one of Japan’s leading pharmaceutical companies with subsidiaries across the world. They specialise in anti-infective, internal medicine and anti-cancer drugs with a strong pipeline of new drugs and expanded indications in development. In support of this Daiichi produce reports known as submissions, which are sent to Regulatory Authorities globally. These authorities issue licences to allow the manufacture and distribution of new drugs.
To support the production of these submissions Daiichi embarked upon a project entitled EverGreen to manage the creation, review & approval of all regulatory documents globally.
The goal of the Project was to give 3,000 people across the world at any Daiichi site access to EverGreen, which would replace all current systems used for regulatory documents. The users would be able to access, dispatch and track all regulatory documents submitted in support and defence of a product during its life.
Acando deployed technical teams within the main EverGreen project since the project started, although Acando has worked with Daiichi on several smaller projects previously.
Project Business Benefits
The main business benefits to be accomplished by the system were to:
• Enable the global sharing of drug documentation within a secure environment
• Reduce the time required to complete regulatory documentation and submission
• Meet the current and future expectations of the Regulatory Authorities
• Decrease the response time to Regulatory Authorities’ queries
• Enhance the quality of regulatory submissions
• Provide a single point EDMS solution for all those involved in the documentation and submissions process
• Replace multiple systems with one global standardised system
Project Requirements
As with any project of this nature, the most important aspect is the business process definition to achieve the end objective. Once this has been established the technology to enable it can be selected and implemented. In Daiichi this has been in 4 distinct phases:
1. The conceptual design to meet full electronic submission
2. Selection of Documentum as the core document and content management system
3. Fine-tuning of the business processes, building upon Documentum’s capabilities
4. Implementation of the final publishing solution
Acando provided the business and technical expertise to satisfy these requirements.
Solution
In order to provide the best solution for Daiichi in the most cost-effective and timely manner, the implementation was broken down into phases, with each phase being validated to form a sound base on which to build the next phase.
The first phase was to implement replicated Documentum Docbases at each of the three Daiichi locations. This meant that each site had access to the same data, and in a responsive manner since the content was stored locally. It also added a level of redundancy to the system so that, in the event of a server failure at one location, the information could be retrieved from another site. A folder structure corresponding to the CTD was built for each drug and legacy documents imported. All of the work at this stage (and following stages) had been carried out strictly following the pharmaceutical industry GAMP guidelines.
Phase 2 allowed Daiichi to use Documentum in the creation, checking, reviewing and approval stages of document preparation. This involved the use of workflows, document attributes and renditions to satisfy the US regulatory 21CFR Part 11 requirements.
The final stage of the EverGreen project was the fully electronic submission to Common Technical Document (CTD) and Electronic Common Technical Document (eCTD) standards. A publishing system was also integrated with the main Documentum system.
The Team
The Acando team:
Managed the project globally-
Assisted in the business process concepts-
Advised on the detail system design-
Carried out all configuration and customisation-
Produced all of the project documentation-
Assisted with on-site testing-
Provided all Train the Trainer classes and end user training-
Provided system support to all three sites
Summary
Acando provided a number of Business, Technical and Project Consultants to assist in the successful design and deployment of Daiichi’s new processes aligned to the Documentum EDMS technology. The added dimension was that of providing the solution globally to the three major locations simultaneously.
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