Acando had 5 consultants working with Solvay Pharmaceuticals for 18 months globally. Solvay Pharmaceuticals turned to Acando for help with the deployment of Documentum & FCG’s FirstDocs suite of products for the production, control and publishing of quality documentation.
Project and Client Background
Solvay Pharmaceuticals is a global research-based pharmaceutical group of companies dedicated to improving quality of life of patients and supporting their healthcare professionals in the therapeutic areas of cardiology, gastroenterology, mental health and hormone replacement therapy. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.
Solvay Pharmaceuticals, in Europe and the USA, has employed several Documentum-based document management systems in a global capacity since 1996. These systems supported the authoring, workflow, and lifecycle management for regulatory submission documents as well as other regulated business documents, such as Standard Operating Procedures. Globally, there were approximately 250,000 documents stored within these systems and each was a separate installation.
Solvay Pharmaceuticals identified that a global upgrade of the existing Documentum environment was necessary in order to:
• Ensure compliance with 21 CFR Part 11. The earlier versions of Documentum software were not fully compliant with the electronic records and electronic signature requirements in 21CFR11, which was the major reason Solvay Pharmaceuticals was still reliant on paper as the ‘official’ document.
• Improve the global business processes (R&D and Manufacturing) and their corresponding Workflows as well as optimizing the IT costs.
• Keep pace with technological evolutions. The versions of Documentum products currently in use were not certified by the manufacturer with Windows 2000.
• Maintaining Supplier Support for the versions of the Oracle database, Documentum backbone, and Documentum add-on products currently in use had grown increasingly difficult and limited. Acando was responsible for delivering focused end-user training to users globally across 6 Solvay sites and in local language where required. The training solution involved the utilisation of an Acando Training Manager, 4 Training Consultants and 1 Technical Training Consultant during an 18-month period.
Project Requirements & Solution
Solvay Pharmaceuticals implemented FirstDoc GMP globally installing a localised system for Spain, France and Germany. The global project team took the decision to implement a global training strategy which was to be managed centrally; this was then to be localised for each site. Additionally, a modular approach was required in order that training was focused on Solvay Business Roles, modules for Viewers, Reviewers and Approvers, Authors and Coordinators were developed.
The first step of the development phase involved the writing of a General User Manual which contained the core functionality relating to the SOLID system. This General User Manual was made available to all users from the company intranet and is used to support the Business Administrator role. Once this had been written and signed-off by Solvay the content was used to compose the Quick Reference Guides, resulting in a timely and efficient development of ILT materials.
Training Strategy
Acando in conjunction with Solvay Pharmaceuticals developed and implemented a Global Training Strategy in order to have a centrally controlled and managed solution which was then localised for each site.
Localisation
Solvay Pharmaceuticals implemented localised versions of the FirstDoc GMP system for Spain, France and Germany, therefore having developed ILT materials in English for the Global solution Acando managed the localisation and translation of materials for each site. In addition for those sites requiring training in the local language Acando provided Consultants who are fluent in the language.
Where a localised system was not implemented Acando provided consultants with local language skills to assist with explanations, understanding and cultural issues.
Pilot
A pilot course for each module was held in order that the content and duration of each module was assessed and confirmed, as a result the duration of modules were increased to ensure users had sufficient time to cover all topics, complete the required assessment activities and in order that the business could determine that learning had taken place before access to the production system could be granted. In addition this enabled the project to test that the Training Docbase requirements had been met successfully.
Training Manager
Acando provided a Training Manager whose responsibility it was to work alongside Solvay’s to ensure consistent high quality deliverables for all phases of the training project. This involved the development of key project documentation including the Training Strategy and Project Plan.
The Training Manager worked closely with key project personnel on a global and local level to establish and deliver the local training solution and was responsible for the management of high quality translation services for the required project documentation. The Training Manager was also responsible for monitoring and reporting of project costs and for supplying the business with regular cost updates.
Technical Training
Acando worked closely with Solvay Pharmaceuticals and FCG to coordinate and deliver high-level technical training to Business Administrators. This involved training in the technical aspects of FirstDoc as well as Solvay’s specific functionality and customisations.
Train the Trainer
Acando developed a bespoke Train the Trainer programme for each site in order to meet the requirement for internal Solvay personnel to deliver ongoing training at the local site.
Summary
Acando has worked closely with Solvay Pharmaceuticals to develop and deliver a quality bespoke training solution to 6 locations globally in local language where required and to meet the specific needs of the local business.
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