we recruit immediately : experimented Junior Scientist

Thursday 12 August 2010

Friday 09 July 2010

Opening Pandora's box - a discussion on opening your Regulated systems to the outside world?

Friday 09 July 2010

Business Cases

Document management: installation of validated platform Monday 02 March 2009

How, using an R&D GED, a GED for the business was defined and put in place

Context:

Document management within the company (GED / EDMS) is managed on a decentralised and separate basis, and must be consolidated to cover all the post functions and reduce the unit costs of the applications.

 

Objective:

1. To allow access to the GED for all management needs for controlled documentation.

2. To reduce the costs of installing, maintaining and validating each GED application.

3. To create good practices that help simplify document management processes.

4. To allow management of application versions and minimise the workload connected with change management.

5. To maximise the capacity of software components for re-use, and to minimise specific developments through applications.

 

Organisation of task:

• In the context of the R&D system migration, to introduce a sub-project for defining the platform, under the supervision of Quality Assurance.

• Definition of software architecture, identification of software and functional components, and formalisation of validation plan

Resources applied:

• One information system architect

• One validation consultant

 

Results:

Since the platform was introduced, six applications have been installed in the following functional domains:

• R&D (submission documents, Trial Master file (clinical), PSUR, non-submission documents, integration with publication tool)

• Packaging and artwork management

• Validation documentation

• SOP

• Contract management

Introduction of the ITIL process for managing incidents, problems, change and system administration