Electronic Document Management System (EDMS) implementation
The challenge of implementing a document management system (Documentum, OpenText, AlFresco, SharePoint, etc.) implies a significant effort at the level of the project, given that it needs to be dimensioned appropriately and the need to validate is obvious due to the GxP criticality of the system.
From the GxP point of view there are various aspects that should be taken into account:
- How can the principles of security, reliability and integrity of the information be ensured?
- The design of the review and approval flows need to be appropriate for the internal organization of the company and satisfactory when faced with an audit or inspection.
- Distribution of the documentation to collaborators who are users of the system, but also to collaborators who receive paper copy.
- How to migrate system documentation that is at the very focus of substitution by the new documentation management system?
- How to harmonise the system so that all the companies of a corporate group make use of the same model?
Validation, as well as being a regulatory requirement, becomes a key component and point of reference that ensures that the above aspects will be appropriately addressed during the implementation process.
Our approach, the fruit of many previous EDMS projects, is based on the following strategy:
Definition of a Master Validation Plan which establishes the general platform validation methodology and the particularities of the implementation. Once this is done, the qualification protocols for the elements that are common to the companies / divisions / departments of the same group:
- Qualification of the platform elements.
- Qualification of the common functionalities: management of documents, distribution processes, backup, etc.
For each implementation (company / division / department) a specific Roll-out plan will be created where, as well as the particular functionalities that can be present, special emphasis will be given to:
- Verification of the migration of data from the legacy document manager.
- Confirmation of the correct application of the defined flows.
- Correct definition of the document types.
In this way, i.e. using a methodological approach to the implementation project activities, validation will be the tool to review and check the correct design and system implementation at the corporate and individual level.
This strategy is the result of having worked on many different projects.