Project management
Our experts evaluate your software processes as a function of standard references. We position your processes versus the state of the art and analyse the variances observed. We also supply you with pragmatic and concrete advice allowing you to make major improvements in your project management.
Our offer
Project management:
- Contextualising and positioning the project;
- Project planning;
- Project supervision.
Project documentation:
- Specifications, user requirement specifications (URS);
- Functional Specifications (FS) and Detailed Specifications (DS);
- Detailed Specifications (DS);
- System architecture;
- Design review;
- Categorisation/Evaluation of criticality;
- ERES evaluation (21CFR11, EuGMP, appendix 11, PI011);
- Drafting the migration and deployment plan;
- Drafting the withdrawal plan;
- Drafting documents relating to archiving.
System configuration:
- Configuration of the system in conformity with users’ needs;
- Encryption and verification;
- Tests of technical data;
- Generating test and validation data;
- Data recovery/Migration.
Plans of tests, runs / verification of the tests performed:
- Integration and acceptance tests.