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To control the flows of purchase, production, control, sales, finance... is often the purpose of an ERP solution .
Today, the control of the processes is maintained by identification of the risks and their mitigations. The risks are those dictated to us by the various regulations, which are financial or pharmaceutical.
The ERP Center of Excellence may aid clients and consultants with in-depth knowledge and experience of engineering the requirements and validation on computerised ERP systems.
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We can offer you:
- Modeling and analysis of your process flows,
- Rationalisation of your process flows by combining regulatory, financial and other constraints,
- Drafting your requirements, integrating your business and regulatory constraints (BPF, BPD, cGMP, ICH and 21 CFR Part 11, SOX, LSF),
- Follow-up on the invitation to tender and suggested solutions,
- To work closely with the chosen integrator to develop functional specifications (basic parameter settings, process definitions),
- To assemble your validation file (Analysis of risks by process, validation plan, design qualification, IQ, OQ, PQ, traceability matrix and reports),
- To analyse your data recovery or migration problems and propose a strategy,
- Benefit from our experience with Change Management for your system,
- Preperation and support for training
- Assistance developing and formalising system and IT procedures.
- Audit the use of your tool against regulatory requirements ( BPF, cGMP, ICH, 21 CFR Part 11),
- Document audit (review of the validation file and associated operational procedures),
- To analyse non-conformances and propose corrective actions,
- the update of your validation file or complete validation of your system if required.
We can propose automated solutions which will make it possible to optimise the management of your system and its implementation
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