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The Laboratory Centre of Excellence is a technical and regulatory resource for ADN clients and consultants
Computerised systems are used effectively everywhere within the laboratories of Quality control or Research and Development,
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These systems play a key part in critical pharmaceutical processes:
- pharmacokinetic studies etc.
Computerised laboratory systems constitute a critical core and are subject to regulatory scrutiny. Proof that these systems are under control throughout their lifecycle must be evident.
The ADN Laboratory Centre of Excellence has experience in applications as well as laboratory regulations and practice. We can help you with:
Acquisition of new systems and update of the existing systems
- Process modelling and requirements capture
- Requirements Analysis
- Drafting requirements (User Requirements)
Using our expertise in:
- Project Management
- Requirements Engineering and Validation :
-Risk Analysis
-Design review
-IQ,OQ,PQ
-Traceability Matrix
-Reports (IQ,OQ,PQ and the final validation report)
- IT Infrastructure
- Laboratory data archiving
Installation of processes so that the validated state may be maintained:
- Change and Configuration Management Processes
We can also help you to evaluate the impact of your systems on your company processes and to optimise:
- Control data flow from these systems
- Planning corrective actions, (i.e. : 21 CFR PART 11 remediation)
- Qualification and validation of the solution designed around your requirements and the regulations in force.
We utilise the following methodologies, requirements and regulations:
- Predicate rules (ex. GLP )
- 21CFR PART 11
- ICHs
- BPL, BPF
- GAMP 4 and GAMP 5
