When it comes to GxP and data integrity, there are a number of issues your lab organization needs to focus on, including:
- How do you ensure user identities are correctly used?
- How do you ensure that all data is reported? How are atypical results handled? Are batches pre-tested?
- How do you ensure that data is not lost or modified?
- Do you save the same data in different places? (Primary data in relation to raw data?) How is data stored?
- Is your data transfer process from lab instruments to LIMS properly validated?
- Do you have permission routines? Who has access to results data on lab instruments/storage media?
- Are your systems and software configured and validated for their intended purpose?
- Are your standard routines specific enough? Are all routines followed?
- How do you ensure researchers and QC personnel have the required training (in data integrity and/or the methods performed)?
- What does your infrastructure look like for lab instruments and equipment?
Smart Lab Solutions
We have extensive experience with smart lab solutions, quality assurance and change management. We can support you with effective integration of lab processes, personnel and systems to meet GMP/GLP/GxP demands relating to data integrity while simultaneously:
- Enhancing quality systems and streamlining processes
- Improving operational flexibility
Reducing costs and shortening lead times
We support you at every stage
1) KNOWLEDGE – Basic and advanced training for those affected by data integrity.
2) INSIGHT – Workshops to identify, prioritize and explore challenges/opportunities.
3) INVENTORY – Inventories and gap analysis relating to instruments and systems that impact data integrity.
4) ASSESSMENT – Mapping out of information flows, quality systems and lab processes.
5) DECISION – Development of risk-based portfolio of prioritized, flexible and future-proof laboratory solutions that meet regulatory demands, enable data lifecycle management and minimize lab complexity.
6) ACTIONS – Lead, coordinate and carry out quality-related projects, and support change programs. Perform validation and qualification services, including risk assessment and requirements management.
7) LIFE CYCLE MANAGEMENT – Support for planning and implementation of efficient administration solutions.