Meeting the Data Integrity challenge
Increased regulatory focus on data integrity is affecting the entire pharmaceutical industry. Data-generating systems and processes are, today, coming under intense scrutiny.
Electronic and paper-based data must meet stringent requirements over the entire data life cycle. For example, as defined by ALCOA – requiring data to be Attributable, Legible, Contemporaneous, Original and Accurate.
Companies need to ensure correct controls are in place and continually managed in order to reduce the risk of non-compliance. It is a complex issue affecting many functions within an organization, including operations, technology, lab, production, QA and IT.
PlantVision has taken a leading position within the area of data integrity. We can help to drive comprehensive data integrity initiatives, or provide specific services to support whatever stage your organization has reached.
1) KNOWLEDGE – Basic and advanced training for those affected by data integrity.
2) INSIGHT – Workshops to identify challenges/opportunities and carry out GAP analyses.
3) INVENTORY – Inventories of all instruments and systems that impact data integrity.
4) ASSESSMENT – Mapping out of risks and identifying where/how business value will be realized.
5) DECISION – Planning project implementation and developing an implementation strategy.
6) ACTIONS – Carrying out planned, prioritized actions, such as instrument/system qualification and validation, implementing new technical solutions, and developing SOPs, etc.
7) LIFE CYCLE MANAGEMENT – Implementing routines and support processes to ensure continued compliance.
Efficient implementation + improvement opportunities
Working with PlantVision brings with it additional benefits. We combine a holistic approach with in-depth expertise for integrating information systems, upgrading/implementing new technical solutions, and improving processes and working methods.
It means your data integrity project can simultaneously achieve operational improvements and generate additional sustainable business value.
- Ensure GMP/GLP/GxP compliance relating to data integrity
- Enhance quality systems and streamline processes
- Improve production performance
- Increase operational flexibility
- Reduce costs, shorten lead times and minimize waste