9Oct
OSIsoft PI Validation
Our focus in intilaris quality solutions is in OSIsoft PI validation.
Intilaris is a Swiss GxP Quality company delivering:
- GxP Validation and Data integrity
- Quality Management in GxP Projects
- GxP Compliance Management
- Risk Based Testing
- Agile and Lean GxP Validation Projects
intilaris Validation, Re-validation and Data Integrity Service ensure that PI collection of data is compliant, complete, consistent and accurate throughout the data lifecycle.
Pharma & Life Sciences and Food & Beverage customers benefit from synergy between OSIsoft expertise in delivering PI solutions and intilaris GxP know-how in establishing such solutions in regulated environments.
OSIsoft is a proven leader in enabling operational excellence of pharma, biotech and food & beverages industry customers to transform and digitalize industrial applications in regulated environments.
Often our customers in regulated industries such as Pharma or Food and Beverages are faced with a classical business challenge – How to implement Enterprise wide PI system time and cost effectively? The solution to this challenge is to:
- Standardize deployment & validation approach
- Maximize tests and documentation reuse
- Employ electronic tool to manage the validation
Our OSIsoft PI Validation and Re-validation Service
Validation of the GxP relevant computerized systems in life sciences industry is one of the basic requirements. The digitalization and increasing automation in the industry has contributed to growing complexity in the IT space and integration between various systems. That increase in the complexity has the corresponding increase in the cost of compliance.
To reduce the cost of your compliance our consultants can support your validation, revalidation and life-cycle management efforts in either:
- Risk-based V-model computerized system validation (CSV)
- Agile Computerized Systems Validation
With either of the two approaches, we will support your organization through cost-effective qualification and validation to achieve:
- GxP validated IT systems and processes
- Compliance to current standards: 21 CFR part 11, Annex 11, and GAMP 5
- Validation and Revalidation cost reduction
For an in-depth conversation on this topic, please reach out to us.
intilaris LifeSciences – LinkedIn
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