White Paper: How to Achieve Pharma Compliance with Lab Balances
Overview
It is required by the United States Food and Drug Administration that data be accurate, legible, contemporaneous, original and attributable (ALCOA). Sartorius’ Cubis® II is designed with these data integrity principles in mind.
Our pharma package contains the technical controls needed to support compliance with common regulations, and full compliance can easily be achieved with additional procedural controls and systems for long-term data storage.
Download this informative white paper and learn about how Sartorius makes compliance easy with features like audit trails and electronic signatures.
Commonly Asked Questions:
- What is integrity in pharma?
- Any system that stores, retrieves or processes important research data must pass the integrity and standards check in pharma. This is to ensure the information stays consistent and accurate throughout the life cycle. Data must also be protected from manipulation or falsification.
- What is FDA 21 CFR Part 11 Compliance?
- This regulation deals with access control, audit trails and electronic signatures and states that electronic records and electronic signatures are to be treated the same as paper records and handwritten signatures. Regulated companies must comply with this rule.