METIS gives you benefits of introduction of data historian software in todays GMP manufacturing inspection readyness
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Affordable
Easy to implement at a low price with little tech requirements
Data Safety & Security
Data integrity requirements
are essential for GMP driven oranizations
GxP ready
Fullfills rquirements from FDA Part 11 & Euralex Annex 11
Third-party Collaboration
METIS understands the significance of seamless
integration with various third-party platforms and tools.
Your Benefits
METIS is your strong partner for data in GxP
Data integrity and security
Fullfills requirements of CFR Part 11 and Eurdalex Annex 11
Affordable and EXCEL based
METIS
is inexpensive to buy, implement, maintain, and requires little IT
infrastructure to run
Backup,
Archival, and Continuity
METIS
integrates robust backup and archival solutions, ensuring that data is
safeguarded against unforeseen events and remains accessible over the years.
METIS Features
METIS offers a what you need in your GxP environment
GMP ready
Qualified for GxP - you only have to run your own IQ
WORM technology
write once, read many -
Data stored on a WORM-compliant device is considered immutable; authorized users can read data as often as needed, but they cannot change it.
AUDIT trail
Audit trail – who approved, who changed and who worked on the data/system
In today´s GMP regulated Life Science it is our duty to ensure that our organizations harness the power of data effectively. A data historian software is a powerful tool that allows organizations to capture, store and analyze vast amounts of data in real-time. It not only provides a historical record of data but also enables companies to gain valuable insights into their operations, detect patterns, and make more informed decisions.
Here are a few reasons why investing in a data historian software should be a top priority for your company. We want to start with regulatory compliance and data integrity as these are the main risks in our industry to receive warning letters by the authorities.
Regulatory Compliance
In today's data-driven world, compliance with data protection regulations is crucial.
A data historian software ensures data integrity, security, and privacy, which
are essential for complying with GxP industry-specific regulations and
maintaining customer trust.
Data Integrity Safety & WORM
Two prominent sets of regulations addressing data integrity requirements are the FDA's Title 21 CFR Part 11 and the EU's GMP Eudralex Volume 4, Chapter 4 and Annex 11.
These regulations provide guidelines for the creation, handling, and
storage of data in computerized systems.
White Paper - Data Historian
In this paper, we provide valuable insights into data management best practices for life science systems.
Additionally, we will outline the expectations laid out by regulatory bodies in this field.
