Headlines - June 2011
Important Annex 11 Changes for Computerised
Systems come into effect
Earlier in this year, new revisions of the
European Union (EU) GMP Annex 11 on Computerised Systems and Chapter
4 on Documentation were published. As of 30th June 2011, the
deadline for these coming into operation has been reached.
The impact of Annex 11 is extensive and is widely
considered to be the EU equivalent of the US FDA 21 CFR Part 11.
For a computerised system, Annex 11 requires "the extent of validation
and data integrity controls should be based on a justified and
documented risk assessment of the computerised system".
The wide-reaching scope of Annex 11 impacts on
• IT Infrastructure
•
Roles & Responsibilities
•
Suppliers & Service Providers
•
Validation
•
Data Integrity
•
Electronic Signatures
•
Incident Management
•
Business Continuity
•
Maintaining the validated, compliant status
It is very important companies and suppliers
address these revised rules and regulations immediately.
Compliance Control Ltd. have far-reaching
experience helping companies conduct validation and qualification
activities covering computer systems and IT Infrastructure for a
number of years, primarily based on US FDA regulations.
With this extensive know-how , Compliance Control
Ltd. are well placed to help your business understand what the
revised regulations mean, and what the impact on your operations
will be, now the regulatory need has been made clear in the EU.
Please
contact us to arrange a one day assessment/audit, which will
result in a detailed report outlining what these changes mean for
you and your business.
As we have designed ComplianceControl Centre to
conform to 21 CFR Part 11, it is therefore already fully compliant
with the new EU regulations.
Please
contact us to find out how ComplianceControl Centre can help you
comply with the new regulations.