including printouts and PDF reports.
• Ensure your quality management system defines
the frequency, roles and responsibilities.
• Your validation master plan must outline the
approach to reviewing metadata, including audit
• Schedule periodic re-evaluations.
Audit your audit trails
• An audit trail must include any changes that have
been made to a database or file.
• To be useful, an audit trail must answer: Who?
What? When? Why?
• Define the data relevant to GxP and ensure it’s
included in an audit trail.
• Assign roles and schedules for testing the audit
• The depth of an audit trail review should be based
on the complexity of the system.
• Understand what audit trails comprise: discrete
event logs, history files, database queries, reports
or other mechanisms that display events related
to the system, electronic records or raw data contained within the record.
Plan for business continuity
• Have a disaster recovery plan.
• Your plan must state how quickly functions can be
restored, as well as the impact of any data lost.
• Implement systems that backup data during power
outages or network downtime.
• Employ solutions such as UPS (Uninterrupted
Power Source), battery-powered, standalone
devices that can switch to an alternate power
source when required.
• Verify system inputs.
• Calibrate measurement devices regularly, accord-
ing to the needs of the sensors and operating/
• Validate networks. I.E. Test that data are coming
from the right location.
• Select systems with alarming functionality for
communication failure, device problems, or data
Select appropriate providers
• Ask for proof that systems are fit-for-purpose.
• Learn about your providers’ quality culture.
• Ensure providers are fluent in the regulations;
especially Part 11 & Annex 11.
• Ensure system software updates comply with
regulations, especially when implementing new
• Collaborate with providers to stay informed
about changes and update your systems.
• Select systems that are easy to update upon
expansion or the addition of new system inputs.
Qualify IT & validate systems
• Validated systems require an IT environment
that has been qualified.
• Backup electronic data on a pre-set schedule to
a secure location, including metadata.
• Verify the retrieval of all of data during internal
• Electronic archives should be validated, secured
and maintained in a state of control throughout
the data life cycle.
Getting data you (and your auditors) can trust
For many systems in GxP-regulated applications,
there are common scenarios with expensive risks.
An undetected compressor failure on a weekend
could destroy the entire contents of a chamber
storing samples from research in a crucial stage of
In GxP applications, data represents significant investments in development, clinical trials,
donated tissue, and the hopes of patients for a
new therapy or drug. System devices, software,
infrastructure, processes and operating procedures must all ensure that data are complete,
consistent, accurate, and exemplifying the characteristics of ALCOA+.
Piritta Maunu is a Life Science Industry Expert for
Vaisala. She has worked as a Quality Manager in R&D
and GMP production. Piritta holds a M.Sc. in Cell
Biology and is an instructor of General Biology.