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Data integrity PIC S

good practices for data management and integrity in regulatory GMP/GDP environments

good practices for data management and integrity in regulatory GMP/GDP environments

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potential security weaknesses) and ensure operating systems are

maintained with current security measures.

Potential risk of not meeting expectations/items to be checked

Check that access to hardware and software is appropriately

secured, and restricted to authorised personnel.

Verify that suitable authentication methods are implemented. These

methods should include user IDs and passwords but other methods

are possible and may be required. However, it is essential that users

are positively identifiable.

For remote authentication to systems containing critical data

available via the internet; verify that additional authentication

techniques are employed such as the use of pass code tokens or

biometrics.

Verify that access to key operational parameters for systems is

appropriately controlled and that, where appropriate, systems

enforce the correct order of events and parameters in critical

sequences of GMP/GDP steps.

3. Expectation

Network protection

Network system security should include appropriate methods to detect and

prevent potential threats to data.

The level of network protection implemented should be based on an

assessment of data risk.

Firewalls should be used to prevent unauthorised access, and their rules

should be subject to periodic reviews against specifications in order to

ensure that they are set as restrictive as necessary, allowing only permitted

traffic. The reviews should be documented.

Firewalls should be supplemented with appropriate virus-protection or

intrusion prevention/detection systems to protect data and computerised

systems from attempted attacks and malware.

Potential risk of not meeting expectations/items to be checked

Inadequate network security presents risks associated with

vulnerability of systems from unauthorised access, misuse or

modification.

Check that appropriate measures to control network access are in

place. Processes should be in place for the authorisation,

monitoring and removal of access.

Systems should be designed to prevent threats and detect

attempted intrusions to the network and these measures should be

installed, monitored and maintained.

Firewall rules are typically subject to changes over time, e.g.

temporary opening of ports due to maintenance on servers etc. If

never reviewed, firewall rules may become obsolete permitting

unwanted traffic or intrusions.

PI 041-1 43 of 63 1 July 2021

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