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Clinical Trial

Computer System Maintenance Plan

This document provides guidance and recommendations regarding the maintenance of newcomputerised systems within clinical trials. Computerised systems are defined as systemsthat collect data in electronic form and create, modify, maintain, archive, retrieve or transmitthat clinical data.

As source data are necessary for the reconstruction and evaluation of the trial to determine

the safety of IMPs this document is intended to provide guidance to ensure confidence in thereliability, uality, and integrity of electronic records..

Plan Outline

!or in"house systems, the validated state should be maintained from the beginning of thesystems life through to its end and decommissioning. The following steps are recommendedto document to describe and deploy a maintenance plan#

$. Maintenance Control %heet# A document control sheet indicates the current version ofthe plan along with the revision history documents.

&. Approval of Plan# A sheet indicating the signatories that show approval for the Planfrom within the 'CT( and maintenance group.

). (peration Management of the %ystem# A brief outline of the system and how it isused. It should record any hardware or operating system reuirements that differ usergroups and identify the ma*or user types for the Computer %ystem.

+. %ecurity Plan# A document providing the details of how the hardware or software isprotected against loss i.e.# physical security for hardware and the prevention orunauthorised physical access to the computer system or logical security for theprevention or unauthorised access to the software application-s. Procedures should in

place should be detailed, including#

a. ules and responsibilities for assigning access rights.

b. /se of electronic signatures is adeuately controlled e.g.# password andusername definitions0.

c. Access rights are reviewed periodically to ensure they are appropriate e.g.timed with monitoring visits or permissions given for a new user0.

d. All users receive appropriate training in the use of the system.

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e. 3irus protection measures.f. 4ocumentation of routine bac5"ups and the intervals of bac5"ups *ustified

where necessary.

6. is5 Assessment# A list of the possible ris5s to the computer system when in use andthe li5ely resolution should the ris5 arise.

7. Change Management# It is necessary to control changes to a system in order toensure that it continues to function correctly. Procedures should be recorded toidentify, authorise, validate and install changes to the system, including#

a. 8ardware

b. %oftware

c. 9nvironment i.e. (%0

d. 8ardware or software configurations

e. Changes in system use

!or systems developed for larger solutions to clinical trials over multiple trusts or companies,it is further recommended that a periodic review of the maintenance plan is underta5en toensure that the validated system continues to perform as e:pected.

The validation status of a system should be reviewed periodically when the system is used inmultiple environments and in multiple instances such as a database specification tool0. Thiswill help in capturing unnoticed changes e.g.# networ5 software, (% updates0. The periodicreview should ta5e place at least every 6 years if no other ma*or validation activity hasoccurred.

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