TABLE OF CONTENTS Networked CDS systems will require IT support and maintenance that will need to be formalised in a service level agreement (SLA). The IT group will also need to work in a compliant manner ( e.g. written procedures with evidence that they have been followed) or the effort to validate the application will be wasted. Two of the key elements that will be included in an SLA are discussed here namely backup and recovery and time stamps.
The impact of electronic record and electronic signature regulations17 also means that data must be backed up effectively to avoid data loss as 21 CFR 11 has specific requirements that involve backup and recovery of your chromatographic data:
11.10(c)
Protection of records to enable their accurate and ready retrieval throughout the records retention period.
Clause 1327:
Data should be secured by physical or electronic means against wilful or accidental damage, in accordance with item 4.9 of the Guide. Stored data should be checked for accessibility, durability and accuracy. If changes are proposed to the computer equipment or its programs, the above mentioned, checks should be performed at a frequency appropriate for the storage medium being used.
Clause 14:
Data should be protected by backing-up at regular intervals. Back-up data should be stored as long as necessary at a separate and secure location.
Section 19.131:
The security of the system and security of the data is...
