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Electronic Quality Systems

electronic-quality-1.pngDeveloping and implementing an electronic quality system is a very exciting project to be a part of. This is a great opportunity to take a holistic approach in evaluating what your requirements are for the system and how that system will fulfill those needs. The following are several tips and points that should be considered during the development of your system. The intent is to provide options and rationale to potential system owners / developers about aspects of an electronic quality system which may be easily overlooked.

Whenever the record is going to be reviewed, by the Quality unit for example, for either an initial risk assessment or final closure, the record should be ‘locked down’. Locking down a record is just that, ensuring that all fields and data entry points, excluding those needed to be entered by the Quality unit, are unable to be edited. This is to make certain the record doesn’t become a moving target, and that the information captured within the record will not be revised by individuals outside of the Quality unit during review and subsequent decision making process / execution.

It is the responsibility of the Quality unit to ensure that the records within the electronic quality system are factual, accurate, and conclusive, so there are times when these records will need to be rejected, or backed up to a previous state. In brief, it is highly improbable that every record submitted to the Quality unit for review / approval will be correct the first time, therefore it is key to build into the electronic quality system a back up process flow to allow the record to be revised and corrected appropriately.

What stems from the reject / back up process flow, is the opportunity to capture the rationale / comments as to why the record was rejected or backed up. This then becomes valuable information to the individual(s) and/or department working within the record as they gain insight as to what is needed to progress the record toward approval / closure. Additionally, this becomes valuable to the Quality unit to determine if the record was revised appropriately when reviewing the record a second time.

One of the best attributes to a well developed electronic quality system, besides easily gathering, storing and retrieving data in a consistent and integral manner, is the ability to use automation where appropriate. Automation can be applied from simple calculations to processing records through specific workflow(s) based on pre-defined criteria and input. A useful application of automation is having the system send out notifications when records are coming due or for those records that have gone overdue. You could then develop the system to automatically generate a memo as to the status of those overdue records, while capturing other milestones periodically. You could also develop your system to automatically calculate due dates based on the date the record was created, or develop your system to automatically run reports and subsequently e-mail those reports to a distribution list of individuals.

Consider having the electronic quality system notify the appropriate individuals, groups, or departments at the appropriate times about the progression of the record through the workflow. For example, when a deviation is initiated, who needs to know about it? Perhaps the Quality unit, the Batch Release unit, or upper management for both the owning and supportive departments? A notification to the Quality unit would be beneficial when a deviation has been submitted for final review / closure. You could develop the system to notify when a deviation is closed, which is beneficial as it pertains to the status of associated batches (i.e. released, rejected, etc. . .). Notifications can be very detailed, capturing specific record information and providing specific instruction to an individual or group. For example, a notification can be sent to the quality representative identified within a CAPA record when it is submitted for plan approval. The notification could state that “CAPA # 12345 has been submitted for plan approval, please review and approve at your earliest convenience.” As a forewarning, the excessive use of notifications generated from the electronic quality system will lead users to become desensitized to them and ignore them in the long run.

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