The comprehensive assessment may also include elements of the process and supporting interfaces where additional data integrity, workflow, compliance, and systemic opportunities may be identified.
Our consultants work closely with the client subject-matter-experts (SMEs) to understand the current processes, systems, and workflow to develop a simplified batch record design that reduces human errors, data redundancies, and non-conformances. The batch records developed are ‘live tested’ during actual production runs to confirm the changes, workflow, and ease of use by the SMEs.
Malcom’s redesign ‘best practice’ solution simplifies process and data workflow making it easy to follow, easy to understand, easy to complete, and easy to review paper based and automated batch record data.
|Pages||20 – 35%|
|Data Entries||30 – 60%|
|Documentation errors||50 – 70%|
|Review cycle time||40 – 60%|
|Manufacturing cycle time||10 – 15%|
|Time spent on investigations||20 – 30%|