BSM have just launched their latest Management Briefing - LEANING THE BATCH RECORD PROCESS.
This briefing addresses the issues and problems often associated with manual Batch Records, including long review and approval lead-times and poor 'first time' document accuracy.
Life Science Manufacturing has always put significant effort, resources and cost into its manual batch record processes. Despite this, Right First Time performance and lead-times are almost universally poor. Occasional improvement initiatives may lead to temporary improvement but performance generally returns to former levels once the focus is "off". What is needed is a more radical approach which re-engineers the fundamental processes (and the batch record) based on key Lean Principles. Batch Record processes are not the same as manufacturing processes and careful adaptation of the Lean techniques is required.
BSM is a leading management and technology consulting company specialising in the life science sector. We assist companies to deliver significant measurable improvement across a range of manufacturing, testing, documentation and business processes. We work in Ireland, the UK, Europe and the US with some of the world's best companies.
If you would like to download a free copy of this report please visit the Publications section of our website.
If you would like to discuss your own batch record project or plans in more detail please do not hesitate to contact:
Tom Reynolds
Tel: + 353 (0) 91 746900
E-mail: tom.reynolds@bsm.ie