Batch Record Simplification
- reduce human errors
- improve data integrity and workflow
- define guidelines and documentation requirements
- respond to remediation commitments
- prepare for audits
- prepare for PAI
- develop EBR/MES URS
- simplify and support EBR/MES deployment
- support data collection and monitoring implementation
- develop documentation for new products
- develop documentation for product stability runs
We perform a comprehensive assessment and redesign of the batch record documentation (manual, electronic, and hybrid data capture points) to identify data integrity issues, compliance gaps, non-value-added steps, systemic issues, and workflow opportunities.
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.
Elements of Process & Data Integrity
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.
Impact of Malcom’s Redesign Solution:
Percent Reduction
| 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% |