Malcom Associates consultants developed the documentation and workflow simplification process in 1987 for migration to electronic batch record (EBR). Malcom’s experienced consultants have performed and implemented hundreds of batch record and SOP simplification, data integrity improvement, and migration projects for life science clients.
Malcom’s proven approach and methodology improves data integrity, reduces human error, improves documentation and workflow ‘best practices,’ and builds the road map for migration to EBR. We assess, develop, test, and IMPLEMENT our solutions with achievable, measurable, and tangible results, on-time and on-budget.
Our simplification solution is easy to follow, easy to understand, easy to complete, and simplifies the review of manual and automated batch record data.