sai logo

BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING

BATCH RECORDS - SAI MEMBERS HAVE WRITTEN MORE THAN:

2500 Solid Dose Batch Records (BRs) i.e. tablet, capsule, IR/DR, spheres

1500 Liquid BRs

400 Semi Solid BRs

25 Vaccine Product BRs

>50 Biological Products

>5000 Medical Devices BRs

View examples of SOP video

video SOP




SOPs – SIMPLIFICATION & OPTIMIZATION

Challenge the Architecture

Consolidate, delete, combine, etc.

Scalable Best Practices

Better use of pictures diagrams, tables

Reduce Text

Make more clear & usable

Aligned to BRs

LOG BOOKS

SAI has implemented industry tested Log Books and begin with models for examples

VIDEO PROCEDURES

View a better way to reduce a >35 page SOP that is often used and monitored

Great training reinforcement tool

Demonstrates to Regulatory Agencies
(innovative improvements)