EBR Consulting will help your organization achieve full compliance in the following areas:
Work Instructions — provides real-time verification of operating instructions and parameters and collects manually entered data as well as electronic data captured from PLCs, DCS, MRP, etc., as part of the electronic batch record.
Standard Work Instruction Objects — such as charging materials, line clearance, verification of equipment, and other work activity steps can be quickly developed into computer guided instructions.
Verify Material Status — Material status is verified within EBR by scanning the component and checking the inventory or ERP/MRP system.
Forced Sequencing — Work instructions can require forced sequencing, mandatory field completion, and electronic signatures as well as providing the flexibility for deviation handling, and reporting. Each transaction is date/time stamped for batch record reports and auditing.
Real Time Performance and Monitoring — Transactions can be viewed by work centers or lot and are monitored in real time; providing the ability for real-time performance monitoring. Personnel Training Verification — ensures the user’s training records for the current task are up to date.
Equipment Verification — Rooms, instruments, equipment and parts can all be verified prior to use, via operator instructions and sequence control.
Operator Qualification Verification – Training records, educational suitability, shift suitability can be verifies via link to HR module of SAP.
Material Integrity to Lot/Order — Material in the system is tracked by container through all operations. Unacceptable containers, e.g., expired, unallocated, wrong material, etc., are rejected. Work instruction execution ensures forced sequencing of the correct material in the correct quantity.
Verify Material ID —Material identification is constrained by unique container identification tied to lots and orders. Material charged against an operation is verified as the correct material and correct quantity through bar code scanning.
- 21 CFR 11 (Electronic Records & Signatures)
- 21 CFR 210/211 (cGMP Activity Management)
- 21 CFR 820 (CAPA)
- 21 CFR 1301 (DEA Chain of Custody and Material Reconcil
Shop Floor Environment:
- Equipment validation & verification
- Operator training and suitability verification
Validated Master Data & Change Control
- Validated master data across multiple information systems
- Strict ddhereance to change control policies
- Perfect harmony between prcess integration and compliance