eFlexes - Flexible Engineering Services Ltd

Client : Large Multinational Medical Company

Process Control and Error Proofing Solution

Client Requirement

Our client identified a need to automate the method they used to select a specific program. Errors in the process resulted in missed customer deliveries; wasted manufacturing costs and material scrap costs. The issues that they wanted to address included:

1. Eliminate errors in program selection and validation

2. Eliminate errors in capturing and validating order information

3. Facilitate data capture to ensure a full record or audit trail existed for the operation.

4. Implement changes incorporating requirements from 21 CFR Part 11

eFlexes Solution

eFlexes designed and developed a Visual Basic application to act as the primary operator interface at this process step. The application leverages existing barcoded data on the paper-based product router to enable the operator to accurately and efficiently identify key product attributes. The application automatically validates this data against master data in the company’s ERP application before searching a central machine program repository for the appropriate machine program. The operator is required to verify their electronic signature before the application launches the appropriate machine program in the machine’s host application.

Access control, audit trail and electronic signature/electronic record functionality was included to enable the customer’s process to become fully compliant with FDA 21 CFR Part 11: Electronic Records; Electronic Signatures.

To facilitate process management and control, the electronic product history for this area of the manufacturing process is made available in real-time on the company intranet, using an ASP based reporting engine.

Flexible administration and system configuration utilities were provided as part of the Visual Basic application to facilitate future system or process changes.

Architecture

The solution was built as a Microsoft Access database application, using VBA application code for the user interface

As with all eFlexes solutions this application is easily migratable to other database platforms.

The solution integrates seamlessly with existing in house applications through eFlexes customised interfaces. The application facilitates manual or scanned entry of data and real-time data reporting is available through ASP-based web pages.

Benefits to the Client

The primary benefit has been cost reduction and the return on investment was two months.

Increased yield

· Reduction in the generation of waste product produced, as a result of human error.

· Alerts ensure that incorrect procedures are flagged and action is taken to address issues in real time.

Limit in liability

· Full traceability and audit reporting built into the process.

· Compliance with FDA 21 CFR Part 11.

Increased productivity

· Operator intervention is reduced, freeing up operators to perform other manufacturing duties.

· Only operators that have been suitably trained in the process can use the application,

and all transactions are recorded using electronic signatures.

· A user’s role determines the system functions available.

· Elimination of wasted manufacturing time which resulted in scrap

· Reduction of rejects at pre-shipping inspection due to incomplete records

Customer responsiveness

· Full Traceability for customer queries

· Improved on-time delivery

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