Monsen Engineering Company

Fairfield

y

Princeton

y

Suffern 888-2MONSEN, www.monsen.com

Project at a Glance

Design Criteria:

Achieve 21 CFR Part 11 Compliance

Systems:

Andover Contr ol Systems – Continuum

Invensys -- Wonderware

Time Frame:

40 weeks

More Info:

Bill Lodato (blodato@monsen.com)

Digital Controls Achieve 21 CFR Part 11 Compliance and Save Money

Our client, a pharmaceutical

manufacturing facility, conducted an

internal regulatory audit of its Andover

Building Automation System (BAS). From

the audit, they discovered a need to

improve their data storage, data retrieval,

and process controls systems. In addition,

the audit showed that they were not

compliant with new FDA Electronic

Signatures mandate regulations.

Two Projects, One Solution

Monsen’s Building Automation Group

joined the client’s facility and quality

groups to form a project team. We

developed a solution that would

combine the process control and HVAC

control compliance issues into one

project. By integrating the Andover BAS

into an updated Wonderware “In Touch"

Supervisory Control and Data Acquisition

System (SCADA), we could leverage

their original investment in both

technologies while making the system

compliant with 21 CFR Part 11.

We had 40 weeks to complete the

project. Monsen was responsible for

writing and designing detailed

regulatory documents, implementing

computer upgrades, and maintaining

project change controls. To expedite the

project and minimize its disruption to

the company’s productivity, we performed

most of the development and qualification

testing off-line.

The existing Wonderware Industrial SQL

Server, Terminal Server, and In-Touch MMI

system were upgraded with full 21 CFR Part

11 compliance features. An OPC server was

installed in the BAS network to allow a

precise read/write connection with the

SCADA system. And an Andover workstation

was installed as a backup to help maintain

proper program codes.

The Building Automation System: After

Both the BAS and process control system

were brought into compliance under one

database. Irregularities are now reported

directly through the client’s network, e-mail

system, and PDA devices. Alarm and data

trend reports are available to facilities and

management personnel through the

company’s intranet. Standard operating

procedures record all investigations,

operator actions, maintenance procedures,

and program changes. Most important, 21

CFR Part 11 compliant security models

assure data integrity.

As a result of streamlining two major

projects, Monsen helped this pharmaceutical

manufacturing facility achieve FDA

compliance and lower its cost

of operations.

Compliance Through Automation