Why Choose TiPS?

LogMate is the most reliable, proven software solution since 1990

    • Leadership Participation in Alarm Standards Committees
    • Dedicated Alarm Management Focus
    • Comprehensive Alarm Management Software Solutions
    • Adaptable Services Model
    • Flexible and Extensive Software Connectivity Portfolio
    • Broad Industry Experience

LogMate® Is The Prescription For Reliable,
Effective Alarm Management

Pharmaceutical

Many of the alarm management issues in the pharmaceutical industry like nuisance alarms, alarm floods, alarm chattering, and related alarms are similar to other process industries. However, the pharmaceutical industry also has many unique challenges that must be understood and planned for when implementing alarm management. Some of these include 21 CFR Part 11 requirements, stringent validation processes, and the expectation to embrace current good manufacturing practices (cGMP).


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Common Pharmaceutical Challenges

    • Many different alarm sources and interfaces between building management and process systems with no standardized view
    • High total cost of ownership due to validation and documentation requirements
    • Limited alarm data accessibility and ineffective tools for production event investigations
    • Hesitancy to update alarm settings because of management of change complexities and workload priorities


TiPS Pharmaceutical Solutions

    • Broad, established connectivity portfolio and supplementary custom connectivity integration services
    • We use standard technology and interfaces to reduce costs and simplify maintenance
    • Advanced visualization and analysis tools available through standard web browsers that simplify event investigations
    • LogMate’s ACE module supports alarm configuration management of change



User Scenario

A recent FDA audit has resulted in a Form 483 submission that identifies opportunities for quality improvements in a pharmaceutical manufacturing facility. After having a meeting with production and engineering, the assigned investigation team determines that the large number of alarms inundating the control room operators, when process upsets are occurring, is contributing to the quality issues. The alarm floods result in delayed corrective control actions by the operators as they evaluate, prioritize and process the alarms.

The quality assurance engineer and other process engineers have limited access to the alarm information at the control system level and were not previously aware of this correlation. Alarm management is recommended to help address these operational concerns. Several criteria are deemed critical to selecting the right alarm management software:

1. Proven connectivity to several different building management and process control systems.

2. Consolidated view of alarms available through standard web browsers to improve accessibility.

3. Technology supports 21 CFR Part 11 compliance with electronic signature, audit trail and data integrity requirements.

4. A low total cost of ownership employing standard interfaces and technologies.

5. A product with a proven history of validation implementation for pharmaceutical process systems

After evaluating several alarm management software packages against these and other criteria, they determine LogMate is the best choice. Contact us now to find out more about TiPS’ pharmaceutical solutions.

LogMate reduces the burden on operators by resolving alarm issues.

Pharmaceutical manufacturers are under constant scrutiny from government agencies as well as public interest organizations. Pressure has never been higher to require a practical guarantee that your products meet or exceed specification. LogMate can help protect batch quality and accelerate the process of a variance or incident review to get you back into production as quickly as possible.

TiPS has many long-time pharmaceutical clients. We understand the industry’s regulatory environment and continue to develop successful solutions to meet your industry-specific challenges.

Learn about LogMate’s 21 CFR Part 11 capabilities >>

Learn how TiPS supports validation >>