PharmSys improves our client's manufacturing operations by providing management tools for controlling and monitoring many internal business processes. These process management tools help our clients achieve greater manufacturing reliability thereby enhancing their operational effectiveness and quality control. We provide services to aid with the development and implementation of the technical aspects of operations management with which an organization may have limited or no experience.

The focus of our operations management consulting is directed at the refinement of our client's quality systems for controlling production, engineering and maintenance activities. The identification, measurement and analysis of key performance indicators (KPIs) and process acceptance parameters are fundamental to our approach. We draw upon our extensive experience working with many organizations to provide solutions consistent with industry standards.

Our solutions result in new and/or improved process management tools that will help our clients to:

• Gain or maintain a competitive edge.
• Increase production efficiencies and yields.
• Meet regulatory compliance guidelines.
• Improve their bottom line through more effective control of their internal operations.

Several operational business processes that will benefit from our services include:

Change Control - We generally utilize our client's existing change control processes for implementing changes to their equipment, systems or manufacturing processes. Occasionally our clients do not have a formal change control system in place. We help them to understand the benefits of this management tool and provide assistance with its development and implementation.

Functional Management Systems - PharmSys offers consulting services to help our clients design and implement a variety of functional management systems. We have experience developing database systems for managing functional activities such as validations, preventive maintenance and metrology (instrument calibrations). We have also worked with our clients to develop systems for continuous, centralized monitoring of plant operations. These functional management systems result in:

• Streamlined operations and management oversight.
• Enhancement of process repeatability.
• Greater quality control.
• Improved regulatory compliance.

Graphics and Schematics - We strive to demonstrate the value of graphical representations to our clients. Our services include the development of graphics and schematics depicting our client's as-built facilities, manufacturing systems and processes. Comprehensive graphical productions include digital photography, CAD-based technical schematics and a variety of software tools for developing flow charts, visualizing data trends and performing process analysis. Graphical representations greatly aid activities such as:

• Troubleshooting and maintenance.
• Process flow and cycle optimization.
• Process acceptance.
• Space management and plant floor utilization.
• Engineering and validation studies.
• Regulatory presentations.

Organizational Structure - We supplement our client's existing operations management team in this area so they can remain focused on maintaining their daily site operations. PharmSys aids with the development of:

• Departmental responsibilities and boundaries.
• Employee job descriptions.
• Personnel and functional organization charts.
• Manufacturing system ownership.
• Cross functional reporting.

Process Management - PharmSys provides valuable assistance to our clients for optimizing their business and manufacturing processes. The results of our work include greater operational reliability and increased production efficiency. Process performance is monitored and benchmarked by evaluating a variety of key performance indicators (KPIs). We draw upon our extensive business management experience and engineering abilities for identifying, tracking and analyzing our client's process data. Bottlenecks and sources of high risk or inefficiency are clearly identified from statistical evaluation of this data. The final steps are to design and implement solutions that will enhance our client's processes and optimize performance.

Specifications and Test Protocols - Our comprehensive project management services include preparing detailed specifications and test protocols for facility expansions and manufacturing system upgrades. We generate detailed documents for our clients, including:

• User requirements.
• System specifications.
• Factory/site acceptance testing (FAT/SAT) protocols.
• Commissioning testing protocols.
• Installation, operational and performance validation protocols (IQ, OQ, PQ).

We assist our client's personnel who may not possess adequate experience with complicated manufacturing systems by providing technical documents based on sound engineering principles and meaningful test parameters.

Standard Operating Procedures (SOPs) - PharmSys will help your business develop SOPs governing:

• Overall plant operations.
• Production processes.
• Facilities management.
• Engineered systems operation.
• Quality control activities.

We often generate new or revised SOPs in conjunction with our project management, engineering and validations services. SOP content is developed in accordance with our client's established documentation system for compliance with current Good Manufacturing Practices (cGMP).