Implementation & Validation Philosophy:
Since HPFM specializes in the implementation and validation of LIMS and other computerized systems in pharmaceutical/bio-technology companies, we concentrate on aiding clients in designing and documenting their implementations to withstand the rigors of FDA's regulations and inspections.

Demonstration that an application 'performs as intended' at the moment of implementation is insufficient to meet current compliance requirements. The firm also must demonstrate consistent and continuous control of the system.

Approach and Services:
HPFM's approach to implementation and validation of applications encompasses their use across the organization, with the goal of demonstrating and enforcing a state of continuous control, as well as providing a framework for efficient execution of the work of the organization. Thus, all aspects of the application's use in the organization are included:

Implementation Strategy & Planning
Define those areas of the organization's work which will have the greatest return on the investment of resources required to implement them. Plan the phases of implementation, the tasks and time to completion, and the resources required.

Configuration
Design and document data definition, work processes and testing structures which will assure the system captures data in a manner appropriate to its later retrieval for reports and statistical analysis.

SOP's
Determine that all SOP's necessary to control the system and its use in the organization exist, are complete, current and are consistently followed.

Training
Document user training on the application and on the SOP's to assure that the system is used as intended.

Validation & Documentation
Document that the system performs as intended and AS CONFIGURED within the functional units it serves. The Validation Plan includes a listing of each piece of required documentation, its purpose, and its reviewer and approver, so as to provide a complete picture to an auditor. The Plan is typically divided into IQ, OQ, and PQ stages, each of which may be separately approved before each stage is executed.

Retrospective Data Analysis and Reporting
HPFM has developed SAS-based data analysis systems for retrospective review of product release and stability data, to meet FDA's requirements for annual product reviews. In addition, we develop custom analysis systems using SAS. These systems allow users who are not SAS programmers to analyze their data using tools that can be validated.