Life sciences industry

Risk and Safety Management

Suite that supports the planning, management and control of all necessary specifications to ensure the quality and safety of the product throughout its life cycle, from its conception to its consumption, ensuring that the entire production chain is in accordance with the Good Manufacturing Practices (GMP) in accordance with the legislation and certification offices.

 

Modules:

 

HACCP

The Hazard Analysis and Critical Control Points module aims to identify hazards in the product safety management process, and to carry out its control through the definition of the prerequisite programs and their operationalization (OPRP and Sanitization), and the definition of critical control points in the production and separation / preparation process, avoiding the consumer’s health being impaired or non-compliant lots being produced. Its use by a multifunctional team, coupled with the Process Flow module, makes it a powerful tool to meet the highest standards.

 

PRPs and OPRPs – Sanitation and Hygiene

The PRP’s and OPRP’s modules are composed of the documentation of the Prerequisite Program (PRP), and its operation (OPRP and Sanitization), aiming to control the basic conditions of the activities necessary to maintain a safe environment throughout the Production process, aiming at the supply of products safe for human or animal use. It allows a complete documentation (audit trail) and validity / periodicities control, working integrated to the Training Management module, preventing unqualified people from executing processes / procedures that put the quality of products produced at risk.

 

Change Management

The Change Management module allows a structured approach, ensuring compliance and ensuring a seamless and integrated implementation of the changes. It is designed to manage every aspect of the change management process from its initial request, which can come from the customer, the supplier or an internal member of the company. Through a thorough record of all stages of change, it identifies the affected documents, planned projects, and action plans, triggering the appropriate individuals for approval, and monitoring all associated activities until the full implementation of the approved changes. It also allows you to execute changes in parallel, making them to be made faster.

 

Qualification, Validation and Revalidation

This module aims to manage the processes of qualification of equipment and facilities, validation of processes and their revalidations, documenting processes and procedures (ex:  Master Validation Plan), storing their records (audit trail) and controlling the periodicity of the same. This module works integrated to the modules of Change Management, Training and Management of Nonconformities – corrective / preventive actions.

 

BOM – Bill of Material

The purpose of the Formula/BOM (Product Structure) module is to provide a detailed record with information on all components, raw materials and items used to obtain a product, identifying all the precedence and correct quantity relationships for each item required. This module can integrate with the customer’s ERP.