LíderCyA

Methodology

Developing Systems Integration Projects Under a Standardized Methodology such as GAMP 5 (Good Automated Manufacturing Practices - ISPE 2008), reduces deviations and brings us closer to the stated objective.

In addition to the Technical Capacity and Innovation for the Success of a Project, we offer the management of "Good Practices of Project Management and Businesses", which turns us into a Systems Integration Services Engineering firm, allied with its operations of production.

Líder has adapted its own methodology to carry out Automation Projects, the applicable international guidelines and standards, which allows us to have a common language of understanding with both clients and suppliers to deliver our projects with quality (time and manner) and agreed budget . Even with any deviation or change, this method allows us to trace the changes and manage them for risks controlling their solution to guarantee the success of the project.

Next, we describe the general deliverables of the Project Life Cycle:

 

0.  Planning

This stage is determined by the user of the automation, where the business organization has decided to solve a problem, for example, increase productivity, control the safety of production processes, increase the availability of operational equipment and improve the quality of the products and services, etc. This guideline, which must be expressed in writing, will be the basis for developing the Automation Project that meets the solution of the problem, for which its development is described with the following deliverables:

 
 

1.  Specification of User Requests (URS)

This document establishes the technical, functional and business requirements for the Customer Plant. Outline the General Design Philosophy, listing each of the performance requirements that the System must meet.

 

2.  Specification of Functional Requiriments (FRS)

It details the interface and functionality requirements of all Hardware and Software required for the application that will determine the operation of the system.

3.  Detailed Design Specification (DDS)

The Detailed Design Specification (DDS) will form the basis of the implementation for its installation and integration.

 

4.  Risk Management (RE)

It is the global process that consists of a Risk Analysis and Evaluation, where the Risk Analysis is the systematic use of the information available to identify hazards and estimate the risk, and the Risk Assessment is the judgment, based on the risk analysis , that a risk has been achieved that is acceptable in a given context. The Risk Assessment is in the context of the Risk Management, where the Client would correspond, apply the Controls derived from the evaluation to eliminate or mitigate the risks and their corresponding Monitoring to keep them under control.

 

5.  Installation Qualification (IQ)

The Installation Qualification (IQ) will documentally test the Control System Installation. During the IQ a Test Protocol will be executed for approval. The protocol will test all hardware input and output devices and their functionality. The elaboration of the IQ Protocol will be done by the client, as well as its execution (Validation).

 

6.  Operation Qualification (OQ)

The Qualification of the Operation (OQ) will test the functionality of the Modules (hardware and software), their integration, their interoperability and sequence. The elaboration of the OQ Protocol will be done by the client, as well as its execution (Validation).

 

7.  Performance Qualification (PQ)

The Performance Qualification (PQ) will test and confirm that the system is capable of and complies with the control and performance of the activities of the processes in the operating environment that are required by the user previously in the approved specifications. The preparation of the PQ Protocol will be done by the client, as well as its execution (Validation).

 

8.  Non-Conformities Management (NCM)

The Non-conformities Management (NCM) will summarize the unusual occurrences, deviations and variations of the system with respect to the Validation Plan and the requirements. What will result in a Deviations Remediation Plan, whose responsibility will be Client, which will include corrective actions taking into account the highest possible implications, its follow-up and the procedures to close the cases of deviation.

 

9.  Validation Report (VR)

The Validation Report (VR) will summarize the validation activities, as well as any deviations from the validation plan, the exceptional and corrective actions, and a statement of compliance with the purpose of the system.