Peracto Validation Solutions

Life Cycle Management

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The life cycle concept can be defined as an approach that begins with the identification of a customer's requirements, continues through design, commissioning, qualification, control and maintenance of the chosen system, and ends only when commercial use is discontinued

Let Us Help You

We have a proven track record of system life cycle management from concept through to decommissioning activities

By using Peracto, you can expect high quality organisation and planning of your projects which is critical in preventing small glitches and unforeseen circumstances from becoming major catastrophes. This will further help you in ensuring that your systems are delivered on time, on budget and to the correct quality standards

A brief insight into our approach:

User Requirement Specification URS Review

We will work with you to develop a URS that accurately reflects what kind of system you require based on categorisation into Critical, Important and Desirable requirements

Risk Assessment

We will work with you in answering the following questions,

How much validation is required?

What aspects of your system are critical product & patient safety?

What aspects of your system are critical to the business?

Writing the Validation Plan

We will work with you to accurately define the plan and advise on the specific validation requirements for your system. Our plans ususally define:

Roles & Responsibilities, Organisational Structure, Validation Strategy, Validation Deliverables, Acceptance Criteria, Document Management and Maintaining the Validated State

Preparation of the Project Plan

We will produce an accurate project plan, agreed with you accurately detailing timelines, activities and milestones. We will fully manage this plan and effectively communicate progress and issues to key stakeholders in the designated project team

Equipment Qualification

Issuing the Final Report

The final report will summarise all deliverables and validation activities, providing evidence that the system is validated

Maintaining the Validated State

Through our Revalidation and Recertification strategies we will periodically review and evaluate whether your system is operating in accordance with your company policies and regulatory guidelines