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