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 in preparing a URS document that suits your
need based on Critical, Important and Desirable User Requirements. In our experience, an accurately written URS is critical
in adhering to project timelines, significantly during the Qualification Phase.
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
See our Equipment Qualification
Page
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