| Validation Services / Documents:
(PLC, Global system (LIMS, MES, MRP), Facilities/utilities, Equipment, and Process Validation)
User Requirements Specifications:
A document created to define the needs of the user group. Focusing on 'what' objectives need to be achieved.
This document is linked to the acceptance criteria of the Performance Qualification activities.
Functional Specifications:
A document created to specify a function that a system component must be capable of performing. Focuses, generally,
on 'how' user requirements must be achieved. This document is linked to the acceptance criteria of the Operational Qualification activities.
Master Validation Plans:
A plan created to define validation approach, activities, responsibilities and associated procedures.
Installation Qualification Protocol:
Documented verification that all key aspects of software and/or hardware installation adhere to appropriate procedures and design intentions and
that the recommendations of the vendor have been suitably applied.
Operational Qualification Protocol:
Documented verification that the equipment-related system or subsystem performs as intended throughout entire operating range.
Performance Qualification Protocol:
Documented verification that the process and/or total process-related system performs as intended throughout the normally anticipated operating range of use.
Validation Summary Reports:
A concise representation in summary form, of all validation activities conducted within the scope of the protocol or plan. The summary report
contains a synopsis of all test results and findings, indicating whether or not objectives were met.
Compliance Services:
(Internal or Regulatory)
Vendor Audits:
An activity conducted to determine thorough investigation of, and adherence to, established procedures, instructions, specifications,
codes and standards or other applicable contractual or other applicable requirements.
Documentation Audits (Gap Analysis):
An activity conducted to determine through investigative measures, the adequacy of, and adherence to, established procedures, instructions,
codes, specifications, and standards.
System and Process Audits:
An activity conducted through evaluative measures in order to determine, the efficiency of systems and processes.
Site Audits:
An activity conducted through evaluative measures in order to determine adherence to local SOPs and mandates.
Business Services:
Project Plans:
Definition of scope, task identification and sequencing, resource identification, planning and tracking, cost estimation and budget reporting,
validation integration.
Risk Assessments:
Risk occurrence categories (remote, possible, likely) presented in a matrix with risk impact(low, high, severe).
Infrastructure Services:
System Development and Implementation:
Assistance in: determining user requirements, vendor selection, communicating requirements to vendors/developers,
system construction/development, implementation and user training.
Technical SOPs:
Standard Operating Procedures developed for users of systems, processes or equipment.
Change Control Policies and SOPs:
Systems and Standard Operating Procedures designed to ensure the continued demonstration of control of validated systems, equipment and processes.
Validation Policies and Guidelines:
The general principles of validation detailed in a policy statement applying to services provided by external consultants, the internal
validation department of a single site, or across an entire corporate entity. These services may apply to equipment, hardware, software,
computerized systems, utilities, procedures and processes associated with the manufacture, holding and/or packaging of any drug or food product.
Training SOPs:
Standard Operating Procedures designed to implement and document initial and continuing training for users of systems, processes or equipment.
Training Programs:
Assistance developing and implementing all areas of training programs, including, policies and procedures, manuals and delivery.
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