POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 148

documentation and data. Web-based systems can provide access to project data
from remote locations and can alleviate the issues stemming from global project
team collaboration. The systems should include security administration to ensure
that users have appropriate access to data. Project information management
systems can include online repositories for engineering data that allow users to
maintain engineered system information and provide access to the most current
and relevant project data. They can also include a project library, allowing
users to catalog and classify project change and project documentation as part
of the project life cycle. Systems may allow users to define workflows for
project library items and include e-mail notifications to ensure all project team
members are kept updated on outstanding and upcoming deliverables; and may
include integrated project punch listing, request for information tracking, project
estimating, detailed cost control, and forecasting.
From a commissioning and qualification perspective, when used as the sin-
gle repository of project-related documentation and data, a project information
management system allows users to accurately capture and transfer the informa-
tion needed to qualify and operate systems. This mitigates the risk of corruption
of data that can occur when it passes through multiple levels of handling and
transfer from one user to another.

7.3 IMPLEMENTATION

7.3.1 Risk-Based Qualification Plan
Regulatory guidance recommends the preparation of qualification plans as a
means to perform an effective qualification program. The FDA states in the
2011 process validation guidance that [13]:
Qualification of utilities and equipment can be covered under individual plans
or as part of an overall project plan. The plan should consider the requirements
of use and can incorporate risk management to prioritize certain activities and to
identify a level of effort in both the performance and documentation of qualifi-
cation activities. The plan should identify the following items:

1. the studies or tests to use;
2. the criteria appropriate to assess outcomes;
3. the timing of qualification activities;
4. the responsibilities of relevant departments and the quality unit; and
5. the procedures for documenting and approving the qualification.

The project plan should also include the firm's requirements for the evaluation
of changes. Qualification activities should be documented and summarized in a
report with conclusions that address criteria in the plan. The quality control unit
must review and approve the qualification plan and report (21CFR part 211.22).