Change is an inevitable consequence of innovation and improvement. Changes may also be required as a result of corrective or preventative actions or as a result of process and product monitoring. The Change Management System ensures that changes are carried out in a controlled, effective and timely manner and that there are no unintended consequences of the change.

PSC can assist you develop and implement an effective Change Management System that ensures that the level of documentation and effort is matched to the level of risk associated with the change. Specifically we can assist you:

• Develop a Change Management System that is linked to other Quality Systems such as CAPA, Customer Complaints, Validation, etc.
• Develop criteria to evaluate whether changes affect a regulatory filing.
• Develop evaluation criteria for determining if changes are technically justified.
• Develop procedures for confirming that the change has occurred, the objectives were achieved and that there were no unintended consequences.
• Develop a change management tracking system to facilitate effective Change Control Board meetings.

If you have a need for our Change Management System services, please Contact Us.