Adequate change control methods for computer systems are essential in the dynamic pharmaceutical sector to guarantee regulatory compliance and preserve product safety and quality. Pharmaceutical firms must grasp the ins and outs of implementing and overseeing change controls as a result of technological advancements and the growing integration of computer systems into manufacturing and distribution processes. The purpose of this blog is to give pharmaceutical laboratories a thorough collection of questions to help them implement computer system change controls successfully within their organizations. By adhering to these rules, businesses may make sure that modifications to their computer systems are implemented smoothly and legally, thereby protecting the integrity of their goods and fulfilling industry requirements.
1. Specify the Type of Change
a. Hardware/ Software/ Other (such as firmware/Anti-Virus)
2. Does the Change require an “Information System Change Management”?
a. Include Copy of ISCM in the supporting Documentation
b. Include reference to the ISCM in the description/justification of the CC
3. Has the request been evaluated by the Quality Assurance Department?
4. Has the request been evaluated by the Technology department?
5. Has the request been evaluated by the Regulatory Affairs department?
6. Validation Recommendations?
- Validation Plan
- Functional Requirements
- User / System Requirements
- Design Specifications
- Factory acceptance test (FAT)
- Regulatory Assessment
- Supplier Assessment
- Risk Assessment
- Traceability Matrix
- IQ/OQ PQ
- Validation Summary Report.
Note: Information System Change Management also known as change enablement—is an IT practice designed to minimize disruptions to IT services while making changes to critical systems and services. A change is adding, modifying, or removing anything that could have a direct or indirect effect on services.
A Factory Acceptance Test (FAT) is a process in which a manufacturer tests a machine or system before it is delivered to the customer.
In software development, a traceability matrix (TM) is a document, usually in the form of a table, used to assist in determining the completeness of a relationship by correlating any two baselined documents using a many-to-many relationship comparison.
After reading this blog, we hope you can understand the importance of change control and properly use the proposed checklist and improve on it further.
Now that you know this:- hopefully you are in position to answer the Assignment(s)
Have you been involved in any change control activities in your lab? If yes recollect your activities?
Does your lab have proper SOP for the implementation of change control in your lab? If so are there effective?
Do you clearly identify whether proposed changed is Critical/Major/Minor? If yes what is the criteria?
Do you clearly identify whether proposed changes effect the quality of the product? Stability of the product? If so then it is properly captured and its impact properly assessed?
What is average time period required to properly close change control in your lab? Can you suggest any 3 measures to improve the quality of change control?
Have you found any communication gaps between different departments to smoothly close change control system?
