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January 20, 2022

In a previous post on equipment qualification and validation, we outlined how this process works and its importance in Good Manufacturing Practices (GMP) manufacturing. In this post, we learn about how qualification and validation requirements apply to the computer systems that support GMP manufacturing.

What is Computer System Validation?

The Quality team oversees computer system validation to verify and document that a computer system meets its functional purpose and conforms to regulatory requirements. Computer systems are validated in accordance with Good Automation Practices Version 5 (GAMP®5). GAMP®5 is outlined in a document published by the International Society for Pharmaceutical Engineering (ISPE) and provides a set of guidelines, not regulations. One of the main benefits of using GAMP®5 is that it ensures that every step in the system is validated, allowing for deviations to be pinpointed. Computer systems in a GMP setting are also designed based on regulations, like 21CFR11, set by the US Food and Drug Administration (USFDA), for electronic records/signatures.

What Are the Benefits of Having a Validated Computer System in Your GMP-compliant Facility?

There are two main benefits of having a validated computer system:

  1. It prevents human error in documentation, reduces the incidence of non-conformance, and ultimately saves time.
  2. It reduces the use of paper in a clean room setting to cut down on particulate matter in the air.

Process for Implementing a Validated Computer System in a GMP-compliant Facility

The validation process will vary depending on the system, and the time required for validation will be unique for each facility. In general, this process can take months and sometimes years.

Here are the main steps:

  1. Establish a validation master plan: this plan will be created based on user requirement specifications (URS) and functional requirement specifications (FRS). It will lay out a list of activities carried out as part of the validation process, including test cases and the teams involved.
  2. Establish a validation project plan: a sub-part of the validation master plan, the project plan is made up of policies and standard operating procedures (SOPs), along with deadlines for their completion. Before the project plan can be established, all SOPs that will govern system operation must be created, including but not limited to change management SOPs that will be used for system maintenance.
  3. Test cases for IQ, OQ, PQ: this step is needed to determine if the system is fit-for-purpose and will operate as intended. As with equipment validation, operational qualification (OQ) determines that the system meets URS. OQ determines the capability to meet operational parameters and the risk level of deviations, and how critical they may be. Performance qualification (PQ) is also known as user acceptance testing and determines whether the final configured state of the system is acceptable.
  4. Training of end-users: all users must receive training, but training is restricted to essential documents for individual users, depending on their access level.
  5. Ongoing maintenance: following implementation, the system must be regularly maintained. Any updates or fixes must be implemented via a change control.

How Validated Computer Systems Drive Quality in GMP-compliant Facilities

Regulatory requirements for long-term data storage (up to 25 years) have led to advancements in data management that help to build systems with long-term stability. The continued use of computer systems in manufacturing will drive further technological advancement and highly automated compliant processes with efficiencies.

Contact us to learn more about our GMP-compliant facility and how it can support the manufacturing of your CGT.

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