How do you automate tasks using GMP quality system software?

Software has all features prescribed in approved URS with flexibility of update as per new requirement arise. Must have multilevel security feature so that various group can operate without messing up the equipment setpoints, recipes and ranges.

This is a crucial phase in the process of finalizing GMP/GxP software, as GMP software requirements can essentially be categorized into two distinct parts: business process requirements and compliance requirements. Additionally, it is imperative to factor in the associated costs when making your software selection. There are two pivotal steps involved in this process: firstly, the analysis of requirements, and secondly, the assessment of both vendors and software options, as outlined in the 3A 3C Approach reference.

The most important aspect of finalizing a software for the business requirement for the GxP activities is the User requirement specification. How the URS is designed considering all business, quality, compliance, safety and IT infrastructure related requirements decides the success of the automation. Another important aspect of automation is functional risk assessment that helps to identify the risks associated with the implementation and the technical and procedural controls for meeting the compliance and business requirements.

With this it is important to reflect on your current software, if there is any I use, and look for a package with the software vendor where the base holds most, if not all, the necessary features. Don't fall into the pit of thinking you can customize afterwards, only to find out that it is either prohibitively expensive, or not possible with the frame work.

When selecting software for GMP operations, there are several key considerations that organizations should keep in mind. These include compliance with regulatory requirements, validation to ensure that the software performs as intended, security to protect against unauthorized access, user-friendliness, data integrity, flexibility, and ongoing support and maintenance. Choosing software that meets these considerations can help organizations ensure that their GMP operations are in compliance with regulatory requirements, while also maintaining product quality and patient safety. As the pharmaceutical industry continues to evolve, selecting the right software will remain essential to achieving these goals.

Once you've chosen the software and vendor for automating a GxP process, be sure to adopt the software carefully according to User requirement specification (URS). During this stage, you should think about these tasks: installing the software as per the vendor's design spec, configuring the application, and validating it against the URS. it is recommended to use the GAMP 5 framework to validate the software and ensure it stays compliant throughout its life cycle. Also, CSA approach can be adopted to reduce the validation efforts.

Configuring the software is something that requires careful consideration. For example, how much 'out-of-the-box' configuration can we use versus how much do we want to configure this system so that it works the way we worked prior to having the system? The introduction of any new computerised system is an opportunity to improve effectiveness and efficiency. Automating a bad process will lead to a bad automated process. It is wise to consider what process improvements can be made and be open to changing your process to get the best out of the system.

The success of the training program of a new software depends on how easy the interface and user friendly the software is. Complex operations may frustrate the user resulting into more human errors that would impact the successful automation plan.

This step shall also consider helping users to adapt this change from manual to automated processes. This transition has to be managed well for the success of the process automation.

Along with the performance, It is very important to maintain the compliance of the GxP application throughout its life. However appropriate procedure controls should be placed during the adoption phase itself. the following controls are crucial to monitoring compliance. #periodic review #audit trail review #data backup and retrieval #password compliance #data integrity compliance #self-inspection and other applicable controls These procedures are very crucial to avoid major audit observations.

Before updating any feature, it is important to follow the change control procedure to check the impact and to conclude validation efforts. It is recommended to have an appropriate procedure for patch management, change management, and configuration management.

Along with the above steps, Validation shall be included after choosing the software. GAMP 5 framework shall be used for validation i.e. CSV.