Compliance

Ensuring compliance with regulatory requirements

Apart from the typical challenges that come along with global competition, companies operating in regulated industries must comply with additional requirements. These include, for example, the dual control principle for certain interactions with IT systems or the explicit authentication of users. Requirements of this kind derive from regulatory guidelines such as GxP, GAMP 5, FDA 21 CFR Part 11, or ISO 13485. Such requirements are designed to ensure both data integrity and the secure execution of processes. Depending on the industry, people’s health or even their lives may depend on whether all regulatory requirements have been met and data in the manufacturing IT system is accurate. 

You can use the features of the MIP add-on Compliance in a variety of ways, such as approving inspection results by two different qualified employees or documenting deviations from the standard process. In addition, the execution of certain actions can be verified through a four-eyes approval process. To control this workflow, the MIP add-on uses a feature known as recording of signatures, which is also referred to as double visa or multi-level approval. 

This dual approval process can be synchronous (both users on the same input device and one after the other) or asynchronous (users on different devices and at different times).

Your benefits

You can ensure compliance with requirements for specific activities in a regulated manufacturing environment, thereby enhancing data integrity of your manufacturing IT. This supports the validation of processes and IT systems in regulated industries.

Technical information

The MIP add-on Compliance is part of the category Regulatory & Compliance Management of HYDRA X for Process.

The MIP add-on extends the features offered by MPDV's Manufacturing Integration Platform (MIP).

Compliance in the MIP ecosystem

You can use the dual control principle in many manufacturing IT applications to ensure that approvals and actions are properly verified. For this purpose, MPDV offers the following mApps:

• In-production Inspection: Perform in-production inspections.
• Complaint Management: Efficiently process complaints.
• Maintenance & Service Management: Manage maintenance of resources.
• Work Order Execution: Collect order data on the shop floor.
• Compounding: Ensure accurate weighing, dosing, and mixing.

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