How Pharma industry can resolve compliance issues with Pharma ERP?

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Concerned about receiving an FDA 483 letter? It is very common because you are not alone in this. Regulatory compliance pressure in Pharmaceutical industry It has never been more dangerous. However, the best time to comply with quality cGMP is before you feel the consequences of a failed scan. The best way to ensure you don’t get a 483 is to understand the most common compliance issues in the pharmaceutical industry so that you can focus on those areas and solve them easily.

Let’s look at the top three compliance issues and how you can solve them:

Lack of written procedures and standard operating procedures

In the Standard Operating Procedure (SOP), clear stages are defined for completing specific tasks in the workshop. Proper use of standard operating procedures improves communication and facilitates the performance of tasks necessary to move the business forward. However, compliance issues tend to arise due to the lack of effective written standard operating procedures/procedures. In addition, various problems prevent the creation and use of standard operating procedures, including complex language, lack of standardization, and insufficient training.

Poor maintenance facilities

Most of the FDA’s observations were regarding inadequate cleaning, sterilization, and maintenance; They must comply with FDA law for federal regulations appropriately. The company must clearly define the methods of cleaning and maintaining sanitary conditions. For example:

  • Give clear instructions for cleaning.
  • Indicating who is responsible.
  • Plan your cleaning schedule.
  • Provide instructions for proper maintenance of equipment.
  • Ensure regular inspections and preventive measures for equipment.

In addition, it is important to keep records of cleaning activities and update them as often as other operating records.

Improper use of data

Real-time access to data allows pharmaceutical companies to stay on top of changes in compliance and improve performance. By using appropriate data, an organization can effectively reduce the effects of non-compliance. Unfortunately, one of the main reasons organizations cannot use the available data is outdated technology.

By implementing a pharmaceutical ERP system, pharmaceutical companies can track and trace data in real time and can reduce the impact of non-compliance. to implement Pharma Microsoft Dynamics 365 Business Central Empower your teams to achieve desired results by better managing these complex factors while maintaining strict industry guidelines and best practices.

Pharma ERP Partner, metapharma It is an ERP solution for the pharmaceutical industry built on Microsoft Dynamics 365 Business Central. The Pharma ERP solution is demanding companies, making FDA compliance much easier. High-priced paperwork errors can be reduced, as can the number of recalls that can be avoided.

For more information and details proof Call us today at MetaOption.

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