What Are the Key Changes to Schedule M in 2025?
With a stronger focus on electronic records, companies must adopt e-BMR (electronic batch manufacturing records) and ensure all data is captured accurately in real-time.
New mandates around environmental controls, including temperature and humidity monitoring, necessitate robust systems for tracking and managing production conditions.
The quality management system requirements have been strengthened, including more rigorous testing and validation procedures to ensure the consistency and quality of pharmaceutical products.
Challenges Pharma Manufacturers Face with Schedule M Compliance
The switch from paper-based records to e-BMR systems poses a challenge for many companies, requiring substantial investment in technology and training.
With stricter data validation and audit trail requirements, ensuring the integrity of electronic data becomes a major hurdle.
As compliance requirements expand, pharmaceutical manufacturers must allocate more resources to quality assurance, testing, and validation efforts, which can strain budgets and timelines.
How Progen’s Compliance Software Helps Pharma Manufacturers
Progen’s system automates the creation and management of electronic batch records (e-BMR), reducing human error and ensuring complete compliance.
Progen’s software integrates quality control processes with production workflows, making it easier to meet stricter quality management requirements.
With automated audit trail capabilities, Progen ensures your company is always audit-ready, maintaining data integrity and compliance with Schedule M’s stringent record-keeping requirements.
