Best benefits of pharmaceutical MES for FDA regulatory compliances

BEST BENEFITS OF PHARMACEUTICAL MES FOR FDA REGULATORY COMPLIANCES

R E G U L A TO R Y C O M P L I A N C E 2 1 C F R P A R T 1 1

BEST BENEFITS OF PHARMACEUTICAL MES FOR FDA REGULATORY COMPLIANCES

Pharmaceuticals need worldwide is only increasing every year. Its market share of 934.8 billion USD in 2017 is reaching $ 1,170 billion in 2021 at a CAGR of 5.8 %. With such a rapid rise in the need for pharmaceutical products, pharma manufacturing execution system has become essential. It streamlines the production of pharma products and to bring it to the medical stores in time and with precise quality compliance with all the regulations.

REGULATOR Y COM P LIA NCE 21 CFR P AR T 1 1

Pharmaceutical companies and medical equipment and healthcare services to open shop in the US should undergo regulatory compliance 21 CFR part 11. Brought on 21 March 1997 by FDA or the food and drug authority of the US, it is to regulate the electronic signatures for their signing authorities’ responsibility and accountability of pharmaceutical companies.  FDA first published Part 11 code of regulations to wet signatures of digital documents for security concerns. There were many iterations for managing the distribution, storage, and retrieval of records by pharmaceutical, medical equipment, and biotechnology manufacturers in this digital era.

BENEFITS OF PHARMA MANUFACTURING EXECUTION SYSTEM Deployment of MES as technology started from the FDA's 21 CFR Part 11 regulatory measures.

The Pharma manufacturing execution system now does more than regulatory compliance. For the past two decades, it has evolved to ensure quality, risk management, and mitigation by management methodologies. Â In other words, MES in the pharma sector helps to bridge the gap between case management and regulatory & operational control. MES's benefits could be both quantitative measured by the ROI and qualitative which is subjective but also vital for regulatory compliances and others including:

BENEFITS OF PHARMA MANUFACTURING EXECUTION SYSTEM

• To improve scheduling, process changeover, resource utilization, manufacturing flexibility, visibility, accuracy, and material tracking.

• Reduces errors in record production, WIP or work in progress, production cycles and recalls among others • Enhances PAT or process analytical technology, investigation capabilities, and others • Enforces paperless manufacturing with a sequence of operations with KPI or key performance indicator • • Bar Code India provides the best pharma manufacturing execution system for companies in India and worldwide to comply with all regulations and other best benefits.

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