Overview
It’s nearly impossible to hit the bullseye in the dart game dart every single time!
But, how about hitting the “Quality Mark” in your process manufacturing business, always?
Imagine a situation where, maintaining quality across a process manufacturing organization is no more a complex task. No more hefty reworks and losses due to poor product quality. The processes are running as per SOPs, every change is monitored and tracked, risk and non-conformances are things of history and delivering top quality products consistently has become easy as pie. Dreamy?
This isn’t a magic, but the power of technology. Adopting a right Pharmaceutical QMS Software can bring this to reality for you.
What is a Quality Management System in Pharma?
A Pharmaceutical Quality Management System is a tool that predominantly automates and manages all the quality operations within an organization. Going by definition, it is a comprehensive collection of policies, processes and procedures that ensure products are made as per the standards appropriate to their intended use.
It helps identify operational defects, monitors high-quality practices during all phases of the product life cycle, and ensure precise completion of all quality-related operations. This improves overall quality of the finished product.
Due to this reason, QMS is slowly becoming an important part of various manufacturing organizations, particularly pharmaceuticals.
Because in pharma manufacturing, even a small deviation from the required standards can impact the health and lives of people consuming its. And ensuring quality standards through spreadsheets/manual methods isn’t reliable and effective. This makes a QMS Software imperative for pharma companies for production of safe and quality drugs.
Modules of a Quality Management System!
A QMS software for pharmaceutical industry consists of various functionalities that offer multiple benefits to the companies.Before having a clearer picture of its benefits, let’s have a look at its different modules.
Various robust modules together form a pharmaceutical quality management software-
- Document Management Module
- Complaint Management Module
- Audit Management Module
- Non-Conformance Module
- Corrective Action & Preventive Action (CAPA) Module
- Training Management Module
- Standard Operating Procedures (SOP) Module
- Risk Management Module
- Change Management Module
Key Benefits of a Quality Management System!
Ensures Compliance with Regulatory Standards
Ensuring compliance with regulatory standards is crucial within the pharmaceutical industry. To simplify this process, a robust QMS solution is essential. It helps establish policies to ensure that procedures and products meet all regulatory requirements set forth by organizations such as the FDA, EMA, and others.
Furthermore, a QMS also assists pharmaceutical companies in adhering to the cGMP guidelines and 21 CFR Part 11 regulation, with the latter focusing specifically on electronic records, signatures, and other pertinent regulatory requirements.
With it, manufacturers can guarantee the genuineness, integrity, and dependability of electronic records and signatures used across different facets of drug manufacturing, testing, and documentation. This proactive approach not only safeguards product integrity but also reinforces customer confidence.
Enhances Product Quality & Safety
Long term success of every company highly depends on customer satisfaction. In a company, quality of the products and services together fulfill this requirement of making customers satisfied and happy.
To simplify this process, a QMS is needed. As itresponsibly monitors all the operations taking place across the supply chain and helps manufacturers ensure quality and safety of the medicines.
Moreover, by implementing quality checks, a Pharma QMS Software ensures that the raw materials, manufacturing processes, and finished products are meeting the required standards without deviations. This helps companies maintain product quality and reduce the possibility of recalls.
Improves Efficiency & Reduces Costs
In the process manufacturing industry efficiency is un-compromisable to earn profits. Especially inthe pharma industry, where time-to-market is crucial. A well-designed QMS optimizes workflows and eliminates the need of reworks.
It helps organizations achieve greater consistency in the processes, reducing waste and thus minimizing costs too. This promotes proper use of time and resources. And so, the overall operational efficiency of the organization is increased.
Performs Risk Management & Mitigation
Pharmaceutical manufacturing involves various inherent risks, ranging from contamination to non-conformities. To help an organization in this, a QMS offers a systematic approach to risk management through its methodologies and preventive measures.
It helps manufacturers identify, analyse, and remove all the potential risks that are present throughout the supply chain. This type of pro-active approach minimizes the likelihood of adverse events and their impact on product quality.
Improves Internal Communication
QMS provides a supportive environment that promotes collaboration and knowledge sharing across different departments. Because of this, employee experience improved coordination and become capable of delivering prompt response.
Also, with a centralized platform, a QMS system ensures that all the business crucial information is readily available to users. This provides a single source of truth and eliminates the need of manual data sharing.
Lessens the Risk of Errors
Standardization helps eliminate confusion and variations that lead to mistakes. A Pharma QMS Software establishes a standardized framework for all the processes such as product development, manufacturing, quality control, etc. This helps employees follow the best practices, ensuring consistency and reducing the likelihood of errors.
These benefits clearly portray the importance of Quality Management System in the Pharma manufacturing industry. But it’s also necessary to choose the most efficient one out of all.
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