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Quality Management in Life Sciences: Mitigate Risk and Drive Growth

 

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Pharmaceutical and drug companies, biotechnology firms, medical device manufacturers, businesses in the genetics and genomics sector, and other life sciences organizations all produce products with rigorous quality requirements.

Ultimately, their success (and oftentimes, the health of patients) relies on the ability to produce a quality product.

To effectively manage the content, processes, and other nuances involved in producing and delivering products in a quality-centric environment, life sciences firms utilize a Quality Management System (QMS)

 

Who Should Use a QMS?

QMS platforms are most often leveraged by companies that operate in highly regulated industries to ensure that quality processes are adhered to and to help them meet regulatory compliance requirements. A QMS gives an organization a set of tools to control their quality processes, which can range from document publishing and employee training to managing audits and tracking the resolution of issues and risks.

By maintaining a detailed audit trail of all document activity, securely tracking activity by individual, and providing support for electronic signatures, life sciences companies can leverage a QMS to ensure compliance with industry regulations and standards, such as: 

  • FDA 21 CFR Part 11
  • ISO 9000, ISO 9001, and other manufacturing standards
  • Health Insurance Portability and Accountability Act (HIPAA)

If you would like to learn more about ISO 9001 — and how a cloud QMS can get you certified — click here. If you're interested in learning more about HIPAA, click here


What to Look for in a Quality Management System

Life sciences companies that produce products with rigorous quality requirements face numerous challenges, and one nearly universal challenge is the need to maintain strict control over documentation. This can range from marketing brochures and training documents to Standard Operating Procedures (SOPs) and material datasheets. 

Not only must document versions be meticulously tracked and managed, but the appropriate set of individuals must be notified when new drafts are published — and access controls must be strictly enforced during the entire process.

A modern QMS should intelligently connect with existing systems and make it easy for your employees to manage quality-related content and processes without having to change how they already work. Look for platforms that can address a broad range of quality- and compliance-focused requirements, such as:

  • Reducing production errors. Lost and outdated versions of design, manufacturing, and support documents can quickly lead to quality deviations and nonconforming products.
  • Proof of adequate training. Companies are often required to prove that stringent measures are taken to minimize risks, including documenting training content and employee participation.
  • Streamlining audits. Firms must provide evidence to auditors that prove the company is following defined processes. A QMS can collect evidence of recurring tasks that proactively remind employees to take action on these assignments.

For more guidance about what to look for in a QMS, check out our Top Three Tips for Evaluating a Cloud Quality Management System.

 

AODocs: A Modern Approach to QMS

Many life sciences companies find it challenging to effectively manage the massive amount of information that resides in a variety of systems throughout their enterprise.

However, modern quality management systems are enabling these organizations to better optimize their critical operational information by ensuring the right content and data are in the hands of the right people at the right time. 

AODocs for Life Sciences is a secure and sophisticated Quality Management Solution (QMS) that helps life science companies address FDA and GxP compliance, accelerate internal innovation, keep business-critical data secure, and deliver products to market faster.

With AODocs’ cloud-based QMS, life sciences firms can comply with GxP, ISO standards, and FDA Title 21 CFR Part 11 while providing users with an intuitive and human-friendly quality management system.

Want to learn more? Watch the Introducing AODocs for Life Sciences webinar and check out our What is GxP? blog post.

 

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