The GMP challenge

Good Manufacturing Practice means having robust systems, processes fit for purpose and reducing product variation.

To do this, you need tools which provide visibility, control and accountability.

Our software is used by global life science, food and beverage and other heavily regulated businesses to implement best practice management systems. Our customers have:

  • Control and confidence in their approach
  • Improved collaboration from shop floor to top floor
  • Validated configurations of our software to meet the most challenging regulations

 

GRC software governance risk and compliance

Manufacturers using our software

Biotech quality management software
pharmaceutical quality management software
pharmaceutical qms software
asn agriculture quality
premier nutrition agriculture quality system
berryworld soft fruit
York instruments medical devices quality management software solution
Woven textile manufacturer W E Rawson Ltd integrated Management system
Elementis chemicals quality management software system
Roberts mart manufacturing ISO 9001
UK power reserve quality management system
Medical device manufacturers ISO 13485 DYSIS
Monosol quality management system ISO 9001
Sodexo ISO 55000 software
Unilever quality management outsourcing
Diageo beverage document control packaging management
Aerospace manufacturers quality management software
A B Agri food and quality management software

All modules work on their own or together

Audit management software
Audit management software
Too many businesses hope that when an external auditor is examining their business they don’t uncover any issues. But this approach causes stress, encourages a reactive culture and exposes the business to high levels of risk. A regular and thorough internal auditing programme helps you identify an...
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Equipment maintenance software
Equipment maintenance software
Over 70% of organisations have no formal method for managing how equipment is used, maintained and eventually replaced, or for ensuring there’s a qualified person on-site to operate that equipment. Managing business equipment correctly is crucial if your organisation is to compete in the fast-pace...
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Accident & incident management software
Accident & incident management software
When an accident or incident occurs, it's important there is an accurate record of events to understand the root cause and prevent it from happening again. Use our accident and incident management software to properly record, communicate and identify trends to prevent it from happening again.
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Document control software
Document control software
Modern technology means we are bombarded with information. The challenge is making sure the right information is viewed by the right person at the right time. Document Manager by Qualsys provides a comprehensive and powerful solution for the distribution and control of all types of crucial documenta...
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Supplier management software
Supplier management software
Qualsys's supplier compliance management software provides you with all the controls you need to treat external providers as an extension of your business. Deliver unshakeable governance, risk and compliance controls, understand supply chain risks, and extend quality best practice to your suppliers....
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Mobile document navigator application
Mobile document navigator application
Your employees want to use the right information, not fight with duplicate forms, outdated spreadsheets and cluttered inboxes. Our document navigation application shows the right information to the right person, wherever they are.
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See our GMP software system in action. Request a demonstration here:

Related articles

Life science
You need to prove your products are safe to use and will deliver the intended results. Our software provides you with a best-practice framework and all the evidence you need to keep control of your processes and demonstrate consistency.
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Food and drink
When it comes to sourcing, processing and packaging food, variation is dangerous. Our food safety and compliance management software helps you plan, manage and demonstrate that you've followed the correct processes, policies and procedures.
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FDA
Use Qualsys's software to get control, visibility and confidence that your business complies with the FDA (Food and Drug Administration).
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Medical device
Protecting your patients and getting your medical devices to market starts with a strong quality and compliance management system. Our software and services guide you through the entire process, ensuring you have a best-practice system which meets the most rigorous compliance requirements.
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ISO 13485
With increasing regulatory pressure to implement robust design controls, supplier accountability and risk-based thinking, many companies in the medical device industry opt to follow ISO 13485:2016 for a best practice framework. The Standard harmonises global medical device regulations, helping compa...
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Validation
Global pharmaceutical businesses, NHS trusts and other life-science businesses have been able to validate our software as compliant with the requirements of regulations such as GAMP 5, ISO 9001, ICH GCP E6 and FDA 21CFR Part 11, and electronic signature legislation such as the EU Electronic Signatur...
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ISO 14971
ISO 14971 defines international requirements for risk management systems for medical devices. Our software helps you to implement best practices throughout the entire lifecycle of your medical device.
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ISO 13485 software validation process
When you're implementing an electronic medical device quality management system, your software validation plan is of the utmost importance. You'll need to ensure that your system is working and continues to work as required.
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