The cGMP 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

 

Complex circle

EQMS is designed to improve product quality and data integrity

Get to market faster, complete confidence in audits, prevent recalls

Electronic signatures

FDA CFR 21 part 11 and EU annex 11 compliant electronic signatures provide you with peace of mind & defensible records.

Manage competency

Identify competency gaps and opportunities of your stakeholders, document training records and holistically improve business performance.

Intelligent workflows

Use parallel or sequential workflows to keep your stakeholders informed and drive action where necessary. Eliminate bottlenecks and focus on improvement.

Version control

Complete control over SOPs, policies and any other type of document.

Audit trail for everything

There is an audit trail for everything in EQMS. See who changed what, when, why, where and how.

Manage change

Identify, assess and treat risk as your business adapts, evolves and iterates products and services.

Advanced reporting

An interactive business intelligence dashboard enables you to track and measure a balanced scorecard of metrics.

Apply your quality methodology

From 5 Whys to 8D, apply your quality methodologies to the workflows in EQMS to embed continuous improvement.

Manage audits

Streamline the planning, management and reporting of audits and inspections.

Why cGMP-regulated businesses partner with Qualsys

Compliance-as-a-Service

We don’t simply provide you with our software and say “off you go!”. Qualsys provide support services at every stage in your journey:

  • URS templates
  • Validation test scripts
  • Scoping workshops
  • Product training
  • Ongoing support
  • System health checks
  • Audit, SOP, issue & workflow templates and example
  • War room audits
  • Optional quarterly configuration reviews

Read our implementation brochure

Business Intelligence dashboard by Qualsys

Tailored GAMP 5 validation

You will have a dedicated computer systems validation expert who will guide you through each step of implementing and maintaining your eQMS.

Our team have validated more than 500 systems using both IQ/ OQ/ PQ and GAMP 5 methodologies and helped hundreds of organisations to pass regulatory and ISO audits in complete confidence.

Here Liam explains our validation approach

Flexible API / ERP integration

Connect your existing tools and systems with EQMS to avoid manual data input issues and drive automatic activity.

Flexible API / ERP integrations can be as simple or complex as your requirements. Qualsys provides a complete service to ensure your integrations align with your data integrity and product quality requirements.

More on our API / ERP integrations

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.
Read more

See our GMP software system in action. Request a demonstration here:

Related articles on our blog:

IQ OQ PQ or GAMP 5 for validating EQMS?
At the Qualsys Quality in Life Science event, Liam Pollard, Service Implementation Manager, explained why he prefers the GAMP 5 approach to computerised system validation to the traditional IQ / OQ / PQ approach, the benefits of GAMP 5 and some tips to help you on your journey when implementing EQMS...
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Data integrity for pharmaceutical computerised systems (GAMP 5)
To stay competitive, reduce overheads and scale the business, most manufacturers rely on an advanced and integrated portfolio of automation tools. When the manufactured products have a clinical, pharmaceutical or medical device use, the manufacturer must be able to demonstrate that the software is f...
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Computer system validation: The Qualsys approach
Computer systems that are used to support regulated processes in the pharmaceutical, healthcare and biological industry need to comply with the expectations of the regulatory authorities. One of the most crucial requirements is computer system validation. This is the umbrella term for ensuring all ...
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