Life Science Regulatory Compliance Software
Life Science companies must demonstrate high levels of quality and compliance with a number of international standards and regulations such as ISO, the FDA (including 21 CFR Part 11), US Department of Agriculture (USDA) and MHRA.
Complying with these standards requires an effective regulatory compliance software solution to help manage all the compliance needs across the entire organisation.
Ideagen's Regulatory Compliance software, Q-Pulse, helps Life Science organisations across the world successfully meet and maintain their regulatory requirements. Ideagen's solutions and services will help to increase efficiency and productivity, reduce costs and gain valuable insight into how the compliance processes that take place across the organisation could be improved.
More than 200 Life Science organisations worldwide including Reckitt Benckiser, Reading Scientific Services (RSSL) and Roslin Cells, rely on Ideagen to help them improve the management of their compliance processes and information, increase overall business efficiency, and transform the management of these compliance activities from a costly overhead into a business benefit.
Compliance, Efficiency, Safety and Productivity
Bodies such as the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) are committed to ensuring quality and best practice is maintained to a high level. For life science organisations, this demands commitment to ensuring products and services are delivered in a robust, quality-assured environment.
- Audits must be carried out to ensure these procedures followed, staff can easily report problems.
- Assets must calibrated and maintained with an audit trail.
- Suppliers must be audited to ensure their products and services are of the necessary standard.
- Staff must be shown to be competent.
Q-Pulse, from Ideagen, is a fully integrated Electronic Quality Management Solution (eQMS) that helps businesses transform their operational processes and substantially decrease the time spent on compliance activities.
Ensure Data Integrity
"Good science is based on reliable observation and the data can only be relied upon if scientists are open and honest. People in the UK generally trust science because they know that experimentation is the most reliable route to knowledge. Anything that could be seen to jeopardise both the process and the trust it engenders is dangerous and needs to be rooted out."
— Sir Paul Nurse, President of the Royal Society
Data integrity is a high profile issue in the Life Sciences industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by FDA, MHRA and other European regulatory authorities.
Data integrity issues affect pharmaceutical companies everywhere. The majority of cases are caused by inefficient and fragmented business processes rather than deliberate fraud, most are captured by internal inspection and audit processes within the business and, therefore, remain buried and never come to light. However, to protect themselves from exposure to the risk of non-compliance with data integrity norms and laws such as the Food and Drug Administration Safety and Innovation Act (FDASIA), Drug Quality and Security Act (DQSA) and EU GMP, organisations must implement a risk based quality management system that drives constant improvement in product and process reliability. Helping them;
- Modernise operational processes
- Improve the overall performance of your organisation
- Prevent failures and damage
- Protect your corporate, professional and personal reputation.
Check out our 'White Paper, A Nudge in the Right Direction', which discusses a systematic approach to compliance management in the laboratory.
ISO 13485 Compliance
ISO 13485 is a globally recognised medical device standard and specifies requirements for a quality management system in order to ensure and verify that customer and regulatory conditions are met by the medical device industry.
Compliance with ISO 13485 can enable medical device companies to implement and streamline robust processes and procedures to ensure quality, reliability and safety are achieved throughout the product lifecycle. Within a shifting global market, consistently delivering high quality products or services can create competitive advantage for medical device companies. A robust product lifecycle that follows the principles of ISO 13485 can accelerate time to market and mitigate future risk for organisations.
Download the flyer to discover how Q-Pulse can help accelerate time to market for medical device organisations
Comply with ISO 9001: 2015
"There has been some debate internationally about the implications of the proposed changes for both quality and audit professionals. Some national bodies regard the changes as insignificant, taking the view that ISO 9001:2015 simply introduces a number of requirements that were previously implied in ISO 9001:2008 but that were not mandated."
"The CQI and IRCA do not share this position. We remain convinced that those leading, managing and auditing quality management systems will need to revise their current thinking and work in different ways in order to maintain organisational compliance."
— DIS 9001 2014, Understanding the Draft International Standard, IRCA and CQI
Read our white paper that explains how our software products and solutions can help you prepare for and comply with ISO 9001:2015.
Risk, Leadership, Communication and Processes
The world’s most popular standard – ISO 9001 – is changing: a substantially updated and revised version will be published in 2015 to replace the 2008 edition. Ideagen works closely with compliance and risk industry analysts around the world and the most frequently asked questions they receive relate to the imminent changes in ISO 9001 are:
- How do I extend my quality management system out to third parties in my supply chain?
- In practice, how do we implement a risk-based model of quality management?
- Where should we start?
Our White Paper responds to these questions: you want to know what the changes in the standard mean for your organisation, and you specifically want to understand how our products have evolved to help you prepare for and align with ISO 9001: 2015.
Read our white paper which explains how our software products and solutions can help you prepare for and comply with ISO 9001:2015.