Life sciences quality management software
Our life sciences quality management software, Q-Pulse, has been expertly tailored to the specific challenges of the life sciences industry. It automates and streamlines processes to ensure excellence in quality, safety and compliance.
Transforming quality and compliance for life science
With state-of-the-art functionalities, Q-Pulse delivers frictionless collaboration and robust security, wherever your teams are in the world. Painstakingly designed with users' needs in mind, it brings simplicity and ease to compliance.
Identify and minimise issues
Understand where quality and compliance issues usually arise and take action to minimise disruption.
Strengthen brand name and reputation
Enhance reputation with customers, regulators, and certification bodies by providing evidence that correct actions have been taken and correct procedures followed.
Drive accountability throughout your organisation
Ensure employee accountability for actions that contribute to the effective and safe production of high-quality medical devices and products
Ensure continuity of compliance
Fully validated SaaS solution with dedicated validation support services to ensure ongoing maintained compliance.
Transform operational processes
Increase efficiency of processes to substantially decrease the time spent on compliance activities.
Ensure data integrity
Implement a risk-based quality management system that drives constant improvement in product and process reliability.
Q-Pulse: Life Sciences Edition
Serving life science clients across the world, we're the experts in technology for regulatory compliance (RegTech). Whatever your niche, and whatever the regulation, we're committed to helping you meet - and prove - your compliance with the least stress possible.
Our existing clients have employed Q-Pulse to demonstrate compliance with a number of international standards and regulations, including:
- ISO
- The FDA (including 21 CFR Part 11)
- The US Department of Agriculture (USDA)
- MHRA
PleaseReview
PleaseReview is an innovative solution for collaborative document review, co-authoring and redaction.
Used widely by Medical Writing, Regulatory, Clinical, Quality and other professionals within the Life Sciences sector, it seamlessly upgrades the review of reports, submissions and publications.
Its next-generation redaction capabilities also enable companies to comply easily with EMA Policy 70 requirements.
Life science software validation
Offered by our partner, CompliancePath provides validation for our Q-Pulse and PleaseReview products, alongside validation for any other life sciences software.
Incident Management Software
A central focal point for the effective capture of information minimises the risk of data inaccuracy and avoids data duplication. Our Q-Pulse Mandatory Reporting System (MRS) takes CAPA and risk management to the next level by allowing you to conduct a risk assessment against any incident and then help to mitigate that risk by putting control measures in place.
Our laboratory compliance software is trusted across many life sciences sectors
Blood and Biologics
Organisations worldwide use our QMS software to help ensure the collection, testing, processing, storage and distribution of blood is performed in a robust, quality-assured environment.
Biotechnology
Our biotech QMS solutions can help your company cost-effectively achieve and maintain compliance with the latest industry norms.
Medical Devices
Our medical device QMS software solutions support key business processes, ensuring quality, reliability and safety are achieved throughout a product’s lifecycle.
Pharmaceutical
Our pharmaceutical quality management software solutions support both the review process and the management of critical documents.
Customer spotlight on Spire healthcare
Learn about Spire Healthcare’s experience with using our Q-Pulse product to manage quality and support their processes in order to meet ISO 15189, connecting their 22 different laboratories to work to the same standards.
Watch case studyCovid resources for life sciences
We look at the impact of Covid-19 on the industry and what the future holds in terms of innovation and collaborative practices.
