Document Control Software: Q-Pulse for Life Sciences

Blood Services

As a Blood Bank or a supplier of Blood Services, your organisation is required to ensure that the collection, testing, processing, storage and distribution of blood are performed in a robust quality-assured environment. From FDA and AABB regulations to MHRA Blood Safety and Quality Regulations, organizations all over the world have embraced the principles of Quality Management in demonstrating their regulatory compliance status.

The complexity of this situation is increased by the fact that regulatory compliance systems have to often sit either alongside or within existing accreditation frameworks such as CPA or CAP without any additional overhead or resource to manage these interactions.

With the penalties for failing to comply with laws and regulations also increasing, managing compliance with legal and regulatory requirements is increasingly important in reducing time and effort, reducing the duplication of effort and reducing resource expenditure.

Q-Pulse is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments including ISO 9001, GxP and ISO 13485.

Together with Q-Pulse's technical controls, our range of professional services, including supporting documentation and training, provide procedural controls that can help you to put the administrative controls in place for a complete 21 CFR Part 11 solution.

See Blood Bank Case Study:MountainStar and New England Organ Bank Case Study