Just because I have a fitness app on my phone doesn’t make me an athlete.- Dr. Harry Greenspun – Senior Advisor, Healthcare Transformation and Technology at Deloitte
Q-Pulse is a fully integrated Electronic Quality Management Solution (eQMS) that will help laboratories significantly decrease the time spent on day-to-day compliance activities.
These activities include document management, auditing, corrective and preventive actions (CA/PA) management, asset (hard and soft) management, and supplier/vendor information and non-conformances. Recognizing the importance of managing training and proficiency testing; Q-Pulse does so through a competency-based approach tied directly to job roles supported by training/education/experience requirements.
Furthermore, Q-Pulse IMS is capable of managing incident and safety reporting, including complete investigation and evaluation management as well as enabling data analysis.
Due to the nature of the Pathology sector, standards and regulators such as ISO 15189, the College of American Pathologists (CAP),Clinical Pathology Accreditation (CPA),Medicines and Healthcare Products Regulatory Agency (MHRA) and theFood and Drug Administration (FDA) are committed to ensuring quality and best practice is maintained to a high level.
As the requirement of regulatory bodies have increased, quality systems have often been viewed as a bureaucratic burden with little positive impact on a Pathology department.
Gael have developed solutions to help relieve these areas, and to change quality and risk management from a bureaucratic burden into an efficient benefit to the organization.
Many stem cell organizations find they are unable to manage quality and compliance effectively, and are unprepared when an internal or external audit is announced.
Using manual paper-based systems to manage compliance activities is often time consuming, impractical and labour intensive.
National and international quality standards and regulations including MHRA, FDA, HTA, HFEA, JACIE, ISO 9001 and GMP all require stem cell organizations to demonstrate compliance to their requirements. Many organizations across the stem cell sector use Q-Pulse to help them achieve and maintain regulatory compliance.
Blood Services organizations worldwide use Q-Pulse to help ensure the collection, testing, processing, storage and distribution of blood are performed in a robust quality-assured environment.
Achieving and maintaining compliance with the numerous regulations and standards within the Blood and Tissue sector such as the FDA’s21 CFR,AABB,CLIA-88, the EU Blood Directive, NetCord-FACT, ISO 15189 and ISO 17125, all require time and money. Strict quality and safety requirements demanded by these regulators means organizations must implement an effective system to integrate and centralize all their quality processes and procedures, to easily demonstrate compliance.
Organizations in the Pharmaceutical sector are required to comply with multiple standards and regulations – often with strict requirements and harsh penalties if these standards are not met.
Regulatory bodies demand that Standard Operating Procedures (SOPs) are maintained and easily accessed across the organization.
These SOPs include internal audits being frequently carried out and results documented, suppliers checked that they are delivering suitable products and services, assets regularly maintained and calibrated and that staff are competent in their daily tasks while areas of improvement have been identified and scheduled. As well as this, areas of potential risk are identified and registered – with the correct actions in place to reduce the potential of these areas of risk from occurring.
Regulatory bodies such as Medicines and Healthcare Products Regulatory Agency (MHRA), the US Department of Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Therapeutic Goods Administration (TGA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), demand that Standard Operating Procedures are maintained and easily accessed across the organization.
Working within Aseptic Services, Dispensing, Medicine Information, or other areas within pharmacy, key compliance processes and procedures are essential in order to meet strict regulatory guidelines and standards.
These processes and procedures include managing documentation and Standard Operating Procedures (SOPs) and effective Audit and CA/PA Management.
Q-Pulse was designed to help with quality and compliance management within Pharmacy by streamlining and managing all of your compliance activities. By using Q-Pulse, you can significantly decrease the time you spend on the non-productive areas of quality and compliance management – while also helping to reduce costs and increase productivity.
Regulations and compliance requirements for the cancer services sector have dramatically increased in recent years. Q-Pulse will significantly decrease the time required on day-to-day compliance activities.
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Multiple regulations, bodies and groups such as the Care Quality Commission (CQC),The Ionising Radiation (Medical Exposure) Regulations 2000,(IR(ME)R 2000), and the National Patient Safety Agency (NPSA), all specify a number of requirements be put in place to achieve regulatory compliance and sufficient quality standards.
Regulatory requirements include documented and easily accessible and controlled Standard Operating Procedures (SOP’s), frequent and scheduled internal audits, non-conformances and issues which can be easily logged, essential assets calibrated and maintained with full documented history and areas of risk that are able to be identified and acted upon before they occur. Staff are also required to be competent in carrying out their tasks through documented training schedules for each member of staff.
To help you overcome this, and effectively manage your quality system processes and procedures, Gael’s Q-Pulse is a fully integrated electronic Quality Management Solution (eQMS) that will help Cancer Service organizations significantly decrease the time spent on day-to-day compliance activities. These activities include document control, auditing, incidents and non conformance, suppliers, corrective and preventive actions (CA/PA) and staff training, increasing the time spent enhancing patient-focused services.
To learn more about Healthcare and Q-Pulse, visit Gael Quality