Pharmaceutical Regulatory Compliance
Organisations in the Pharmaceutical sector are required to comply with multiple standards and regulations - often with much stricter requirements and harsher penalties if these standards are not met. 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 Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), demand that Standard Operating Procedures are maintained and easily accessed across the organisation.
These 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.
Meeting all of these areas can be a problem - with Quality and Risk systems often becoming a bureaucratic burden of paper management with little integration between each of these manual systems. Gael have developed solutions that have been designed to be flexible enough to assist with regulation, compliance and risk management in a number of areas within the Pharmaceutical market sector including - Pharmaceutical Research and Development, Contract Research Organisations (CROs), Clinical Trials and Pharmaceutical Manufacturing.
To help ensure these organisations meet those strict compliance standards, Gael developed Q-Pulse allowing you to effectively manage compliance activities such as Document Control, CA/PA and Audit, in order to meet and maintain regulatory requirements.
Q-Pulse, from Gael Ltd, is a fully integrated eQMS that will help you successfully manage your Document Control, CA/PA, Auditing, Training, Suppliers, Customer/Client Concerns, Assets and Incidents in a single integrated solution. Helping you achieve regulatory compliance, Q-Pulse will significantly decrease the time and resources you spend on managing these key activities, whilst also helping to reduce costs and increase productivity.
In addition to Q-Pulse, Gael has developed Gael Risk to help pharmaceutical organisations to help identify and manage areas of risk, hazards, threats, consequences and controls. Gael Risk’s fully customisable dashboard allows you to have an overview of the total risk environment across the department. Plus, with full integration into Q-Pulse, your risk register can be automatically updated as incidents are logged in your Q-Pulse solution - likewise as incidents are closed, Gael Risk also changes accordingly.
Gael have a history in helping pharmaceutical organisations worldwide achieve and maintain regulatory compliance. Organisations such as Astra Zeneca, Reckitt Benckiser, Sanofi-Aventis and Reading Scientific Services Limited (RSSL), use Q-Pulse to help achieve regulatory compliance, improve the management of their compliance processes and information, and increase overall business efficiency. Adrian Kirk, Quality Manager at Reading Scientific Services Limited, said: "We chose Q-Pulse as we felt it would not only help us in meeting our regulatory compliance requirements, but would also enable us to free up staff time allowing us to focus on more value added activities. [Q-Pulse] enables us to have an overall greater control of our compliance activities as well as efficiency gains.”
Contact us now for more information on how Q-Pulse can help your organisation improve efficiency and cost effectiveness in managing your Quality and Risk systems.