Pharmaceutical Quality Management System Solutions
Ideagen's electronic pharmaceutical quality management system (QMS) reduce the time, effort and cost spent on achieving and maintaining regulatory compliance.
Working within aseptic services, dispensing, medicine information, or any other area within pharmacy, key compliance processes and procedures such as managing documentation and standard operating procedures and eﬀective audit and CAPA management, are all essential in order to meet strict regulatory guidelines and standards.
The historic management approach of fragmented systems, paper and manual processes, electronic documents, spreadsheets and email is inadequate and creates a crippling bureaucratic burden. Our pharmaceutical quality management system solution can help resolve these issues.
- Documented, accessible and controlled Standard Operating Procedures (SOPs)
- Schedule of internal audits
- Issue and non-conformance reporting and management
- Staff competence management
Feeling Overwhelmed By Your Validation Requirements?
We have the toolkit and knowledge to make it easy for you
- Align your validation plan to your conﬁgured Q-Pulse system
- Customise validation content into documents which suit your internal processes and requirements
- Make an informed decision on the level of validation testing your organisation needs to perform
- Significant reduction of the time, eﬀort and cost of your validation activities
- Maintain your validation status against any future system changes
- Develop a validation plan speciﬁc to your organisation to achieve compliance with your key regulatory requirements, including the FDA 21 CFR Part 11 and Part 820; and EudraLex Volume 4, Annex 11
"Q-Pulse basically speeds up the process of document control, making our departmental information easily accessible, helping us to comply with regulatory requirements, and manage compliance in accordance with GMP guidelines."
— David Sproates, Lead Pharmacist of Oncology and Aseptic Services at Gateshead Health NHS Foundation Trust