Pharmaceutical Compliance Software Solutions

Ideagen's pharmaceutical compliance software solutions support both the review process and the management of critical documents. 80% of the top 25 pharmaceutical companies use our software to manage document review, along with hundreds of life science organisations worldwide who use our quality management software solution to meet international standards and regulations. These include ISO 13485, GxP, ISO 9001 and FDA 21 CFR Part 11.

Strengthen compliance and quality management with Q‑Pulse

Q-Pulse is used to help pharmaceutical companies achieve and maintain regulatory compliance. The pharmaceutical quality management system provides a centralised location to store all important documents with organisation-wide access, improving the management of compliance processes and the overall efficiency of the business. The QMS solution can be tailored to help companies build market reputation by adhering to standards. It also establishes trustworthiness as Q-Pulse reduces the risk of non-compliance through the CA/PA management function, with data being visible at a glance.

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Q-Pulse QMS software
PleaseReview document co-authoring and review software

Control collaboration with PleaseReview

Document collaboration is a critical process within pharmaceutical organisations. Our document review and co-authoring solution streamlines the process, significantly reducing the time spent on it and enabling a productive workflow for all parties involved in reviewing documents. The software cuts review times by 65% and the costs associated by 35%. It gives you control and visibility over a process that is typically difficult to track and monitor and an audit ready reconciliation report detailing all activity that took place during the document review.

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"We now have confidence we will be able to demonstrate compliance 'on demand' and be able to stand up to any regulatory or customer audit knowing that all procedures are reviewed, version controlled and that no actions will go unmissed."

Erik Paulsen, Quality Co-ordinator at Fresenius Kabi

Establish a full document control process

Together, PleaseReview and Q-Pulse enable organisations to manage the document control process with minimal effort. A non-conformance is raised through the CA/PA (corrective actions and preventative actions) module in Q-Pulse which may trigger the creation of a new document, or changes to be made to an existing one. Our pharmaceutical compliance software fully supports document control by reviewing and managing the changes within PleaseReview before uploading it to Q-Pulse for distribution and acknowledgement.

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