Quality Management System Software
Details Atachi QMS has an in built intelligence to capture documents processes, procedures, and responsibilities for achieving quality policies with strict adherence to GMP (Good Manufacturing Practices) and objectives of an organization. Atachi QMS (Quality Management System) for Pharmaceutical Manufacturing has built on the International Conference on Harmonization guidelines ICH Q10, cGMP (common Good Manufacturing Practices) and FDA 21 CFR Part 11 guidelines. At Atachi, we have built the QMS has strict adherence to the the ICH Q7 guidelines for API (Active Pharmaceutical Ingredient) Manufacturers. Our QMS is implemented and/have most of in-built controls for the Quality Risk Management as per the guidelines of ICH Q9 is properly managed at every step of the manufacturing processes along with facilities, equipment, environment and personnel.
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Sampling Plans
Deviations
Atachi Quality Management System (QMS) regulates quality, deviations from the stipulated quality parameters and other quality related issues.
Atachi QMS has the ability to integrate and monitor the process deviations, environmental parameters, operational deviations and equipment deviations to take immediate intelligent action(s).
Operator Training and Certifications Your organization can introduce enforcement of certification for process steps through Atachi QMS by separating roles with different certifications.
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Change Management Atachi QMS has the ability to manage the change management by providing the controls like change, review, approval, execute
NCR and Alerts Creation of Non-conformance report during the deviation with in the set limits, automatic notifications by SMS/email to applicable personnel for immediate action is part and parcel of Atachi QMS.
Regulations/ Compliance Atachi QMS implementation affects every aspect of an organization’s performance. It helps in meeting the customer requirements which instill confidence in the organization which turns into leading to more customers, more sales and more repeat business.
Atachi Systems offers a comprehensive suite of quality management System software for companies of all sizes. Our software ensures compliance with requirements.