Validation Deviation Summary Report
Qualer CFR 21 Part 11 Validation Service Document
Qualer Validation Deviation Summary Report
The Deviation Summary Report (DSR) documents any test steps from the IOQ that do not match the expected results, or it indicates that no deviations occurred during validation. The report outlines the root cause of the deviation and lays out the steps required to address and close each deviation.
Qualer maintains 21 CFR Part 11 Validation according to the written standard established by the International Society of Pharmaceutical Engineers (ISPE) GAMP 5. Our validation service is executed in accordance with GxP standards producing a validation library that features signed electronic documents.
Accurate Asset Measurements
Qualer Validation and Compliance Plan – 21 CFR Part 11 Validation
Qualer’s Compliance Management Software ensures total compliance and audit readiness by managing all of your assets on one, easy-to-use dashboard. With the ability to view the current status of your assets and upcoming deadlines across your entire organization, you can easily take action on upcoming items to remain in a state of control. This allows Qualer’s software to easily track if a deviation has occurred through the validation process.
Qualer’s cloud based compliance software solution provides real time, on the go access, underneath one digital dashboard.
Qualer provides cloud-based validation compliance software. Qualer’s Compliance Management Software offers real-time, on-the-go access to every part of a business. Technicians can access your system at any time and location, even without internet access. See what’s happening in every area of your business in real-time, on one digital dashboard. Now your company will be able to view job statuses, new work orders, tech information, asset profiles, and specifications under one system.
Qualer CFR 21 Part 11 Validation Service
Qualer has created a CFR 21 Part 11 validation service, to validate the system in accordance with GMP standards. Get More Details