Out of Specification (OOS) Software
Good Manufacturing Practice (GMP) regulations require pharmaceutical, medical device and other regulated manufacturers to conform to approved specifications that define the parameters for a product to be considered safe. Many companies rely on out of specification software to help them investigate and resolve OOS incidents.
Kostenlose Ressourcen
Wählen Sie alle Ressourcen aus, die Sie herunterladen möchten
MasterControl Out of Specification (OOS) Software Solution
MasterControl automates the process of identification, assessment, investigation and disposition of out of specification incidents. MasterControl’s OOS management solution connects critical quality processes, so if an OOS incident warrants a corrective action and preventive action (CAPA), the escalation would be seamless.
OOS Management Challenges |
MasterControl OOS Solutions |
|
Prone to Errors Manual data entry is prone to errors. It is easy to forget to include certain information or input the wrong data. |
Reduced Data Entry Automation of data collection reduces manual data entry and minimizes user errors. |
|
Inefficient It takes longer for users to manually enter data and make sure the information is complete. Distribution and processing of paper forms also require more time and effort. |
Efficient MasterControl automates the OOS management process and offers best-practice forms that prompt users with selected data, greatly increasing efficiency. |
|
Lack of Connectivity A paper-based OOS management process is not connected to customer complaints, CAPA and other quality processes. Without the necessary connectivity, it’s harder to see if an OOS incident correlates with other quality events. |
Connected Processes MasterControl’s integrated platform connects the OOS process with other quality processes for a holistic compliance effort. A user can initiate a CAPA from the OOS process if the incident warrants a CAPA. |
What is OOS?
An out of specification, or OOS, refers to a material, component, product or laboratory test result that falls outside approved acceptance criteria. A specification consists of a numerical range or limit that defines what’s acceptable for a material or product to be considered safe according to its intended use.
Benefits of MasterControl’s Out of Specification Software
- Best-Practice Forms The solution’s best-practice forms make it easier for users to participate in the investigation and resolution of OOS incidents
- Integration With Other Systems For companies that use ERP or other electronic systems, MasterControl can be integrated with other applications without the need for expensive custom coding.
- Powerful Analytics MasterControl’s robust reporting capability allows users to utilize their data in meaningful ways for insights into trends and patterns.
- Automated OOS System MasterControl’s out of specification software solution automates and streamlines workflows for increased efficiency and productivity.
How to Leverage OOS Data
OOS in pharmaceutical, medical device and other regulated products or their components typically leads to rejection of the material in question. Under GMP regulations, the quality unit is responsible for OOS quality control and for approving or rejecting components or products. Users can leverage OOS data with the proper analysis and use the information to improve testing and stability studies.
QMS-Anbieter für die FDA
MasterControl Inc. und sein Partnerunternehmen i4DM erweitern ihr FDA-Projekt und wollen als QMS-Anbieter für einen zweiten FDA-Bereich fungieren. Die beiden Unternehmen sind seit 2009 als QMS-Anbieter für das Office of Regulatory Affairs der FDA tätig und möchten nun auch als Qualitätsanbieter für die Division of Pharmaceutical Analysis fungieren, die Teil des Center for Drug Evaluation and Research der FDA ist.
Weitere Informationen zu MasterControl!
Um weitere Informationen zu MasterControl zu erhalten, wenden Sie sich an einen MasterControl-Mitarbeiter.
