Under Parts 210-211, acceptance or rejection of a product rests, to a large extent, on the product's adherence to specifications. For example, testing for conformity to written specifications is required for every component of the product (Sec. 211.84). In the same vein, finished drug products that fail to meet established standards, specifications, or other relevant quality control criteria will be rejected (Sec. 211.165). Where there's an out-of-specification test result, an investigation must be conducted and its results documented (Sec.211.192).
In addition, the FDA has issued a guidance called Investigating Out-of-Specification Test Results for Pharmaceutical Production, which reinforces the importance of appropriate handling of OOS. The guidance applies to chemistry-based laboratory testing performed on active pharmaceutical ingredients (API), excipients and other components, in-process materials, and finished drug products. MasterControl offers out of the specification (OOS) software to manage the pharmaceutical production according to FDA compliance.
Similarly, medical device companies must establish a procedure with the help of OOS software for ensuring that every device conforms to its specifications (Sec. 820.70). Any out-of-specification incident must be investigated, documented, and resolved. As in other issues that significantly affect product quality, OOS cases may be escalated to the corrective/preventive action process.
MasterControl OOS Software for Automating Out of Specification (OOS) Processes
Many of our FDA-regulated customers rely on MasterControl Forms™ to automate the process of collecting and controlling data critical to compliance. MasterControl Forms offers the flexibility in terms of design, routing, and user and security roles. The OOS software provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Data captured on forms is automatically entered in an SQL database, and can be used for analysis.
MasterControl Forms' robust features make out of specification software an ideal solution for managing Out of Specification OOS processes.
Here's how MasterControl Forms addresses some of the major challenges that companies face in establishing and maintaining forms-based processes.
|Forms Automation Challenges||MasterControl Forms™ Software Solution|
Inefficient Paper Forms System
A paper-based forms process can be plagued with inefficiency and such issues as: filling out the wrong form, not completing the right form, and sending the form to the wrong person.
| Cost-Effective eAutomation System |
MasterControl OOS sofware automates any forms-based process and offers best-practice features that prompt users with selected data. It automates routing, notification, escalation, and approval for faster turnaround. MasterControl is Web-based, so employees, customers, and suppliers can participate in forms-based processes (i.e., data input and verification) from virtually anywhere.
|Poor Data Capture |
Forms in out of specification software are designed to gather accurate and complete information critical in compliance. With paper forms, the onus lies with the operator to input accurate and complete information, and then for an analyst to accurately transfer this information to a spreadsheet or other analysis tool.
| Accurate Data Capture |
In creating new forms or improving existing ones in the OOS software, companies can use a variety of field formats for accurate and accelerated data collection. With a click of a mouse, a user can select common responses keyed in the form fields that allow a list of data options previously entered. This helps ensure data is entered correctly into the form. Fields can also be set up to calculate data using simple or complex math operations.
| Disconnected Processes|
Manual systems don't connect forms-based processes (audit findings, corrective action, etc.), making continuous improvement almost impossible. For example, without an OOS software, if the customer complaint process is not linked to the corrective action process, a critical complaint may languish indefinitely before it can be acted upon and remediation is initiated.
MasterControl's out of specification software integrates different quality processes for a more effective and efficient quality management. For example, a change submission form can be launched directly from a CAPA form, connecting one process to the next. Relevant information will be automatically entered into the new form, reducing data entry and avoiding mistakes common in manual transfer of information.
Out of Specification Software Features
Here are some of MasterControl Forms' powerful features:
Efficient Forms: MasterControl's OOS software automates any forms-based process, including routing, notification, escalation, and approval.
- Routes can be created based on a company's unique needs. For example, forms can be routed for data entry/data collection and approval. MasterControl incorporates escalation of overdue tasks. System administrators can easily create a variety of individually tailored user and security roles within the OOS software.
- MasterControl Forms is Web-based so employees, customers, vendors, and others involved in forms-based processes can perform their tasks from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of forms by all authorized users.
- MasterControl tracks forms by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
- Completed forms are indexed and stored, so users can search on the contents of the form.
- Forms can be signed and approved electronically. Signature manifestation, name, date, time, and meaning of electronic signature can be appended automatically to each document. MasterControl's electronic signature features in OOS software comply with the FDA's 21 CFR Part 11 requirements.
Flexible Form Design: Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so end users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.
Offline Forms : Off-site and traveling users or external parties (customers, vendors) can complete forms and stay in the loop even without being connected to the MasterControl out of specification software. They can complete forms offline and then upload.
Form-to-Form Launching : A form can be launched directly from another form, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered that process.
Document Approval via Forms : Some forms-based processes are so tightly connected with the document approval process, requiring the same signatures for both. With this feature of OOS software, the process is streamlined. A form and the documents linked to it can be approved all at once, avoiding repetitive steps.
Conditional Routing: Quality-related tasks can be routed to different users depending on data entered into the form. For example, a complaint can be routed to the appropriate product team by selecting the product from a drop-down field.
Supervisor Route: Many forms-based processes require approval by a supervisor no matter who initiates the process. With MasterControl's out of specification software, you can add the "supervisor" to forms routes. It can also be added in succession, so the route will move from a supervisor to that person's supervisor, and so on, along the hierarchy.
Analytics and Reporting: Data captured on forms is automatically entered in a SQL database. Companies can use built-in tools of the OOS software to filter the data, and then chart results for instant analysis. MasterControl's advanced analytics and reporting capability provides standard and customized reports to help increase management oversight.
To Learn More on OOS Software
For more information about out of specification software, please feel free to contact a MasterControl representative.