CRO Contract Organization Change Control Software Systems

Automate Paperless Change Control Processes for CxOs and to Ensure FDA GMP Compliance with (CRO) Contract Organization Change Control Software Systems

In the FDA and ISO environments, the concept of change control is closely interwoven with compliance. Contract research organizations (CROs) and other contract manufacturing organizations that help develop and manufacture medical devices are required under the Quality System Regulation ( 21 CFR Part 820) to establish control over design changes (820.30), document changes (820.40), and production and process changes (820.70). To cater this issue MasterControl introduced contract organization change control software systems for the pharmaceutical companies to fulfill the required under 21 CFR Parts 210-211 to control any change to established processes. Meaning the change has to be recorded, reviewed, and approved by the quality control unit.

MasterControl's CRO change control software is an integrated quality management suite which is configurable and easy-to-use software solution that helps CROs attain and sustain compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11 ) is a necessary component in FDA compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods and contract organization change control software to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

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How can CRO Change Control Systems Benefit You?

MasterControl's contract organization change control systems are designed to help contract organizations automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project. Here's how MasterControl can ease some of the major challenges in change control.

CRO Change Control Challenges		MasterControl Change Control™ Solutions
Disconnected Processes Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. In the context of CRO change control system, this could mean lack of follow-up, late notifications, and tasks not completed by deadline. Suppliers could be making changes without proper and timely notification.		Connected MasterControl's CRO change control software is an integrated solution that connects different departments with data and processes under a secure and centralized system. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks. MasterControl is Web-based, so even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere.
Poor Turn-Around Timeliness is essential in change control. A manual contract organization change control system that relies on paper-based documents to generate necessary data and old-fashioned legwork to route and track submissions and change orders is likely to have poor turn-around for change.		Excellent Turn-Around MasterControl's contract organization change control software integrates and streamlines the entire change control procedure for faster turn-around. It offers a best-practice form that incorporates priority level (by identifying the change as routine or temporary or emergency), as well as escalations. Plus, reports provide real-time status for all change control tasks.
Training not Integrated with Change In a manual system, it is difficult for employees to keep up with all the changes in SOPs, policies, and other critical documentation because the training process is not connected to the rest of the quality system.		Integrates Training With MasterControl, contract organization change control system can be integrated with the training application. Any change to a document that warrants new training will automatically invoke training tasks. MasterControl can automate the process of distributing online exams with the training, and even includes automatic grading.

Features of (CRO) Contract Organization Change Control Systems

Change control is a complex process, but MasterControl's CRO change control software can help contract research, labs, and manufacturing organizations standardize and simplify change control procedures in order to increase efficiency and effectiveness. MasterControl Change Control includes:

Best-Practice Form A pre-configured, multi-page form helps collect and track data every step of the way in the change control process: submission, evaluation, approval/ rejection, implementation, verification, and close of project.

• A section in the change submission form captures such information as: description of change, justification, and impact. Both original and revised documents can be attached for easy comparison.
• An initiator can use one form for multiple changes, depending on how many documents/items are affected by a change. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process.
• The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment in the contract organization change control software. It also asks for classification of the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing.
• The ability to prioritize is incorporated because the form asks the initiator to categorize the change submission as routine or temporary or emergency.
• Additional forms can be customized based on the company's special needs.

Form-to-Form Launching A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) 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 the change. Relevant information from the CAPA form will be automatically entered into the change submission form within the CRO change control system, reducing data entry. It also shows the history of the entire process.

Document Approval via Forms The change submission form and the documents linked to it can be approved all at once, avoiding repetitive steps.

Dependent Routing Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates the relationships between dependent processes.

Dynamic Organizers MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use and dynamic tool for easy search and retrieval of documents. All SOPs and other documents related to a particular change can be grouped together. MasterControl's contract organization change control software allows users to create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.

Powerful Reporting Tool Data can be grouped together by a date interval and then charted over a date range in the CRO change control software. For example, the number of customer complaints that have led to a change can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc.