More and more leading manufacturers are turning to enterprise software systems to manage all audit-related activities and integrate quality processes.
Audits allow companies to identify problems with their quality processes so they can conduct business as efficiently as possible. In regulatory environments, quality audit systems are especially critical since audits are required on an ongoing basis in order to improve product quality and safety and to ensure compliance with regulatory requirements. To meet these manufacturers' audit needs, MasterControl provides an audit software system that seamlessly connects the audit process with the entire quality system and allows users to conduct audits using a mobile device. Users of the MasterControl audit software also have the capability to enter audit information offline through Microsoft Word.
MasterControl Audit is an audit software system that has been specifically designed to automate and facilitate regular audits by making them faster, easier, and more effective. Because it connects the audit process with the entire quality system to form a comprehensive approach to quality management, it benefits all departments throughout the enterprise.
Not only does the MasterControl audit software system provide powerful analytics and reporting capabilities, but it allows companies to automate all recurring audit-related activities, integrate data, and launch forms (e.g., CAPA or SCAR) directly from an audit finding. Perhaps the most beneficial feature is the mobile functionality. Auditors can use mobile devices to complete checklists and create observations within the MasterControl system. They can also use a mobile device to enter header fields (such as scope and summary) as well as the audit start and end dates. They can also take an audit offline using the Microsoft Word add-on and complete header and observation details whilst working remotely.
Some of the other exciting and useful features of the MasterControl audit software system include:
Multiple Platforms: Audits can be performed - and responses can be collected - using multiple platforms in parallel. Users can write the audit summary and scope through the main audit system interface, switch to the mobile interface to enter observations, and then use the offline Microsoft Word option to capture responses. Another handy feature is that it allows one responder to add comments through the mobile interface while another responder is entering his or her responses in Microsoft Word.
Scheduling Made Simple: Audits can be scheduled ad-hoc, via automated planning, or using a completely risk-based approach. The filtering and grouping features of the MasterControl audit software system allow more control and flexibility over calendar views. In addition, there are "Tooltips" that provide quick visibility into audit details. The audit system also features drag and drop functionality that allows users to easily move audits or adjust durations.
Guest Responders: Observations can be assigned to external users using MasterControl's Guest Connect. This allows people who are not primary users of the audit software system to log in and provide responses via a secure portal.
Flexible Checklist Functionality: Checklists can be completed using the main audit system web interface, the mobile interface, or offline using Microsoft Word. Users can also define standards and criteria to create audit checklists.
Template Editor: Using a Microsoft Word add-on, the audit system's flexible template editor gives users complete control over style and layout for all audit documents such as audit reports, checklists, and memo or announcement letters. The built-in preview function allows users to see how the reports look before the templates are uploaded into the system.
Collaborate and Approve: Using the MasterControl audit software system's existing document collaboration and approval functionality, auditors can provide input and make changes on draft and final reports before submitting them for approval.
Who Benefits from the MasterControl Audit Software System?
The features and functionality of the MasterControl's system are especially useful to professionals such as:
QA Managers: QA Managers have to ensure quality across many aspects of an organization and they may have to reference and update information across many sources. MasterControl's audit system manages all these aspects to simplify the audit scheduling process and it provides a central repository for all audit data to boot. Ad-hoc audits can be created instantly and reoccurring audits can be planned for the future. In addition, integrating the audit system with the MasterControl Risk module can provide a full risk-based approach to audit frequencies and scheduling. QA managers also face complexities when managing multiple auditors' diaries, checking for conflicts, avoiding holidays, moving schedules when audit dates change, and so forth. The MasterControl audit software system simplifies these issues with an auditor availability function built directly in to audit scheduling, a conflict resolution function to highlight potential issues, and calendar emails that are sent directly to auditors and re-sent if dates change. Also, custom lead-times per audit type allow variable notice periods for auditors.
Responders: Using the MasterControl software, responders can receive observations on internal audits from multiple sources in multiple formats. The audit system acts as a single solution that handles response gathering from all audits using a choice of either offline, mobile, or a web-based platform.
Study Managers: MasterControl's audit software system provides a GCP study with automatically scheduled audits and an electronic GCP study record with an audit trail of data changes. By setting up audit planning, users can take advantage of the audit system's ability to provide an automatic schedule of audits that can then be included on a study audit certificate. In addition, audits can be routed based on the chosen audit type. As each audit is completed, it is available to be included in the final study audit certificate.
The information provided here is just a small sampling of the robust functionality of the powerful MasterControl audit software system. For more information about what MasterControl's audit system can do for you, contact a MasterControl representative by sending an email to firstname.lastname@example.org.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.