Document Collaboration Software Systems
MasterControl's document collaboration software system helps companies maximize their intellectual assets by automating, simplifying, and optimizing the process of collaboration in documents-based projects.
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A document collaboration software system offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost-effective.
Here's how MasterControl addresses key issues faced by companies in implementing collaborative projects.
Deviations Management Challenges | MasterControl Deviations™ Software System |
| Disconnected Deviations Processes A paper-based or hybrid deviation system, which consists of disconnected processes, faces a significant challenge in enforcing uniform incident response. The scope of a deviation is usually focused on a single event, rather than a series of events over time. Trends and patterns in occurrence remain hidden, so the quality system fails to make best use of available data. For example, a paper-based system may overlook repeated occurrences of deviations from release specifications or material specifications over a span of 30 days, and consequently fail to alert managers about the need to investigate it, or perhaps launch a corrective/preventive action (CAPA). | Connected Processes The deviations software from MasterControl is a part of the MasterControl integrated suite, allowing connectivity with other MasterControl applications that control other quality processes, including CAPA, OOS, and electronic batch record management. For example, deviation incidents can be correlated to nonconformances and customer complaints. MasterControl leverages the data collected for use in continuous quality improvement required by the FDA. |
| Poor Tracking of Deviations It's time-consuming to physically track paperwork. A manual deviation system makes it almost impossible to identify and avoid bottlenecks. | Automatic Tracking of Deviations Deviations software tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify bottlenecks and understand the sequence of events during processing. |
| Poor Turnaround For those with paper-based systems, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process, even if that deviation system involves a small group. | Faster Turnaround The deviation software from MasterControl tracks all routing information and data entered into the electronic form, allowing the deviation owner to identify bottlenecks and understand the sequence of events during processing. |
Compliant with Document Collaboration Software Systems
Regulatory compliance requires collaborative work in different levels. MasterControl streamlines and optimizes the collaboration process needed in any compliance effort.
- Automates Tasks: Our document collaboration software automates all tasks pertaining to collaborative projects, including notification, follow-up, escalation, and approval. Automation helps simplify the compliance environment, making it easier to stay compliant.
- Automatic Life Cycle Management: MasterControl provides secure virtual vaults for effective management of the collaboration life cycle. For example, a document will reside in the "draft" vault while team members are working on it. The document automatically moves to the "released" vault once it's approved. When a released document is revised and the revision is approved, the original document automatically moves to the "archive" vault in a document collaboration system.
- Enhanced E-Signature Functionality: Documents can be approved electronically. Signature manifestation (name, date, time, and meaning of electronic signature) can be appended automatically to each document as required by FDA's 21 CFR Part 11. The e-signature can be configured to include a user's title and the route step name in the manifest to distinguish the different kinds of approval a document gets (e.g., format approval made by a document control specialist vs. procedure approval made by the quality director).
- Part 11-Compliant Features: In addition to electronic signature capability, our document collaboration software system provides time-stamped audit trail and security features that meet 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
- Revision Control: Automatic revision control ensures that only the current version of a document is available, so users will not make the mistake of using obsolete or unapproved documents. Only one authorized user at a time can revise the document so there are not multiple versions available.
- Draft Retention: A company can choose to either retain or expunge drafts during the collaboration process depending on its policy.
Connected Document Collaboration Software Systems
MasterControl connects the collaboration process with other quality processes to promote continuous improvement.
- Web-based Platform: MasterControl is Web-based so it can connect all users involved in a collaborative project from virtually anywhere.
- Integrated Quality Management: MasterControl Document Collaboration can be integrated with other MasterControl applications and solutions for a holistic approach to quality management. This connectivity helps streamline workflow, increases efficiency, and helps ensure that quality issues don't fall through the cracks. For FDA-regulated companies, implementing an integrated solution also means system validation can be performed just once.
- Integrates with Existing Repositories for Optimization: Integration of MasterControl with existing document repositories and enterprise applications (ERP, LIMS, etc.) can be made easily and immediately, without expensive custom coding in document collaboration software systems.
Complete Document Collaboration Software Systems
MasterControl offers robust software, plus the appropriate tools and services necessary for successful implementation and validation.
- Continuous Validation: For FDA-regulated companies, MasterControl's document collaboration system offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ.
- Product Training: MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl's state-of-the-art Training Center in Salt Lake City and also at customers' facilities.
- Technical Support: Choosing MasterControl's document collaboration software system means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.
The QMS Provider for the FDA
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.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
