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.
Challenges in Document Collaboration
Document Collaboration System Solution
Limitations in Time and Place:
Having brilliant people in your team is not enough. You still have to bring them all together. Since these people have many responsibilities, their inability to meet is an obstacle in collaborating successfully which is easily catered by a document collaboration system.
Virtual Collaboration Space:
MasterControl's document collaboration software system provides a virtual workspace for collaboration. Team members can review, comment on, revise, or approve a document without having to be physically present with the rest of the team.
Collaboration under a manual system involves passing a document around physically or via e-mail. When a team member is unable to act on it, the document languishes in that person's desk or e-mail "inbox," causing delay and MasterControl's document collaboration system makes it easier to transfer and share document.
Automates tasks pertaining to collaborative projects, including routing, follow-up, and approval. Escalation is automatic so after a period of inaction, the document moves on to the next person in line. MasterControl avoids duplication of efforts by allowing participants to see other people's input.
Lack of Revision Control:
In a paper-based or hybrid system, there could be multiple (unwanted) versions of documents. Modifying a document also entails time-consuming meetings and manual change.
Automatic Revision Control:
MasterControl's document collaboration software provides automatic revision control to ensure that only the current version of a document is available. Also, only one authorized user at a time can revise the document so there are not multiple versions available.
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.