How can Title21 Solutions Help You?
Ensure Compliance
Translate to improving your inspection and audit outcomes. Are you tired of the seemingly endless hours spent on collecting data from multiple places to get compliance data you need? Title21 keeps your processes in control and your documents organized, so they are easily accessible the next time you need them. You will no longer have to ‘prepare’ for an audit or inspection. You will be able to keep timelines and escalate issues to conduct your business in a FDA-friendly manner every day. Title21 Software supports 21CFR Part 11 compliance (Electronic Records and Signatures) that includes a full audit trail of all record changes. Title 21 Software helps support compliance to many regulations including FDA, GxP, AABB, ISO 9001, CAP, HIPAA and more.
Improve Performance
Accountability and visibility are difficult with a paper-based system or a patchwork of separate and limiting point solution products. Paperwork is often misplaced or lost. Finding a particular document in approval routing often takes hours or days to locate. With Title21 Software, now each person in the system can work from their own customized “personal dashboard”, displaying items they are responsible for, due dates, length of time they’ve had the task, overdue items, etc. Supervisors can quickly view the dashboard of their subordinates, or have e-mails automatically sent to them alerting them of their subordinates’ overdue tasks. Accountability and visibility become crystal clear.
Optimize Efficiency
Central and Accessible - Most companies have multiple copies of documents and SOPs housed in numerous locations. Title21 Software allows documents to be accessed from any location, even remotely, without the need to be printed, archived and discarded. Title21 Software gives the users the ability to search for files in several user-friendly ways, so there is no time wasted searching for a particular document.
Achieve Harmonization
Best Practices - Help reduce complexity and helps leverage best practices across your organization. Title21 Software helps centers and labs manage SOPs across different departments, permitting a core set of documents to be shared across the organization, while still allowing individual departments to use and maintain their own documents. Title21 Software can fulfill requirements for both consistency and flexibility. Blood centers and labs can take this opportunity to improve and harmonize their forms and processes to capitalize on all the benefits of Title21 Software’s system.
Increase Productivity and Capacity
Operational Excellence - can maximize profitability by increasing productivity, building capacity and reducing wastage. Do you find yourself wasting time to get the data you need for your inspection results? With Title21 Software, you can reduce human error through form, field and cell validation. Automated detection and notification of adverse trends allows you to get ahead of issues before they cause problems. A powerful automated system empowers users through easy-to-use queries and data organization capabilities. Do you have trouble interpreting your spreadsheet results because they’re not in a graphical format to view easily? Management can stay informed through automated report generation with e-mail distribution.
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