Overview
For all firms operating in today’s competitive and market driven economy are becoming increasingly focused on maximizing productivity and efficiently managing the compliance, while reducing their overall costs. The current validation and revalidation processes are predominantly paper based and manual. Unfortunately, in many cases, the traditional paper based process has become inefficient, time consuming, resource intensive and very expensive to manage. Inefficient manual compliance processes can stifle innovation, expose organizations to considerable compliance risk, and compromise the firm’s ability to respond and bring products to market in a timely fashion. Validation departments in the regulated firms are faced with the challenge of efficiently managing the periodic review and revalidation tasks by coordinating with other department stake holders. In the manual process, managing revalidation schedules is a complex task that is prone to human error. Managing an effective revalidation program to ensure that all of your critical GxP process, systems, instruments, equipment, etc. are revalidated on time is complex and difficult to maintain. Failing to revalidate critical GxP entities (Instruments, Equipment, Software etc.) and GxP Processes could result in FDA issued warning letters and citations.

“Systems and Processes should be periodically evaluated to verify that they are still operating in a valid manner”.

Source: ICH Q7A GMP Guidance

Benefits of Implementing eQual
By implementing eQual system, companies can achieve efficient revalidation program and ensures critical GxP Process, Instrument, Systems, etc. are revalidated on time and eliminate the possibility of missing the revalidation tasks due to human error. eQual improves coordination among various groups such as Quality Assurance, Technical Services, Validation, and Manufacturing etc. through configurable workflow to create periodic review and revalidation task schedules. Approval of any revalidation schedule between different departments is suggested to minimize the impact of revalidation activities that may have on production schedule. In addition, eQual helps organizations to improve the communication between the stake holders for the upcoming periodic review and revalidation schedule tasks.

Revalidation Schedule Creation
Revalidation Schedules can be created easily through eQual. Each revalidation schedule created is highly configurable allowing a user to specify the due dates, frequency of the revalidation, grace period, alert notification, and approval workflow. Through eQual, Revalidation Schedules are created easily as each revalidation schedule created is highly configurable allowing a user to specify due dates, frequency of the revalidation, grace periods and alert notifications.

Electronic Approval Workflow for Proposed Revalidation Schedules
Once a revalidation schedule has been created in eQual, it is routed through a configurable approval workflow. Upon approval of the schedule, the schedule will be automatically written to the revalidation schedule calendar. The selected user groups will be alerted of pending and delayed revalidation tasks through the Task Alert Feature and/or through the corporate e-mail system. By alerting groups of users, eQual eliminates the possibility of failing to revalidate critical GxP entities. The approved schedule will be available in the calendar for information for all the users corporate wide. The approved schedule can be edited with appropriate permission; the edited schedule will be routed through a configurable workflow for approval. Approval workflow improves the communication among various groups involved in the revalidation tasks. This would minimize the impact on production schedule or other planned tasks.

Dynamic Revalidation Schedule Calendar
Approved revalidation schedules are automatically written to a central revalidation schedule calendar. The revalidation schedule calendar can be viewed by the week, month or year. Group members can add note(s) in the calendar making the revalidation and periodic review tasks more collaborative.

Alert Notification
Selected Groups (groups selected at the time revalidation schedule creation) alerted of upcoming or Delayed Revalidation Tasks automatically through corporate email system. Set Number of Days to be alerted before and after revalidation task is due until the grace period with frequency of alert notification to ensure that revalidations are completed on time, the system will alert user groups of any revalidation task that is due or has passed the due date. The number of days before the due date, the number of days after the due date, and the frequency of alert notification is configurable on a per schedule basis. Each user in the user groups selected will be alerted through the system and through the corporate email system.

Reports
eQual is equipped with many standard reports that will provide you information regarding revalidation schedules and specific revalidation tasks.

Following reports are available out of the box with system:

1. List of revalidation tasks with status such as completed, scheduled, delayed, in-progress etc.
2. Revalidation Schedule Calendar
3. Inventory of Systems to be revalidated or under in revalidation schedule
4. Schedule under approval
5. Delayed revalidation tasks with associated CAPA details

Architecture
• Off-the-shelf software
• Fully configurable
• Web-based software

Compliance
eQual’s comprehensive feature set, developed by working with regulated companies, and trade organizations, makes it easy for companies to use while maintaining GxP compliance.

• Prevent missed revalidation task with Auto Reminder before and after the due date until the grace    period
• Controlled workflow for approval of the revalidation or periodic review

21 CFR Part 11
ValGenesis is a pioneer in providing validation automation system with electronic records / electronic signatures for 21 CFR Par t 11 compliance.

• Track all the activities with audit trail
• Configure the electronic signatures / electronic records settings to mandate use
• Design rules allow you to determine who can sign and for what purpose, and the order in which    signatures are required
• Different users can have different signing rights in different roles
• Security options can be enabled to enforce password expiration