GMP Compliance Software

Verse was developed to help companies comply with regulations to GMP, ISO and FDA standards and initiatives, creating unparalleled visibility and control over critical GMP compliance practices.

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Integrated GMP Compliance Audit & Software Solution

In the Life Science industry, regulatory compliance is a critical driving factor towards automation of business systems. The FDA has placed significant oversight on adherence to specific requirements around compliance with Good Manufacturing Practices (GMP), 21 CFR Part 820 and Part 11, among others. This oversight has led companies to strive for transparency in their compliance processes. With the increased complexity of business, the need for GMP Compliance Software is growing.

You need to ensure your business needs are met. To do this you need software that has been created with your industry’s specific needs in mind. Solutions like Complaints Handling, Corrective Action, Risk Management, and GMP Audit management will ensure the best compliance process possible. Each module is designed to be interconnected and inherits information from one process to the next. The result is a seamless “story of compliance” from event detection to event correction and continuous improvement.

Fostering an Audit-Ready State for GMP Regulatory Compliance

Part of the goal of a regulated organization is a state of “audit readiness.” This means that when audited internally or externally by the FDA, the organization has the processes and documentation in place to pass any GMP compliance audit. Verse is built with traceability of events in mind; you can demonstrate GMP Compliance in an audit from any adverse event and display a report of the root cause, action taken and verification of effectiveness. This is extremely important when reviewing your compliance processes with an auditor—the information is literally at your fingertips.

Simply put, Verse has the tools you need to make sure you comply with regulations and stay on top of reporting and recording adverse events.

Risk Management and Closed-Loop Corrective Actions

Beyond tracking and tracing compliance from beginning to end is fostering the ability to make systematic, objective decisions. Using the Verse risk management tools, you can filter adverse events by their risk, focusing first on the most critical events. This improves efficiency and productivity, and ensures that you're staying on top of high-risk events.

You can also close the loop with your corrective action by generating risk-based reports, to look for areas for improvement—thereby building a true closed loop on effecting change with your GMP Compliance system. Mitigates risks with CAPA

Meeting the needs of Validated Compliance

Part of the requirement of any GMP Compliance Solution is ensuring the software is validated to run the way it was intended. Verse solutions are validated and tested to ensure compliance, and any changes made to the solution can be validated with the Verse Validation package to ensure you are meeting regulatory requirements.

GMP compliance audit requirements include validation as a component, and with Verse, you are able to create a centralized, cloud-based, validated solution for GMP compliance.

“[We received] tremendous support from the Verse team to assist Care Innovations in our implementation, on-going training sessions, direct access to technical leads who know their product and commitment from the CEO to support us really affirmed our decision.”

Cheryl Kiyama

Director of Quality and Production Operations, Care Innovations

Read the Case Study

Gain Visibility into the Data

Without visibility, it’s hard to improve compliance. Verse has a comprehensive reporting engine that lets you manage reports, create alerts and build out detailed charts and graphs. You can easily search and filter on the data, build templated reports, and conduct analysis on trends within your GMP Compliance System.

Generate regulatory reports to submit to agencies like the FDA or produce during a GMP audit or inspection. In short—gain visibility and impact change in your GMP system. Generate reports and corrective actions

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Automate Compliance with Verse

Audit Trail

Verse securely and automatically posts any and all field changes to a separate database. The Audit Trail includes the field’s old value, new value, name of the user who made the change, and date and time:

  • Can be enabled for specific phases or fields
  • Can be saved as MS Excel Spreadsheet
  • Includes user name and ID, date and time, record phase (reason for change), old data, new data, and comments
  • Track changes to user accounts (i.e. update, enable, disable) in the Audit Trail
  • Track changes to field values in the Audit Trail
  • Configuration Management: Ability to track changes made to configuration settings within the application in the Audit Trail

Electronic Signature Binding

Verse ensures that the user has signed into the system and exposed their signature via the forced authentication process, as required by 21 CFR Part 11. Authentication is required each time a document is processed:

  • Electronic Signatures and Records: displays the user name (Signer), ID, Record Phase, Activity and/or Event, and meaning of the signature
  • Secure access using SSL encryption
  • User name and password is used to verify 21 CFR Part11, Electronic Signature
  • Authentication required to access any part of the system
  • Configurable password expiration dates (expire password after X number of days)
  • Administrator access level can be defined to set up security
  • Require users to change passwords when they log in for the first time/li>
  • Closed-loop system

Regulatory Compliance and Validation

Comprehensive validation documentation is an integral part of the Verse solution, and we provide you with extensive documentation and the scripts necessary to validate your Verse solution:

  • Comprehensive Validation package available
  • Make specific events require a comment (i.e. must provide a comment for all rejected, archived, restored actions)
  • Allow access to all records until they are no longer needed
  • Records can be displayed on screen, in reports, electronically, or exported into a flat file format
  • Activities can be restricted to a designated person
  • Send records with different access control rules to separate archives for purging or classification
  • Create workflow configurations to enforce record routing
  • Keeps a record of every version of an attachment when it is modified

Securely Situated in The Cloud

As a cloud-based GMP Compliance solution, there is a certain degree of security required to ensure that the solution meets your needs. Verse is TRUSTe and Privacy Shield certified, SOC Type II compliant and provides multiple environments for developing, testing and promoting validated environments to production.

gmp compliance

Our managed services help to ensure maximum uptime and data backup. From enhanced security to redundancy to disaster recovery and backup, Verse is the most secure solution for cloud-based compliance.

Not only is Verse validated and secured in the cloud, but it also provides the highest level of security to meet your requirements. Verse is built upon one of the most robust and secure cloud platforms in the industry, making your GMP solution safe, secure and reliable.

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