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Meeting Safety and Quality Goals with a Compliance Management System

February 15, 2017 / by Emily Ysaguirre


Quality and safety, regardless of industry, are not as far off from one another as you’d think. In fact, most organizations share long term goals and don’t even know it. Sure, short term goals may not always be the same, but in the long term they very well can be. In fact, how many of your goals are to maintain a culture of integrity, compliance and consider the needs of customers and stakeholders?

With that said, an effective organization is likely to share both a safety and quality cultural mindset. In fact, for most manufacturers, having quality goods also means having safe goods and this is what makes industry goals very similar.

Compliance is the outcome of an organization meeting its regulations. Today, this is made sustainable by embedding training and software into already built systems of people and processes.

With automated software solutions, compliance organizations can reference data with faster and more efficient access and build reports by improving DI & DQ. In doing so, users can reduce the amount of free text content and use standard terms to make selections that have been vetted in terms of risk and historical evidence.

Compliance management software offers users:

Data Integrity

Data is critical to business and that is recognized within a compliance management system. A well manufactured data center offers a personal environment with dedicated features to the organization. A dedicated environment means that it there is a specialized and secure platform provided for data that is managed by firewalls, uses Secure Locket Layers (SSL) and HTTPS protocols. It also means it is SOC 1 Type II certified, TRUSTe and EU-US Privacy Shield certified. Companies that use compliance management software have the ability to continuously monitor the security of the system and keep current on industry best practices, while providing updated security as needed.

Data Quality

Most in-house solutions require a dedicated IT staff to maintain and administer the system. With a cloud-based solution, this is not necessary. This means you can concentrate on more important objectives like running the actual business.

A cloud-based compliance management system provides a backup process from start to finish, in a dedicated environment.

Also available is:

Disaster Recovery— Automatically maintains a near real-time replica of environment using N+N redundancy so that users can recover from loss of environment in 4 hours. Regular disaster recovery tests are performed to verify projected recovery times and data integrity.

Daily Data Backup— All data is backed up redundantly in multiple geographically segmented and secure online data centers and undergo systemic data integrity checks. On request, users can have current environments replaced with a backup version within 4 hours. Regular backup restore tests are performed to verify projected restore times and data integrity.

Audit Readiness

Regulated organizations benefit from maintaining 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 within a moment’s notice. Audit management, built with traceability of events in mind, allows users to demonstrate compliance within any audit or adverse event and display a report of root cause, action/s taken and the verification of effectiveness. This is extremely important when reviewing compliance processes within an auditor and the information is readily available.

Data is critical to business within a safety and quality cultural mindset. Automation helps to meet specific needs and maintain data by adding traceability into the mix. This allows users to run regular business practices and have the ability to create a seamless story of compliance from event detection to event correction. In fact, by practicing safety and quality through automated solutions, users can comply with auditors from start to finish with the ability to report on hazards and observations almost immediately.

Learn how to achieve GMP compliance in the cloud

Topics: Life Sciences