An effective compliance management software can help compliance managers and other employees in regulated organizations effectively navigate changing laws, regulations, standards and internal policies. More specifically, the right software can help companies maintain compliance with FDA and GMP regulations. It can also eliminate non-compliance risks by allowing them to:
Organize important compliance documentation.
Run risk assessments on compliance-related changes to prioritize implementation efforts and identify gaps in compliance.
Demonstrate ongoing proof of compliance.
Use automated workflows to simplify task, notifications and processes.
Easily manage compliance changes throughout the organization.
Simplify ongoing compliance training and testing.
Regulatory compliance software systems can facilitate sustained compliance through comprehensive document and quality control. This can:
Gain full visibility into compliance activities and regulatory requirements to trach changing costs, policies, controls, processes and more.
Maintaining compliance can be complex and time-consuming. The right software can automate these tasks, thereby streamlining complex processes, eliminating errors and minimizing the burden on compliance managers and IT teams.
Sustaining ongoing compliance difficult: regulatory requirements can vary drastically based on the type of operation and equipment, and factors like globalization, higher transparency expectations and increased emphasis on innovation have made it even more complicated. The right tool can automate tasks, notify you of changes and drastically reduce human error.
Through centralization and tools like electronic signatures, training and digital workflows, the right tool can facilitate version control, reduce human error and maximize accountability throughout the compliance process.
A searchable file repository, built-in compliance monitoring and a consolidated view can help simplify and streamline compliance management.
Proactive monitoring and automations can enhance compliance, reduce time spent on complex tasks, reduce errors, streamline system validation and more.
Ongoing risk analysis can help identify and eliminate gaps in validation and compliance efforts.
Easily integrating relevant documentation and systems can further streamline efforts and mitigate compliance risks.
When a user wants to make a change to a controlled document or submit it for review in Meridian Cloud, they initiate a controlled workflow to make that change. This forces documents to move through a defined workflow, which can prevent duplicate documentation and help ensure that all important steps are followed.
Every time you view, modify or print a GMP document in Meridian Cloud for Life Sciences, a print stamp and watermark will be automatically generated by the system on each PDF rendering of the document to provide key timing information and status updates. This can help maintain consistency of work across time zones and help employees understand,at a glance, which document is the latest and most up-to-date version.
In Meridian Cloud, electronic signatures are automatically required when a GMP document is put into a workflow. Each person that must provide their electronic signature will receive an email letting them know that there is a document ready for their review. As each user reviews or approves the document, their electronic signature is manifested on the PDF rendition of the document in the order they signed. This can simplify audit logs, facilitate digital workflow routing and maximize safety and quality by making sure that the right people have viewed the right documents at the right time.
Along with the print stamp, users will also see a watermark across each document showing that document’s status. For both Office and CAD documents, a handy compare tool easily highlights what changes have been made between versions. In addition, when a new revision is created, the prior revision is automatically watermarked as “superseded” to ensure that only the current version is referenced.
A clear and accurate audit trail makes the entire auditing process easy and intuitive, helping organizations:
Meridian Cloud for Life Science is backed by Accruent Managed Service, which provides ongoing validation-as-a-service. This includes ongoing risk assessment and management to ensure that your systems and processes never fall out of compliance.
