Complying with regulatory and legal requirements is critical to modern companies. Any lack of traceability and accountability can harm your brand image and become an extremely costly mistake.
Meet the technical requirements of internationally-recognized standards like ISO with off-the-shelf software. Meet industry best practices of traceability and comply with even the most stringent of regulations.
Manage accurate and complete copies of your records. Maintain correct, truthful and reliable information. Retain all revisions and information from your electronic records, including audit trails and metadata. Keep a trail of your staff’s activities regarding documents, non-conformities, and training.
Access a summary of information related to your documents and activities like: author, date created and date modified.
Control your GxP data and generate an independent copy that contains local information of all the actions that altered the record.
See your files evolve, track how they have changed, see who changed them and make sure everyone has access to the right version.
Comply and exceed international regulations, even the most stringent regulations. Reduce audit time and focus on continuous improvement.
Comply with FDA's electronic signature requirements and verify data integrity.
Store your files in the same cloud as 70% of the Fortune 500 companies.
Limit information exposure and vulnerabilities by tracking print copies.
Connect your non-conformances and complaints with your document control.
CFR Part 11
Audit Log
Approval Log
Application Logs
Access Control
Distribution Control
Print Control
Document Grouping
CAPA Grouping
Training Grouping
Match your documents, activities and training initiatives to a specific norm and process. Information grouping and sorting can reduce your document audit times by up to 40%. Create a comprehensive document structure and ensure seamless internal and external audits.
Control your documents throughout their lifespan. Create, modify, review and distribute documents in an employee-friendly way.
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Manage all non-conformities and gain a 360-degree view of your team’s plans, activities and resolutions, in a single location.
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Ensure your staff is always prepared for the job. Identify knowledge gaps, launch training initiatives and keep evaluation records.
Learn More →Search for documents and leverage the power of metadata to locate an asset by keyword, name or date, across multiple departments. Connect a specific document and non-conformity to a standard or process.
Connect your documents and records to a standard and point of standard.
Bring all your documents together according to specific processes and gain clarity.
