General
What customer audit standards does the system support?
Is the configuration for suppliers or manufacturers?
How does this compare to enterprise QMS platforms?
Is SharePoint naturally Part 11 compliant?
Why utilize cryptographic signatures instead of third-party tools?
What validation documentation is included?
What happens during Microsoft 365 downtime?
How long does system implementation take?
Does the system support multiple languages?
Can the configuration manage multiple customer requirements simultaneously?
What are common ISO 9001 mistakes?
How to use document control?
What is document control in ISO 9001?
Which software is best for document control?
What are the four types of control systems?
What are the top 5 document management systems?
What are document control systems?
Audit
How often should you review an audit trail?
What is the most important element of audit trails?
Who is responsible for maintaining an audit trail?
What is the penalty for not having an audit trail?
What are the best practices for audit trails?
How to preserve an audit trail?
What are the four different types of audit trails?
What is an immutable audit trail?
Training
Lifecycle Management
What are the stages of document management?
Does Office 365 have a document management system?
Can I use SharePoint as a document management system?
What is the difference between document control and document lifecycle management?
Why do document lifecycle failures cause so many audit observations?
How does document lifecycle management protect approved supplier status?
How does ValidaPoint handle lifecycle management across multiple regulated customers?
SOP Approval
Can the system manage SOP approvals across multiple regulated customers?
How does a validated SOP approval process protect approved supplier status?
What happens when an SOP needs to be revised?
How many people should approve an SOP?
What makes an SOP approval non-compliant under FDA and EU GMP?
What is an SOP workflow?
What is standard operating procedures approval?
Copy Management
Can the system manage controlled copies across multiple regulated customers?
Does the system control both electronic and paper documents?
What are the most common controlled copy failures in supplier audits?
How does controlled copy management protect data integrity?
Why do uncontrolled copies generate such significant audit findings?
What is the difference between controlled and uncontrolled documents?
What documents need to be controlled for ISO 9001?
What is a controlled document management system?
What does "controlled copy" mean?
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7.162 36.118 7.162 C 36.334 7.162 36.549 7.216 36.845 7.244 C 37.114 7.326 37.276 7.38 37.41 7.49 L 37.491 7.572 L 37.491 5.139 L 37.437 5.112 C 37.276 5.002 36.926 4.948 36.522 4.948 M 43.062 4.893 C 41.393 4.893 40.048 5.385 39.106 6.396 C 38.137 7.38 37.679 8.747 37.679 10.469 C 37.679 12.082 38.164 13.394 39.079 14.351 C 39.994 15.28 41.259 15.772 42.82 15.772 C 44.462 15.772 45.78 15.28 46.722 14.269 C 47.691 13.257 48.149 11.918 48.149 10.251 C 48.149 8.61 47.718 7.298 46.803 6.342 C 45.915 5.358 44.65 4.893 43.062 4.893 M 44.973 12.875 C 44.542 13.449 43.843 13.749 42.954 13.749 C 42.093 13.749 41.393 13.476 40.882 12.847 C 40.398 12.273 40.155 11.426 40.155 10.36 C 40.155 9.267 40.424 8.419 40.882 7.818 C 41.366 7.216 42.066 6.916 42.927 6.916 C 43.789 6.916 44.435 7.189 44.919 7.79 C 45.404 8.364 45.646 9.212 45.646 10.305 C 45.646 11.399 45.43 12.273 44.973 12.875 M 53.478 9.431 C 52.724 9.103 52.24 8.856 52.024 8.665 C 51.836 8.474 51.755 8.228 51.755 7.872 C 51.755 7.599 51.863 7.298 52.132 7.134 C 52.401 6.97 52.724 6.861 53.182 6.861 C 53.585 6.861 54.016 6.943 54.42 7.052 C 54.823 7.162 55.2 7.326 55.496 7.544 L 55.577 7.626 L 55.577 5.33 L 55.523 5.303 C 55.254 5.194 54.877 5.084 54.447 4.975 C 54.016 4.893 53.585 4.866 53.262 4.866 C 52.132 4.866 51.19 5.139 50.436 5.768 C 49.71 6.342 49.36 7.134 49.36 8.064 C 49.36 8.556 49.441 8.993 49.602 9.349 C 49.764 9.704 50.006 10.032 50.329 10.333 C 50.652 10.606 51.136 10.907 51.809 11.18 C 52.374 11.426 52.778 11.617 53.047 11.754 C 53.316 11.891 53.478 12.082 53.612 12.191 C 53.693 12.328 53.747 12.519 53.747 12.765 C 53.747 13.449 53.235 13.804 52.186 13.804 C 51.782 13.804 51.351 13.722 50.867 13.558 C 50.383 13.394 49.898 13.148 49.521 12.875 L 49.441 12.793 L 49.441 15.171 L 49.494 15.198 C 49.844 15.362 50.275 15.472 50.786 15.608 C 51.298 15.69 51.755 15.772 52.159 15.772 C 53.397 15.772 54.42 15.499 55.119 14.87 C 55.846 14.269 56.25 13.503 56.25 12.519 C 56.25 11.836 56.061 11.207 55.658 10.743 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Audit-Ready Document Control for Microsoft 365
ValidaPoint configures Microsoft 365 as a GxP-compliant document control system.
ValidaPoint runs on infrastructure certified with ISO 27001 (Microsoft Azure), ISO 9001 (Microsoft Azure) and SOC 2 Type II (Microsoft Azure)