As a critical staple of electronic documentation, audit trails are used to ensure the integrity of documents. MSB’s in-depth audit trails enable data integrity; keeping your records verifiable, trusted, and secure.
Physically storing all the paperwork that comprises an audit trail is costly and cumbersome. The retrieval process of improperly managed documentation can be a paperwork nightmare.
A paper audit trail presents many challenges when it comes to liability. Maintaining paper means you risk documents being lost or damaged—compounded with a lack of secure backups!
Audit trails are the key to ensure legal enforceability of digital signatures. Paper-based audit trails are susceptible to human error and can be easily tampered with.
This is required to guarantee traceability, leading back to the record directly. Often this will be the record’s unique ID.
An accurate date and time stamp is critical in maintaining record integrity. It also plays a key part in defense against record falsification and fraud.
Details the sequence of events that took place in the document lifecycle. All values that are applied to a record must be present in the audit trail.
Traceability requirement ensures the ability to identify the user who created, deleted, or made changes to the record at hand.
Depending on the regulations related to your document, an audit trail might require a log recording the reasons why a document was changed.
MSB prioritizes data integrity in accordance with GxP guidelines. This ensures that your records are legally defensible and comply to critical industry regulations
Each signing activity is timestamped to record key information such as creation, modification, and approval. These timestamps protect your documents from human error.
MSB’s comprehensive audit trails ensure all signatures are traceable and enforceable.
GSK partnered with MSB to streamline their processes, cut down on turnaround time and reduce costs.
MSB’s comprehensive audit trail served to ensure both FDA and HIPAA compliance while reducing time spent on reviewal processes and providing convenient, secure storage.
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For an audit trail to be 21 CFR part 11 compliant it must track all “operator entries and actions that create, modify, or delete electronic records.” This includes user identity, document creation as well as modifications and deletions to the data.
Event logs note system level events, such as errors and outages, as well as administrative changes. This information alone does not meet the requirements of 21 CFR Part 11. An audit trail, however, records any and all changes made to system data.
MSB provides a pain-free method to access and review audit trail information. All actions, identities, and timestamps are available within the “activities” tab of each ePak within the system. We also provide an audit trail report within each document ePhotocopy.
Find out how MSB can provide your organization with a secure and accessible audit trail.
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