MSB Sets The Bar For Compliance With Secure Audit trails
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.
Key Challenges Of The Paper-Based Audit Trail
Storage & Retrieval
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.
Liability
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!
Enforceability
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.
Ingredients of an audit trail
Link to Record
This is required to guarantee traceability, leading back to the record directly. Often this will be the record’s unique ID.
Date & Time Stamp
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.
Original & New Values
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.
User ID
Traceability requirement ensures the ability to identify the user who created, deleted, or made changes to the record at hand.
Reasons for Change
Depending on the regulations related to your document, an audit trail might require a log recording the reasons why a document was changed.
Why MSB?
GxP Compliant
MSB prioritizes data integrity in accordance with GxP guidelines. This ensures that your records are legally defensible and comply to critical industry regulations
Time Stamp
Each signing activity is timestamped to record key information such as creation, modification, and approval. These timestamps protect your documents from human error.
Traceable & Secure
MSB’s comprehensive audit trails ensure all signatures are traceable and enforceable.
How We Helped GSK Evolve its Documentation Processes
MSB Assists GSK in Eliminating Paper
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.
View Audit Trails in Action with MSB
Accessing Audit Trails Within MSB
- MSB’s intuitive interface makes accessing and reviewing audit trails simple.
- All critical information is present within the audit trail including document ID, user ID, time stamps, actions, and details.
- MSB makes it convenient to trace and review signed original documents against the audit trail.
FAQS
What information is required within an audit trail?
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.
What is the difference between an event log and an audit trail?
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.
Is it difficult to review audit trail information?
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.
Contact Us
Find out how MSB can provide your organization with a secure and accessible audit trail.