21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software
                     eInfotree 
Access 
Module
eInfotree Access Desktop
Access databases are commonly used in support of critical GxP applications. 
Examples of these include:
• Batch, product or test data
• Clinical trial data
• Raw material, in-process, and finished goods test data
• Manufacturing logs
• Assay test data
• Training records
• Records required by predicate rules (GCP, GMP, GLP)
Access databases usually have little to no security, and hence the data can be 
easily modified by unauthorized users potentially compromising data integrity 
and compliance. Unauthorized changes or errors, in a GxP environment, can 
lead to serious consequences including improper release of a batch, erroneous 
clinical trial results and falsification of records. Hence, Access databases used in 
support of predicate rules must be 21 CFR Part 11 compliant to comply with 
FDA regulations.
Benefits
• No change in the user experience – the database can still be opened as 
before by simply double-clicking the file name.
• No need to move the database to a different location.
• Simple and effective remediation of Access databases for 21 CFR Part 11 
Compliance.
• Save time and money by eliminating the need to migrate to a new system.
• Files continue to be saved in the native Access format.
• Quick and easy installation of software.
• Automated and structured process provides confidence in spreadsheet 
controls and process integrity to aid in attestation.
• A dedicated server is not required.
• Easy to configure, use and maintain.
• Reduced validation effort using an available validation package.
Features
Audit Trail
• Records date, time, user ID, full user name, table name, field name, form 
name, action type, old value and new value
• Configurable reason fields
• Fully secure and protected
Electronic Signatures
• Transactions requiring e-signatures configurable by action type and form
• Includes the user id and printed name of signer, date, time and e-signature 
meaning
• eSignature meanings are configurable
• Signatures not performed during a single, continuous period of controlled 
system access require all e-signature components
Security
• Integrates and enforces Access workgroup security
• Enforces minimum length and composition of passwords
• Password aging forces a new password after configurable intervals
• Transaction safeguards include account lockouts after a configurable number 
of retries
• Loss management features allow temporary deactivation of user accounts 
and force a new password after a reset. Automatic session timeouts
About Us
With 25 years of experience and 8 of the Top 10 life science 
companies as clients, CIMCON Software supports 500 customers 
across 30 countries with 24/7 global coverage. Partnering with 
leading Cloud providers and vendors, it automates key processes—
data and document management, training, audits, and integrity 
assessments—while ensuring Part 11 compliance for Excel, Access, 
and legacy lab software.
Contact Us
Boston (Corporate 
OffiTcEeL): +1 (978) 464 9180
234 Littleton Road  Westford, MA 
01886, USA
New York
TEL: +1 (978) 496 7230
394 Broadway  New York, NY 10013