21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software

1. eInfotree Access Module

2. 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

3. 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.

4. 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.

5. 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.

6. 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

7. 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

8. 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

9. 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.

10. Contact Us Boston (Corporate Office) TEL: +1 (978) 464 9180 234 Littleton Road Westford, MA 01886, USA New York TEL: +1 (978) 496 7230 394 Broadway New York, NY 10013