Using MS Access in GxP Environments

With its relative ease to develop and use, MS Access is an ideal information management tool for a small company or department. The FDA and other regulatory bodies allow MS Access, so long as these systems are validated (21 CFR 11.10a) and have other technological controls in place to ensure that the database is compliant with 21 CFR 11.

Ofni Systems, a leader in MS Access validation, can ensure that your databases are compliant with all regulatory requirements and quickly and efficiently validate all of your MS Access databases.

Compliance with 21 CFR 11

A key system requirement for any computer system used in a GxP environment is compliance with 21 CFR Part 11. If your Access database does not already have the technological tools to be compliant with 21 CFR Part 11, we recommend the Part 11 Toolkit. The Part 11 Toolkit provides MS Access with audit trails, limited system access, password controls and other technological tools for compliance.

Validation Methodology

Step 1: Gather Functional Requirements.

Document the system functional requirements. Functional Requirements describe what actions the database must be able to perform. This includes:

Data to be entered into the database.
Actions performed by each form.
Identifying who can enter the data into the system.
Identify how the system meets applicable regulatory requirements.

Step 2: Document Design Specifications.

Design Requirements describe how the database accomplishes the functional requirements. Ofni Systems uses proprietary tools to analyze the database to create comprehensive design specifications. Design specifications include:

Inputs - Defining Data entry, validation rules, etc.
Processing - Workflow enforcement, documenting code and macros, etc.
Outputs - Reports, data exports, etc.
Security - User level security, data protection, etc.

Step 3: Develop and Execute Test Plans.

Once requirements have been outline and documented, Test plans are developed to demonstrate that all required system functionality is met and the system is properly secured. Our validation professionals will document a testing protocol, designed to demonstrate that your form meets all of your business requirements, plus regulatory requirements outlined by 21 CFR Part 11. As appropriate, this includes operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.

Throughout the process, a Traceability Matrix is updated to ensure that all system requirements are address. If necessary, a formal risk assessment can be created to document decisions to focus validation testing. A Summary Report is also created at the end of the process to summarize any issues found during the validation project.

Benefits of validating your MS Access database

Validating your Access program means all data can be used to make quality and GxP decisions or submitted to regulatory organizations like the FDA. You can query your data to better understand your business process. You also have increased confidence in your system, control over the data and who has access to that information.

Ofni Systems Computer Validation Services

Ofni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.

Ofni Systems uses FastVal to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods, with more time spent testing your software and less time preparing documentation. Our goal in all software validation projects is to improve the quality and value of your computer system.

Ofni Systems can validate all of your software, databases, spreadsheets and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. Ofni Systems will perform risk assessments to focus the validation effort on the most appropriate sections of your system.