WHAT WE DO: DATABASE/IT

DATABASE/IT

Databases are used to track raw materials, maintenance schedules, manufacturing schedules and more. At Matrix Technologies, we design and validate these systems using GAMP methods. Following are several project abstracts that detail how we have been successful in this service area.

MMS EMPAC FUNCTIONAL SPECIFICATION

The scope of this project involved the development and generation of the Functional Specifications for client’s Maintenance Management System (MMS), Enterprise MPAC Application.

Enterprise MPAC (EMPAC) is an off-the-shelf, user-configured Computerized Maintenance Management System (CMMS) that is running on an Oracle server. EMPAC is used in conjunction with related applications that interface with the EMPAC tables to exchange data and help manage and maintain client’s asset-care activities. The combination of these applications are a part of client’s Computerized Maintenance Management System, which is known as MMS (Maintenance Management System).

This functional specification document applies to the EMPAC maintenance management software and its related applications.

Each application was thoroughly reviewed to specify functionality and determine if each function had potential to impact any of client’s GXP operations and/or processes.

MMS DATABASE VALIDATION

The scope of this project involved the generation and execution of the Maintenance Management System (MMS) Software Validation Protocol and the development of a validation summary.

MMS is an Oracle maintenance management system using Enterprise MPAC (EMPAC), and off-the-shelf CMMS, in conjunction with Oracle Forms and Web-based applications that write to EMPAC tables. The system is used to manage activities and data associated with the maintenance and management of client’s GXP and non-GXP facilities and equipment. This is performed through preventive maintenance planning and scheduling, work request and work order generation and processing, asset history tracking, inventory control and resource management.

The protocol was developed to meet client’s software validation requirements, which included compliance with 21CFR Part 11. The IQ included testing to ensure that MMS was properly installed and configured. The OQ testing included testing of security, asset and inventory record creation and maintenance, generation and processing of work requests and work orders, data integrity of information between the MMS applications, audit trail verification and concurrent access verification. In addition, this protocol also ensured that MMS performed in accordance with client’s requirements and that this performance was verified and documented.

Matrix was also responsible for trouble-shooting the system, identifying problems and coordinating the implementation of patches with the software vendor to remedy discovered problems. 

ACCESS DATABASE DESIGN FOR QUALITY SYSTEMS

The scope of this project consisted of the design, development and documentation of the following MS Access databases:

Both databases include audit trails and security controls to comply with 21CFR Part 11. The Inventory Control of Raw Materials database provides the user with the ability to allow for point of use inventory deductions for each material from the appropriate locations. The database has the capability to calculate the total quantity of inventory for each material based upon individual location and provides a running sum total of each material.

The Validation Protocol database supplies support for the daily functions of tracking the review and approval of validation protocols, reports and change control. It also provides support for all departments that rely on validation to provide validation status of equipment and equipment information.

Both databases include audit trail and security control programming. The security rights are based upon the access group assigned to each user. The audit trail captures changes to all the data fields in the database as well as new records created and old records deleted.

The following GMP documentation was also generated for all databases:

DISCREPANCY REPORTING REPOSITORY DATABASE VALIDATION

The scope of this project involved the generation and execution of the Discrepancy Reporting Repository (DRR) Database Validation Protocol, the development of a validation summary, and the generation of a Software Design Summary document.

The DRR Database is an Oracle database that is used as a centralized source for discrepancy data and provides a consistent and standardized way of extracting discrepancy related data for reporting purposes. The data is extracted from the source databases on a daily basis using stored procedures (load scripts) in the Oracle database. The load scripts perform formulas and data transformations during the loading of the repository to convert the data form reporting purposes. Users are then able to generate discrepancy reports via client’s network using Brio Enterprise OnDemand Server software.

The protocol was developed to meet client’s software validation requirements. The Installation Qualification (IQ) included testing to ensure that the DRR database software was properly installed and duplicated. The Operational Qualification (OQ) testing included testing of security, creation and transferring of discrepancy records into the DRR database, data integrity of information between the source database and the DRR database, field verification and concurrent access verification. 

Matrix was also involved in trouble-shooting the system and identifying problems with the design team to remedy discovered problems.