DQ Documentation

Main Process

 

The design qualification (DQ) is a review of system design and documentation for technical content and quality. It is usually performed prior to installation at the site. Bespoke systems require a full DQ, whereas standard systems like SAP require a much simpler DQ.

The purpose of the DQ is to:

• Confirm that the system development life cycle has been followed
• Ensure that the individual elements of the system have been designed and proven
• Ensure that the user and supplier agree that the integration of all the elements meet the user requirements specification, functional specification, design specification, and quality plan

The results of the DQ should be documented in the DQ protocol. The report should also include:

• Details of tasks done during the DQ
• Supporting documentation
• Version numbers or dates of documents reviewed

Represents prepackaged business expertise in the form of methodology, documentation, and reliable preconfiguration for SAP Business Suite solutions. All the experience from SAP and its partners are encapsulated in this package. New and existing customers and partners in all project types and phases can use SAP Best Practices. They save time and money and help you get your solution on a fast and safe track.

Tools

• SAP Best Practices for Pharmaceuticals

Is a platform that provides the integrated content, tools, and methodologies that you need to implement, support, operate, and monitor your enterprise's solutions in the pharmaceutical industry from SAP. These include:

• The URS documents are the descriptions of the functionalities that the customer wants to run in the system. These documents can be managed with SAP Solution Manager.
• The roadmap of SAP Solution Manager supports the full documentation of the different phases of the project, including predefined accelerators with versioning and status management.
• The business blueprint phase of SAP Solution Manager allows the management and documentation of all kinds of templates, documents, etc., with versioning, status management, and definition of electronic signatures.
• Platform which integrates content, tools and methods for implementation, support, operation and control; enables central administration and control of allocated, decentralized applications, and provides automatic functions for evaluation of problems.

In the attached GMP functionality matrix, an overview is given of the Pharmaceutical CGMP 21 CFR Part 211 regulations and the modules in the SAP R/3 system.

Tools

• GMP-functionality matrixes

GMP-Functionality Matrix

• Available in the SAP White Paper "Complying with U.S. FDA Title 21 CFR Part 11 - Electronic Records, Electronic Signatures, Final Rule"
• Alias "pharmaceuticals"

During the project preparation phase, the workload of the validation must be defined. Validation must only be executed when the requirements exist and the process has a critical level. This information must be acquired in an assessment. SAP can provide a selection of the GMP-critical transactions.

Tools

• Selection of GMP-critical transactions

Selection of GMP-Critical Transactions

• The list contains a selection of possible GxP-relevant transactions, including change document objects and tables, and makes no claim to be exhaustive.
• #Alias "pharmaceuticals"

Gives you a general idea of how your business processes could be mapped in one or more SAP systems. Documents in detail the scope of business scenarios, business processes, process steps, and the requirements of a SAP Business Suite solution implementation.

Services

• Business Blueprint

A lack of time, money, and know-how often prevents companies from paying close attention to the security of their SAP R/3 system and its hardware and software environment (database, network, and operating system). The security must be examined, and possible weak spots should be eliminated.

SAP Security Consulting Services will help customers improve their system security significantly through security checks and reviews or by support in designing and implementing a company-specific SAP R/3 security.

Services

• Security

For special processes, additional functionality can be required by the customer. For quality assurance review or for support in the developments, the GCDS department at SAP helps the customer.

Services

• Development Quality Assurance