Certification, Guidelines, GMP

Introduction > Certification

Information on

System-based inspection approach

ERES Requirements from global regulatory agencies
FDA Approval process:
- Stage 1: Process design
- Stage 2: Process qualification
- Stage 3: Continued process verification
- Audits and audit trails
- System validations
- Electronic signatures
- Documentation

EU GMP Annex 11: Computerized Systems
ANVISA (Brazil): ANVISA Resolution – RDC n. 17
PFSB/ELD Notification No. 0401022 of Japan
PHARMACEUTICAL CGMPS: A RISK-BASED APPROACH
OTHER INTERNATIONAL GMP GUIDELINES:
- PIC/S Guidance
- ICH Guideline
- Chinese State Food and Drug Administration
 
Functionality in Beas Manufacturing that may be regulated:

•Materials management

•Plant maintenance

•Production planning

•Production planning for process industries

•Quality management

•Sales and distribution

•Logistics execution

•Environment, health, and safety

•Human resources and training information

•Warehouse management

Central functions include:

•Batch management

•Handling unit management

•Document management

Cross-application components include:

•Engineering change management

•Classification

•Document management

•Electronic records (audit trail)

•Digital signature

•Notifications

•Records and case management

•Master data governance

Electronic records:

•Configuration within the implementation guide

•Transports and business configuration sets used to migrate configuration from one software system to another

•Master data such as the material master, vendor, resource, recipe, and customer

•Business processing objects such as purchase orders, process orders, and inspection lots

•Electronic records for business processes or transaction execution, such as material documents

•Electronic or digital signatures

 
Table Logging
Audit Trail
Date and time stamp
Electronic and digital signatures in Beas Manufacturing
Beas quality control, release and support process of patch levels – synchronized with SAP
GAMP5 – Software Category 4 (Configured Product)

Validation approach to achieve compliance:
- Conducting system compliance assessment
- Defining Part 11 requirements
- Defining the overall strategy in the validation master plan and determine how the system will be deployed as per software development life cycle (SDLC) methodology
- Conducting good practice assessments at the business process level
- Developing security authorizations according to SDLC. Establish functional requirements specifications for job

roles
- Configuring software to activate complete audit trail reporting and electronic signatures
- Testing the system
- Training users for all transactions within their profiles
 
Supported business processes:

•Make-to-stock, make-to-order, engineer-to-order / projects

•Assembly / configure-to-order / variant production

•Supply chain management process integration

•All mixed-mode types

Benefits of Beas Manufacturing:

•Above-average functional industry coverage and process support

•Quick, effortless and cost-effective implementation. Industry specifics are considered, integrated and available from the very outset.

•Best-practice process, including options for easily and flexibly modifying or adding integrated business scenarios to meet your individual business requirements/typologies across all process chains.

•Transparent process analyses (“inside views”) support companies in continuously reviewing the effects of optimization projects (such as lean manufacturing, improving product margins, etc.) using defined KPIs

•Use and integration of the latest technologies and innovations, from SAP ERP certified integration to SAP HANA and analysis applications, as well as SAP cloud and mobile solutions.

 
See examples to industry benefits and best practices in the Beas Manufacturing industrial regulations document:

Beas White Paper for regulated industries