MES Functions

Compliance and Quality

Details
Category: Quality Assurance

EazyWorks the Solution for Compliance

Manufacturing Execution System (MES)

EazyWorks EZ-MES is a customizable, flexible MES system with scalability for any business needs both present and future. EZ-MES supports your businesses manufacturing processes, to optimize operations, maintain product standards and achieve a competitive advantage with the added benefit of compliance support e.g. ISO and FDA 21 CFR Part 11 requirements.

Services and Product Types Supported by EZ-MES

  • Food and beverage
  • Semiconductor
  • Automotive
  • Optics
  • Machined products
  • Electronics
  • Testing and product verification
  • Medical devices
  • Biotech
  • Pharmaceuticals
  • Nutriceuticals

Solution

EazyWorks EZ-MES system is designed for all businesses in the manufacturing or testing service industry. EZ-MES functionality and features have been designed to meet the requirements defined by the US Food and Drug Administration (FDA), ISO qualification or validation and other business standards or regulatory agencies.

The compliance solution is integrated in EZ-MES as standard to provide good manufacturing practice (GMP), basic required functionality such as electronic signatures, system security, support for open and closed systems, certification etc. EZ-MES also provides a comprehensive set of support documentation and facilitates the integration of custom qualification documentation as defined by the end user.

EazyWorks is committed to the introduction of extended capabilities in EZ-MES as the requirements of industry changes and are compelled to be the best in its class solution for regulated environment and compliancy.

The following features have been integrated as standard in EZ-MES:

  • Time stamps on all records linked to users
  • Adherence to written policies
  • Security/Authority checks
  • Record protection
  • Data encoding
  • Device checks
  • Electronic signature
  • System documentation control
  • Intuitive user friendly configuration control
  • Traceability of unauthorized logon attempts
  • Full traceability and genealogy for all products
  • Electronic and human readable records generation
  • Accuracy, reliability, consistent performance, traceability of invalid or modified records
  • Enforcement of access levels linked to education , training  and experience of individuals

All features in the core functionality of EZ-MES are mandated by the FDA and other agencies. EZ-MES has been developed to optimize company manufacturing and help businesses achieve compliance and operate consistently across the whole system implementation.

Businesses are required to be much more careful in the way they operate and compliancy is fast becoming a mandatory need across all industry sectors. EZ-MES provides a smooth compliance route in a system that’s easily configured to support the requirements for every industry type e.g. High Tech, Pharmaceutical, Chemical, Food and Beverage etc.

Definitions

FDA - Food and Drug Administration: a federal agency responsible for monitoring trading and safety standards in the food and drug industries.

GMP - Practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices.

21 CFR Part 11 - Code of Federal Regulations dealing with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Qualification – The process of qualifying if an entity is capable of achieving specific pre-determined requirements. ISO 9000

Validation – Establishing documented evidence to provide a high level of assurance that a specified process will consistently manufacture a product that meets its predetermined specifications and quality attributes.

Certification – Certification implemented by EazyWorks helps ensure that every customer is properly trained and capable of configuring the system to meet their specific regulatory requirements.