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Validation:

  • Process Validation

  • Design Validation

  • Equipment Validation

  • Cleaning Validation

  • Computer Systems Validation

  • Packaging Validation

  • Test Method Validation

 

Compliance Standards:

  • 21 CFR Part 11 - Electronic Records; Electronic Signatures

  • 21 CFR Part 58 - Good Laboratory Practice For Nonclinical Laboratory Studies

  • 21 CFR Part 210 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General

  • 21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals

  • 21 CFR Part 820 - Quality System Regulations

 

 

Project Management:

 

SIX-SIGMA AND LEAN MANUFACTURING

Lean Six Sigma is a methodology that relies on a collaborative team effort to improve performance by systematically removing waste; combining lean manufacturing/lean enterprise and Six Sigma to eliminate the eight kinds of waste (Muda): Time, Inventory, Motion, Waiting, Overproduction, Over-processing, Defects, and Skills

Six Sigma seeks to improve the quality of the output of a process by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes. It uses a set of quality management methods, mainly empirical, statistical methods, and creates a special infrastructure of people within the organization, who are experts in these methods. Each Six Sigma project carried out within an organization follows a defined sequence of steps and has specific value targets, for example: reduce process cycle time, reduce pollution, reduce costs, increase customer satisfaction, and increase profits.

 

STAGE-GATE

A Stage-gate process is a project management technique in which an initiative or project (e.g., new product development, process improvement, business change) is divided into stages or phases, separated by gates. It is is a conceptual and operational roadmap for moving a new project from idea to launch – a blueprint for managing the new-product process to improve effectiveness and efficiency. Stage services provided:

  1. Scoping

  2. Build business case

  3. Development

  4. Testing and validation

  5. Launch

Gates provide various points during the process where an assessment of the quality of an idea is undertaken. It includes three main issues:

  • Quality of execution: Checks whether the previous step is executed in a quality fashion.

  • Business rationale: Does the project continue to look like an attractive idea from an economic and business perspective.

  • Action plan: The proposed action plan and the requested resources reasonable and sound.

Apeiro Group can provide services to identify and analyze all the stages and gate progress in any process.

 

Risk Assessment and Management:

It is imperative that Medical device companies MUST have established risk management processes that comply with ISO 14971, regardless of origination or target geographical region for the medical devices.  ISO 14971 is accepted as the risk management standard for the medical device industry by every International regulatory agency that exists.

Apeiro Group has experienced engineers who can perform all parts of the Risk Management Process as defined in ISO 14971:2007, such as:

  • Risk Analysis - Systematic use of available information to identify hazards and to estimate the risk using PFMEA and DFMEA.

  • Risk Evaluation - Deciding which risks are acceptable and which are unacceptable.

  • Risk Control - Reduce and mitigate unacceptable risks.

  • Residual Risk Evaluation - Re-evaluation of the resulting risks after applying Risk Control

  • Risk / Benefit Analysis - Comparison of the medical benefits of the device and the residual risks.

  • Evaluation of Overall Residual Risk Acceptability - Evaluation of the complete medical device and the overall residual risk acceptability.

  • Risk Management Report - Proper documentation of the Risk Assessment and Management process, and report generation

  • Production & Post-Production - Periodic review and re-evaluation of the product after it has exited the development stage

 

Quality Management System:

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is expressed as the organizational structure, policies, procedures, processes, and resources needed to implement quality management.

  • ISO 13485 2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes

  • CAPA - Corrective and Preventive Action

  • The 8D (Eight Disciplines) problem-solving process

 

 

Information Technology Services:

 

COMPUTER SYSTEMS VALIDATION

Computer system validation or CSV is the process of documenting that a computer system meets the defined regulatory requirements. Computer Systems Validation ensures accuracy, reliability, consistent intended performance, and provides the ability to discern invalid or altered records, which are critical requirements of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

 

BIG DATA AND DATA ANALYTICS SERVICES

Big data analytics is the process of examining large data sets containing a variety of data types -- i.e., big data -- to uncover hidden patterns, unknown correlations, market trends, customer preferences and other useful business information. This help businesses with:

  • Cost reduction.

  • Faster, better decision making.

  • Developing new products and services.

 

WEB AND ENTERPRISE APPLICATION DEVELOPMENT AND MAINTENANCE

Services provided include:

  • Enterprise Application Development and Maintenance

  • Mobile Application Development and Maintenance

  • SaaS - Software as a Service

  • Service Oriented Architecture Development and Maintenance

  • Software Testing

 

INFORMATION SECURITY

Information or IT Security is the process of implementing measures and systems designed to securely protect and safeguard information utilizing various forms of technology developed to create, store, use and exchange such information against any unauthorized access, misuse, malfunction, modification, destruction, or improper disclosure, thereby preserving the value, confidentiality, integrity, availability, intended use and its ability to perform their permitted critical functions. Apeiro IT Security Services include:

  • Security and Risk Consulting

  • Security Architecture and infrastructure design

  • Threat Intelligence

  • Incident Response

 

CLOUD SERVICES

Salesforce, Amazon Cloud Services, Google Cloud

 

DATABASE MANAGEMENT AND SQL SERVICES

The DBA professionals at Apeiro Group have deep technical and process expertise that allows them to help improve your current database management operations and bring down your total cost of ownership. Our DBAs have architected, configured, and managed complex ERP integrations, rollouts, database migrations, and upgrades for some of the largest companies in the world.
Our services support a wide range of technologies including Oracle, Oracle Agile, Oracle E-Business Stack, SAP DBA, SQL Server, Sybase, DB2, MySQL, and Database Appliances.