"Real knowledge is to know the extent of one's ignorance."-Confucius

For many organizations, complying with complex regulatory and quality controls is always a challenge. They do not recognize the criticality of creating and approving a development report and updating it regularly throughout the manufacturing phases. Such things as failure to comply, employee error, accidents, inadequate system maintenance, even poor attitude, can result in fines, equipment malfunction, repetitive programs and retraining, all of it adding up to staggering costs.

Without a well documented development history, manufacturing changes may be unsupported during review or inspection, leading to rejection. Proactsys is well versed in establishing these quality and compliance systems that identify critical milestones throughout development

5.1 Requirement Analysis
Requirement Analysis is a pre-determined partial review of a company's current quality management system to determine what would be required to bring the company into compliance with the applicable standard(s) (e.g. ISO 9001/ISO 13485). This Analysis reviews the present policies, procedures, staffing, level of expertise, products being made and complexities of the operations. When we do the analysis, we will be cognizant of other compliance requirements (e.g. GMP, GCP) and we can adjust the Analysis to ensure all standards/regulations are met. It is always advisable to have a GAP Analysis performed prior to any implementation of a quality system to assure that the implementation can be fairly determined within a realistic timeframe.

5.2 Quality & Regulatory Management Systems
Proactsys quality systems are designed to comply with the fundamental requirements of international quality system standard. Proactsys helps our clients meet regulatory compliance efforts by developing and designing process and procedures that meet the goals of the regulation and at the same time developing the required documentation and training strategies required for implementation, auditing and tracking.  Frequently the regulatory compliance processes are tied into the organization overall quality management system. 

Regulatory, legislative and quality standard compliance can be costly and timely to all businesses and in many instances business do not have the resources or capability to meet or maintain their compliance obligations.

Proactsys offers the following services to all businesses;

• Write a quality management system to meet a clients specific legislative, regulatory or quality standard requirements

• Develop forms, documents, procedures and policies for clients to meet legislative, regulatory or quality standard

• Conduct internal auditing requirements for clients as required by legislative, regulatory or quality standard requirements

• Develop testing programs to meet client internal audit requirements

• Conduct business or organizational reviews for clients to provide independent analysis of the effectiveness of existing business processes

• Provide evidence for external registration bodies on the effectiveness of a clients management system in order to maintain current certification or qualification requirements

Proactsys ‘pay as required’ payment solutions enables businesses to meet their compliance obligations by outsourcing costly non operational activities that bogs down staff and resources instead of enabling the business to focus on producing and selling their products and services.