Quality and regulatory compliance

Program planning
Quality and regulatory compliance is one of the major functions of Research and Development Department. The department team is focused and committed to providing quality auditing and consulting services. The goal is to provide quality consulting and generate recommendations in order to ensure compliance with the regulations, laws, policies and procedures enforced by the government regulatory agencies, profile organizations and other regulatory authorities. This function assumes close cooperation between R&D team and Quality Assurance Department. In the regulatory affairs, the team plans and develops Programme for regulatory work and quality compliance. Programme focuses on preparing of pre-approval inspections as well as providing problem solving and solution of compliance and enforcement issues. Examples of Programme items could be:

• Developing and submitting research documentation for new products
• Working closely with regulatory authorities to ensure that regulatory angles are covered in R&D projects
• Obtaining guidance documentation from regulatory agencies
• Monitoring analysis articles of related government documents, regulations and court cases
• Conducting pre-approval inspection and compliance assessments

To organize team collaboration and close teamwork R&D Department can useVIP Task Manager. The software allows to plan tasks and activities for Programme development. Each task can be set with due date and assigned to employee. Once a task is started, VIP Task Managershows time left for the task in the column “Time Left” so employee can plan his activities more efficiently.

Keeping track of compliance
R&D department management with executive responsibility needs to keep track of the regulatory affairs, quality assurance, and compliance functions. This means taking control over resources and their performance in Programme. To provide high quality, the management should be responsible for attaining business quality and compliance success. The management responsibilities can be summarized by the following tasks:

• Becoming knowledgeable about applicable regulations and requirements
• Taking responsibility for compliance and holding the entire organization responsible
• Setting and monitoring effectiveness metrics
• Managing changes and setting task priorities based upon risk
• Allocating or reallocating resources

By using VIP Task Manager, the team leader can track each task related to Programme and be knowledgeable about current progress. The software allows management to be fully engaged in the transparent progress of Programme. The team leader can monitor resource assignments and track current activities in real time. Email notification messages system in VIP Task Manager allows to keep track of Program progress being away from the office. The team leader can share his management responsibilities by assigning supervisors in Watch List.

Programme reporting

Regulatory and quality compliance needs to be reported to view achieved results in Programme development. Detailed report will allow to analyse each step made in the development and ensure that compliance is aligned with the organization’s business goals and risk management strategies. Ultimately, the goal of regulatory and quality compliance report is ensuring that the compliance as well as the letter of the law is embraced in every corner of the organization. By using VIP Task Manager, the team leader can build task report on Programme development. The report may include complete information on Programme development project such as “History”, “Assignments”, “Comments”, and other. The team leader can create the report in HTML or text format. In VIP Task Manager, there is also option to export tasks of the project into Excel sheet so that such a report will be convenient for detailed analysis of the tasks.