Six Sigma Solutions offer a range of services to assist with compliance and validation. Our experienced team is well-versed in regulatory requirements and can provide guidance and support to ensure your organization meets all necessary standards.

Whether it's creating and implementing compliance programs, conducting audits and assessments, or providing training and education, we have the expertise to help you navigate the complex world of compliance.

Our validation services include the validation of systems, processes, and equipment to ensure they are operating effectively and in accordance with industry standards. With our comprehensive approach and attention to detail, you can trust us to deliver reliable and efficient solutions to your compliance and validation needs.

Experience a seamless journey towards regulatory excellence!

Our Services

Project Management

Six Sigma Solutions services encompass the entire software development life cycle and project management. We provide comprehensive solutions, starting from the initial analysis and requirement gathering phase, followed by the design and development stages. Our team of skilled professionals ensures that the software is thoroughly tested and debugged before deployment.

We also offer project management services, ensuring that every aspect of the project is meticulously planned, monitored, and controlled to achieve successful outcomes. Six Sigma Solutions expertise in software development and project management allows us to deliver high-quality solutions that are tailored to meet the unique requirements of our clients.

Additionally, computer project management services provide risk management, quality control, and change management to address any issues or changes that may arise during the project. With our services, businesses can streamline their processes, enhance productivity, and achieve their desired goals effectively and efficiently.

• Complete Project Management

• Project Plan, Charter & Scheduling

• Aligning & Mapping the Lifecycles

• Resource Allocation & Intelligence

• Project Assessment

• Requirements Development (URS, BRS, FRS)

• Specification Development (DC, CS, DA, TS)

• Data Migration & System Transitions

• Commissioning & Decommissioning

• CMMS Support

Computer Systems Validation (CSV)

CSV is of utmost importance in today's technology-driven world. Six Sigma Solutions can assist in ensuring that computerized systems used in regulated industries are functioning reliably and consistently confirming the integrity, accuracy, and security of data generated by these systems.

Our team can helps to minimize risks and errors, ensuring compliance with regulatory requirements and industry standards. With us validating computer systems, your organizations can confidently rely on the information generated by these systems for critical decision-making processes.

Six Sigma Solutions offer range of activities, including documentation, risk assessment, system configuration, and validation testing. These services are tailored to meet the specific needs of each organization, helping them in achieving compliance and maintaining data integrity.

By engaging in with our CSV services, clients can mitigate the risks associated with computer system failures, data breaches, and regulatory non-compliance. With the ever-increasing reliance on computer systems, the importance of robust CSV services cannot be overstated.

Quality & Compliance

Six Sigma Solutions specializes in providing services related to quality management, regulatory compliance, and 21CFR Part 11. We understand the importance of maintaining high-quality standards in the products and services offered by your organizations. we can assist in implementing quality management systems that not only meet regulatory requirements of your business area but also enhance overall operational efficiency for your sustainable growth.

Our team of experts offers comprehensive solutions tailored to each client's unique needs, including documentation review, process validation, and training programs. Six Sigma Solutions team of experts is well-versed in the regulations and guidelines set forth by regulatory bodies. We offer comprehensive solutions to help businesses ensure compliance with these regulations. With our expertise in 21CFR Part 11, we help businesses establish and maintain electronic records and signatures that are compliant with the FDA's regulations. We strive to help our clients navigate the complex landscape of pharmaceutical regulations and maintain the highest level of quality in their products and processes.

Whether you need assistance in implementing compliant systems or conducting internal audits, our experienced professionals are here to support you every step of the way. Let us be your trusted partner in achieving pharmaceutical excellence.

• Corrective & Preventive Actions (CAPA)

• Deviation & Non-Conformance Process

• Change Control Process & Services

• Standard Operating Procedures (SOP)

• Work Instructions & User Manuals

• 21CFR Part 11 & Other Regulations Support

• Audit Preparations, Checks & Responses

• Effectiveness Checks

• Quality Oversight

• Trainings & Seminars