We have significant experience in providing compliance consultation in the life sciences industry. We understand the regulations from US, Europe, Japan and other international regulations / guidelines to help regulated companies achieve full compliance.
One important challenge faced by the industry is the huge effort and money spent on validation. We believe in taking a lean approach and catering to specific needs. We adopt the Risk-based methodology to identify the right package and thereby save time and money.
We act as an independent validation partner for several top pharmas / CROs across the globe and the compliance team has audited several regulated companies.
We have an independent Quality Assurance team that enables us to ensure compliance within the organization. We also offer quality assurance as a service to our customers. We have
The team here has professionals who are certified in Software Quality analysis and Six Sigma Green Belt. We understand and implement ISO 9001:2008 framework, PDCA and apply this knowledge on the organization's processes and best practices for institutionalization.
We provide consultation on developing and optimizing your Quality Management System (SOPs, Guidelines, and Work Instructions) that should be compliant to regulatory and international standards / frameworks like ISO (SOPs, Guidelines, and Work Instructions) and robust enough to face FDA Audits.
We help organizations qualify their third party vendors to ensure compliance through a robust auditing mechanism.
Our Auditors are well versed in local, national and international standards / regulations. We are committed to performing a thorough assessment and providing insightful recommendations, combined with expedited audit reports.
Audits performed on your third party vendors to assess the adequacy of Quality systems, staff training programs etc.
Ongoing periodic review that focuses on continued compliance with standards and regulations.
Milestone based audits depending on the requirement of a product / study.
We understand the criticality and integrity of data in the life sciences industry. We leverage solutions and testing frameworks, to ensure that computerized systems are fit for intended use and are compliant with applicable regulations.
We have collaborated, as validation partners / consultants, with product vendors and/or sponsors (who buy COTS products) and have offered validation services through implementation, operation and sustenance phases.
Our customers gain assurance and confidence that their systems have been adequately reviewed and qualified to face any audit.
Our validation services span across the following areas,
Validate software deployed in the life sciences space for new releases, upgrades, integrations etc.
Classify, validate / verify, perform compliance assessments for SaMDs and support in regulatory filing.
Classify and qualify Medical Applications developed for Mobile devices operating in different platforms, and assist in regulatory filing.
Qualify and Validate Analytical instruments and instrument integrations with laboratory systems used in the GxP environment.
Automate the test execution process by developing test cases using automation tools for computer systems.
We believe in the importance of Risk-based validation and subscribe to the GAMP 5 approach of performing the optimal-level of validation, by cutting down on unnecessary cost, effort and documentation.
The below aspects are considered to identify the strategy to achieve compliance and to ensure fitness for purpose.
We understand the importance of business processes supported by a computer system and the impact of regulations on it, to effectively assess the risks posed by the computer system and its components.
Risk assessment is performed at the system / requirement / functionality level. Based on the category of the computer system and the risks involved, the validation package to be created is identified. The level of engineering principles and controls implemented during the development of a computer system is also considered to decide on the level of validation required on the system.
Our validation services span a variety of software / platforms in the life sciences space and for new releases, minor updates, upgrades, integrations etc. We have well-defined in-house processes in place and understand the need to adapt with customer specific processes if required.
End to End Validation Support
Our Validation deliverables include,
Made to order services
In addition to the above services, we also
Our expertise in assessing compliance with respect to these regulations has helped in facilitating product vendors meet regulatory standards and sponsors in establishing the required setup for a GxP environment.
Our consultants are trained in regulations such as EU Annex 11 & 15, 21 CFR Part 820, 11 and 58, Japanese ERES, HIPAA, PIPEDA. The regulatory requirements can be implemented as technical controls within the system and as process controls within the organization.
We assess the system functionalities and documentation as required by the regulations, and share a gap analysis report. We go one step ahead and provide support to address the gaps by proposing and implementing the actions required to achieve compliance.
We have Regulatory and Compliance Assessment Checklist to accelerate the assessment process - Part 11 / EU Annex 11/ HIPAA Assessment Suite.