Support

We manage the three typical project management concerns, of Time, Cost, Quality in accordance with effective Project/Quality Planning based on our experience and proven industry guidelines. By working closely with senior management and project teams to ensure required deliverables are both planned and managed effectively, we ensure required quality standards are built in and maintained throughout.

We assist in clarification of requirements for both customers and vendors and help to ensure that required documentation to appropriate standards are in place and are understood in order to ensure the procurement process works in favor of all concerned.

We offer a wide External Audits, covering the review status of new or existing suppliers and their adherence to recognized good quality practices. In addition, we also specialize in conducting all aspects of Internal Audits that can range from retrospective audits of existing buildings, departments, sites, systems, processes or on-going projects covering single or multi-site locations. By providing effective health status checks to senior management, we can help save both time and money.

Our consultants help companies and organizations plan the validation/quality strategy of a system or piece of equipment, covering roles and responsibilities, deliverables, and policies and procedures that must be covered. Planning, and more importantly effective planning, is the key to success.

Our consultants assist in creation and management of documentation from establishing effective documentation standards, to ensuring conformance to them, including formal reviews and change management and approval. By adopting a policy of continuous improvement, our consultants help companies establish a baseline and solid foundation that can be built on.

Our consultants assist in all areas of testing throughout the lifecycle, including guidance procedures, policies and in particular procedures covering specifications, protocols and their planning and execution. Management and support of these activities as well as managing the expectations of both users and senior management are challenges, which our consultants deal with on a regular basis.

Documentation, Hardware and Software are key areas of Configuration Management that must be dealt with. Our consultants provide effective advice and support by revising or providing policies and procedures that can demonstrate compliance to regulatory needs as well as effective tracking of versions and traceability.

Assessments of equipment and systems for conformance to cGxP regulations continues to trouble many companies, in particular with systems containing electronic records and signatures as defined in US FDA 21 CFR Part 11. By utilizing our regulatory database cGARD (current Global Automated Regulatory Database) our consultants can help to identify particular areas of concern. By active involvement in many industry led initiatives, our consultants are at the forefront of the very latest information available.

By adopting an industry and regulatory recognized process of a risk based approach, our consultants help to ensure that risks are identified, documented, prioritized and mitigated through a considered process.

Effective planning and documentation by our consultants ensure that data being moved from one system to another, be this as part of a system upgrade or retirement, is conducted in an effective and compliant manner.

Review of individual systems or complete departments and sites for current compliance to GxP regulations ensures that modifications, changes, status of backups, etc. are all under control and that the current status of the system is validated and therefore compliant. Often too many changes can mean that the system is not under effective control and our consultants identify these areas and help to implement corrective actions in order to resolve issues in a cost effective and pragmatic manner.

Our consultants are well trained to review Gaps or areas of non-compliance such as aspects of system implementation, on-going maintenance and support, in particular the lack of company policies and\or procedures. With respect to life cycle implementation, the review of traceability from User Requirements to Functional Requirements, and traceability and analysis of gaps between the Functional Specification and the Test Specifications are key and our consultants assist in providing Traceability Matrix and Risk Assessment documents which can support identified gaps so that appropriate actions can be taken. By working with staff and management, our consultants can really make the difference and help a company focus.