Life Sciences Solution

Meeting Governance, Risk & Compliance management requirements, by supporting regulatory, legislative and best practice demands.
Achieving continuous business improvement through consistency, efficiency and accountability.

In Life Sciences the ground rules are very clear. Comply with the wide-ranging legislative, regulatory and the best practice standards imposed on industry, or put the business at risk. At worst, operations or sales can be stalled until compliance is achieved. In some cases, the greatest harm comes from adverse publicity affecting sales, or the refusal of partners to do business with non-compliant organizations.

Compliance with regulations set by bodies such as the FDA, government requirements and industry standards generally requires transparency in how information is managed within the business. In many organizations the task of tracking the life cycle of information is a time-consuming, manual process. Others are already seeing the benefits of automation, particularly in the area of compliance with FDA 21 CFR Part 11.

At every level of your organization, directors and staff are likely to have concerns about how the business is managing compliance today.

Senior management challenges

• The risk of non-compliance is lost business and lost opportunities
• Determining return on investment for the cost of implementing improved compliance systems

Functional management challenges

• Time and resources devoted to compliance management rather than the core business
• Difficult-to-access silos of duplicated and disconnected information across the organization

User challenges

• Complexity of compliance procedures
• Distraction from primary role

IT challenges
Ensuring any new solution is proven, fully supported, scalable, easily integrated and flexible

The need for change
For many organizations audits are rapidly becoming a way of life, carried out by regulatory bodies, partners and customers. They can be disruptive at best, and can potentially find your business lacking in key controls. Automating compliance procedures brings consistency, efficiency and accountability to the process.

The most valuable solution will go beyond merely demonstrating compliance, by helping your organization achieve business improvements in all processes. The optimal solution will also integrate easily into your existing IT infrastructure, be fast and easy to implement, be easy to learn and use, and have the flexibility to evolve with your business.

Your total solution
Achiever Plus is a flexible, modular solution designed to help you to meet legislative, regulatory, and industry best-practice compliance requirements across the organization, including FDA 21CFR Part 11. Each module addresses key compliance issues.

Module	Supporting Life Sciences compliance
Document Management	Control of entire life cycle: creation, review, approval, publishing, email notification, change requests, archiving Integrates with MS Word, Excel, Visio, Powerpoint Capable of working with third party CTD/eCTD publishing tools Process mapping using Visio flow charts Preventing unintended use of incorrect documents Automated document protection and retention rules Enterprise-wide involvement in the change process
Audit and Corrective Action Management	Preparing and maintaining audit checklists for procedures, processes, departments etc Creating audit profiles for any area or process, detailing the frequency and responsibilities of the audit Creating and progressing audit reports, including electronic sign-off by the auditor and auditee Creating and managing non-conformances and corrective actions associated with audits
Issue Management	Enabling employees to report problems by raising issues, corrective and preventive actions Providing details on weaknesses and trends to enable corrective actions or programmes Ensuring issues are addressed within defined timescales with flexible escalation process
Meetings Management	Planning and tracking meetings relating to the running of the management system Tracking of action and automated escalation when overdue Flexibility to include other categories of meetings, i.e. projects Achieving transparency of management meetings and resulting actions
Competence and Training Records Management	Determining necessary competence for personnel Maintaining appropriate records of education, training, skills and experience, including the acknowledgement of training associated with management system updates
Contact Management Tracking	customer feedback and supplier problems Enabling customer satisfaction questionnaires Managing supplier approval, performance review and audit Logging communications with regulatory bodies which control relevant legislation Managing and tracking all general communication within defined organisations or projects
Equipment management	Control of equipment validation Logging all items of equipment held, together with basic asset information Planning and recording of periodic inspections
Management Reporting and Graphical Analysis	Trend analysis, i.e. corrective actions/complaints Instant visibility of skills/ training records

Benefits of Achiever Plus:
While helping you to control documents and processes more effectively, Achiever Plus also offers the opportunity to identify potential issues before they arise, enabling you to become proactive rather than reactive in dealing with compliance issues. By automating procedures, you can demonstrate compliance to auditors faster and more clearly, saving time and effort for all parties, and minimising disruption to your operations. Importantly, Achiever Plus provides a basis for you to reassess and redesign processes and procedures in line with your business objectives and to deliver a clear return on your investment.

Achiever Plus:

• Delivers consistency, efficiency and accountability
• Reduces administration through the use of automation
• Demonstrably satisfies legal requirements for due diligence
• Enables transparency across business data and processes
• Provides advanced controls for managers
• Has the flexibility to track requirements and changes in the business and evolve with them
• Can be implemented in just weeks, at low cost and low risk
• Software validation packs provided, including validation master plan, scripts, 21CFR Part11
• Compliance checklist and final validation report template