Pharmaceuticals and Life Sciences Pharmaceuticals and Life Sciences

With health and wellbeing directly at stake, Life Sciences is faced with unique Governance and Compliance pressures. Pharmaceuticals and Life Sciences companies require solutions which include a comprehensive suite of quality functionality to meet this complexity.  Sword Achiever has over twenty year experience in serving a range of companies across pharmaceuticals, medical devices, and blood and biologics.

Healthcare

At Sword Achiever, we understand the continued pressures that Healthcare faces to maximise achieved outcomes and patient safety while also meeting increasingly strict budgetary requirements.  It is our goal to help our customers achieve these objectives through the delivery of risk and compliance software solutions.

Highlights Include:

  • Fully managed services, safety alerts, CQC Essential Standards etc. uploaded and ready to use.
  • Flexible, fully configurable management level dashboards deliver actionable intelligence that helps guide accurate and ethical decision making.
  • On demand, real-time, interactive reporting provides drill down capabilities to view the macro and micro levels.
  • Simple to use web-based platform which integrates with existing solutions, using nothing more than a web browser on computers or mobile devices.
  • Fully configurable security profile.  Access to data is controlled by security permissions applied by client system administrators ensuring data is only viewed or edited by appropriate staff.
  • Configurable automatic alerts and escalations from the most simplistic (e.g. sending an alert through email, text, or pager); to advanced (e.g. linking with other systems to deliver alerts and actions such as PAS, SharePoint, etc.)
  • Fully managed hosted service or hosted within your own organisation – the choice is yours.
  • Comprehensive professional services to project manage the implementation and configuration.

Pharmaceuticals

With regulatory demands from national bodies such as the FDA and regulations, such as ISO 13485, 21 CFR Part 11, REACH and GxP, along with countless Standard Operating Procedures, the need for a trusted, easy to use Governance, Risk, and Compliance solution has never been greater.

From discovery to clinical trials, and on to patient delivery, deploying an integrated quality management system for the performance of covigilance activities by all stakeholders is more critical than ever.

Highlights Include:

  • Ensure 21 CFR Part 11 electronic signature requirements are met along each stage of the process every time a user alters documentation.
  • Ensure your numerous Standard Operating Procedures (SOP) can be managed and maintained in one system ensuring the right documents are used at the right time by the right people.
  • Identify potential issues before they arise, enabling you to become proactive rather than reactive in dealing with compliance issues.
  • Demonstrate compliance to auditors faster and more clearly, saving time and effort for all parties, and minimising disruption to your operations.

Blood Services

The quality and safety of the blood supply is of the utmost importance. Between donor quality, suitable blood testing, and adhering to strict FDA and AABB standards, the Blood Services industry must maintain strong quality and compliance.

Having a compliance platform in place that can adapt to the changing regulatory environment, while being flexible enough to match evolving business processes is key in the Blood Services industry.

Highlights Include:

  • Ensure 21 CFR Part 11 electronic signature requirements are met along each stage of the process every time a user alters documentation.
  • Ensure your numerous Standard Operating Procedures (SOP) can be managed and maintained in one system ensuring the right documents are used at the right time by the right people.
  • Ensure traceability of blood components from initial donor collection to transfusion or disposal.  Have a clear view of the current status from processed to tested and stored.
  • Demonstrate compliance to auditors faster and more clearly, saving time and effort for all parties, and minimising disruption to your operations.

Medical Devices

Success in the Medical Device industry requires adherence to numerous regulations - ISO 13485, ISO 14791, 21 CFR 820 and 21 CFR Part 11. Development, innovation, and distribution Rapid product development processes providing responsiveness to changing market demands are key to meeting the demands of this market.

Highlights Include:

  • Ensure 21 CFR Part 11 electronic signature requirements are met along each stage of the process every time a user alters documentation.
  • Manage and maintain your processes in one system ensuring the right documents are used at the right time by the right people, from suppliers to contract manufacturers.
  • Track your product life cycle from inception to customer feedback for improvement, innovation, and competitive advantage. 
  • Demonstrate compliance to auditors faster and more clearly, and get innovative products to market more quickly.
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