Quality Standards & Regulations

Having a recognised management standard improves efficiency, reduces costs and provides higher level of customer service.

Quality Standards and Regulations

CloudEQMS, SMARTForm Builder and SMARTWorkflows have been developed to exceed the requirements of many quality standards and regulations.

 

ISO 9001:2015 Quality ManagementISO 9001

  • Manage and control company wide documentation consistently in line with the ISO9001 standard.
  • Provides full history and audit trail, it records every action – noting exactly who did what and when.
  • Set varied permission levels, CloudEQMS only allows users to see the correct up-to-date version of a document, eliminating error.
  • It highlights non-conformance to the standard

ISO/IEC 27001 Information Security ISO 27001 Information Security

  • Automate tasks such as controlled document approval and issue.
  • Set dedicated permission levels and utilise the audit management tool to drive ISO 27001 workflows throughout the organisation whilst ensuring company-wide compliance.
  • Promotes best practice on protecting the confidentiality, integrity and availability of company wide information.

ISO 14000 Environmental Management ISO 14000 Environmental Management

  • Allows you complete control of your environmental documentation.
  • It supports the training of the standard allows you to easily plan, manage and undertake your audits
  • Manage any incidence that is not in conformance with the standard
  • Manage all your associated equipment.
  • Assists in reducing the company’s environmental impact, specifying the requirements for an organisation’s environmental management system.

OHSAS 18001 Health & Safety OHSAS 18001 Health & Safety

Provides a framework to identify, control and reduce the risks associated with health and safety in your workplace.

 

 

Care Quality Commission (CQC) 

Care Quality Commission

  • Allows you to easily gather the evidence required to demonstrate compliance with CQC standards.
  • Automate tasks such as document issue and approval
  • Set dedicated staff permission levels; ensuring staff always view the right version of the right document
  • View full history and audit trails – every action undertaken is recorded noting exactly who did what and when.

Outcomes Focused Regulations (OFR) & SRA Code of Conduct for Solicitors in England and Wales

SRA Code of Conduct

The SRA Handbook 2011 introduces Outcomes Focused Regulation (OFR) of solicitors in England and Wales.

It replaces reactive, rule-based regulation with a more proportionate, flexible focus on adherence to high level principles and outcomes reflecting the interests of clients and the wider public interest.

OFR is introduced at a time of major market change and emphasises the importance of individual regulated firms having appropriate management systems and controls and targeted governance, monitoring and risk management arrangements to ensure compliance and achievement of client-focussed outcomes.

Learn more about OFR at the SRA website

FDA/CFR 21 Part 11 FDA/CFR

  • Automates your internal processes
  • Facilitates effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), and other quality and business processes.
  • Assist with implementing controls: including system validations, audit trails, and documentation for any software or system used.

 

Sarbanes-Oxley (SOX) SOX

  • Allows you to ensure adherence to company policies and procedures whilst lowering the costs associated with compliance with SOX.
  • Design, evaluate and improve internal controls whilst monitoring compliance processes at any level of detail.
  • When required, easily collate reports to provide evidence to external auditors.

GAMP / GxP Good Manufacturing Practice GAMP / GxP

Assists businesses operating within the Medical Device and Pharma industries who are compelled through the FDA and EMEA to instigate a formal validation process to ensure that all software is fit for purpose.

  • Risk Management
  • Change Control and Validation
  • Problem Resolution and Tracking
  • Electronic Data Archiving
  • Control and Compliance

ISO 15189:2012 Medical Laboratory accreditation ISO 15189

  • Can be used by medical laboratories in developing their quality management systems and assessing their own competence
  • It can also be used for confirming or recognising the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

ITAR Compliance ITAR

Provides a range of features to support your organisation’s ability to comply with International Traffic in Arms Regulations (ITAR) requirements

    • SSL encryption and access controls ensure only authorised users open and access documents.
    • Records all access to secured content and also has a simple management interface to allow viewing of existing user privileges and controls.
    • Comprehensive reporting is available to evidence ITAR compliance.
    • Provides a range of configurable controls to enable your business to reflect changes in ITAR compliance requirements.

 

Take the first step

Request a Demo, or for a no obligation chat call 0117 937 4712 or email enquire@p4p.uk.com