Governance, Risk and Compliance Blog

Pharmaceutical Development Company Nanopharm Opt for EQMS by Qualsys

Posted by Emily Hill on Thu, Aug 03, 2017

Qualsys are delighted to welcome pharmaceutical development company Nanopharm as a new EQMS customer. Nanopharm will be implementing a full suite of EQMS modules to support scalable quality and compliance management systems. 

Nanopharm are the leading provider of tailored analytical and product development of orally inhaled and nasal drug products (OINDPS). They'll be using EQMS to manage all their documentation, audits, corrective and preventive actions.

Susanne Durie, Head of Quality at Nanopharm, said the team are excited to see how the system will grow within their organisation. "We’re looking forward to exploring the software and finding out how we can make the most of it." 

EQMS by Qualsys is the preferred solution for many pharmaceutical development companies, as the software helps connect data, processes, business systems, assets and people in a central, unified solution. The system helps organisations to meet standards such as ISO 17025, ISO 13485 and ISO 14971, and robust controls required for MHRA and FDA.

Welcome cake sent to Nanopharm


Alex Swan, New Business Manager at Qualsys, has seen many lifescience and medical device manufacturers discover more hidden value in EQMS during the implementation process.

"The Qualsys implementation team take a best-practice approach to implementing EQMS," Alex said. "This is the best opportunity most quality professionals get to take a deep look at their processes and, with our help, make them more streamlined, efficient and compliant.

"After the implementation process, not only do our customers see considerable cost savings, they find their organisations are more agile and faster to adapt to change. We help other businesses to become fitter, faster and stronger.

EQMS KPI Dashboard

For more information about using EQMS for pharmaceutical, medical device and lifescience quality management systems, download our customer case studies here. 

Download EQMS Case Study Booklet

Tags: FDA, ISO 13485, ISO 17025, MHRA

ISO 17025 Explained – Management and Technical Requirements

Posted by Marc Gardner on Thu, Aug 03, 2017

ISO 17025 is the international standard for testing and calibration laboratories. It's a set of requirements those laboratories use to show that they operate a quality management system and that they're technically competent to do the work that they do.

The standard is set out in five clauses:

  1.    Scope
  2.    Normative references
  3.    Terms and definitions
  4.    Management requirements
  5.    Technical requirements

(However, as ISO 17025 is currently being revised – it's at the approval stage at the time of writing – the format of the standard will be changing to adopt the Annex SL structure. Read more about Annex SL here.)

The scope means a clear statement of everything the lab does for which it wants to be accredited. A testing lab will set out its specific methods for conducting its tests. A calibration lab will list the specific measurements and associated uncertainty it uses in its calibration work. Defining the scope means the lab can identify suitably skilled staff and give clients confidence in its tests and measurements.

The two main sections of ISO 17025 are clauses 4 and 5, which cover the two types of requirements.

Management requirements (clause 4)

Clause

What it covers

4.1 – Organisation

Legal status

Facilities (permanent, temporary or mobile)

Responsibilities of key staff

How confidential information is handled

Management – structure; deputies; appointment of quality manager; supervision of staff

4.2 – Management system

Establishing, implementing and maintaining a QMS appropriate to the scope

Issuing a quality manual and quality policy

Commitment to professional practice and complying with the standard

Staff familiarising themselves with the QMS

Responsibility and authority of quality manager

4.3 – Document control

Procedures for:

  • Controlling all documents (internal and external) relating to the QMS – regulations, normative reference documents, drawings, specifications, instructions, manuals etc.
  • Approving and issuing documents (including maintaining a master list)
  • Changing/correcting documents
4.4 – Reviewing requests, tenders and contracts Policy and procedure for reviewing requests, tenders and contracts
4.5 – Subcontracting tests and calibrations Policy and procedure for subcontracting testing and calibration work
4.6 – Purchasing services and supplies Policy and procedure for choosing and buying services and supplies that, when used, may affect the quality of tests and/or calibration
4.7 – Service to the client

Good communication and co-operation with clients

Protecting clients' confidentiality

4.8 – Complaints Policy and procedure for recording and resolving complaints
4.9 – Controlling non-conforming testing and/or calibration work Policy and procedure for dealing with non-conforming work or problems with the QMS, testing and/or calibration
4.10 – Improvement Continually improving the QMS by using the quality policy, auditing, data analysis, corrective and preventive action and management review
4.11 – Corrective action Policy and procedure for taking corrective action when non-conforming work or faults in the QMS or technical operations have been identified
4.12 – Preventive action Policy and procedure for identifying and taking preventive action
4.13 – Controlling records Procedure for controlling records (identification, collection, indexing, access, filling, storage, maintenance and disposal of quality and technical records)
4.14 – Internal audits Policy and procedure for conducting internal audits and implementing findings
4.15 – Management reviews Procedure for management reviews of policies and procedures, audit findings, corrective and preventive action, customer feedback etc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Technical requirements


Clause

What it covers

5.1 – General

Factors affecting results of testing or calibration

5.2 – Personnel

Ensuring all laboratory staff are properly skilled and qualified

5.3 – Accommodation and environmental conditions

Policy and procedure on monitoring, controlling and recording accommodation and environmental conditions so testing and calibration is done correctly

5.4 – Test and calibration methods and method validation Policy and procedure for choosing methods of testing and calibration (which covers sampling, transport, storage, uncertainty, control of data etc.)
5.5 – Equipment Policy and procedure for ensuring equipment used for testing and/or calibration is available, suitable and properly maintained
5.6 – Measurement traceability Procedure for choosing, using, calibrating, checking and maintaining measurement standards, reference materials used as measurement standards, and equipment used for testing and calibration
5.7 – Sampling

Plan and procedure for sampling

5.8 – Handling test and calibration items Policy and procedure for recording and resolving complaints
5.9 – Assuring the quality of test and calibration results Procedure for monitoring the validity of testing and calibration
5.10 – Reporting results Ensuring results of testing and calibration are reported clearly and objectively

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Using EQMS for ISO 17025 

Many medical device manufacturers and life science research facilities use EQMS to meet ISO 17025. EQMS helps integrate data, processes, business systems, assets and people in an extended enterprise. The integrated modules enable you to easily maintain all procedures, sampling records and audits in a centralised, unified system. 

What you should do now

Download our case study booklet to learn how global brands like Diageo, Sodexo and BT and hundreds of SMEs across the UK use EQMS to transform the role of quality and compliance in their organisation.

Download EQMS Case Study Booklet

Tags: ISO 17025