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Life Sciences

Quality, biosafety and evidence governance for laboratories and regulated innovation.
Laboratory scientist working with analytical equipment
COHSEW field perspectivePhoto via Unsplash

Objective

What this area means for safer, healthier and more responsible operations.

Life-science operations require controls proportionate to biological, chemical, physical, data and product risks. COHSEW supports risk assessment, biosafety, laboratory quality, supplier control, validation, training and secure handling of scientific information.

COHSEW principleUse competent, risk-based assurance to prevent harm, verify control and support continual improvement.

Priority controls

Where organisations should focus.

Priorities must be adapted to the organisation, activity, location, affected people and applicable legal requirements.

01

Biosafety and biosecurity risk assessment

Define ownership, expected evidence, monitoring and escalation before relying on this control.

02

Laboratory quality and method suitability

Define ownership, expected evidence, monitoring and escalation before relying on this control.

03

Sample, material and data integrity

Define ownership, expected evidence, monitoring and escalation before relying on this control.

04

Change control, competence and incident learning

Define ownership, expected evidence, monitoring and escalation before relying on this control.

How COHSEW supports you

From risk question to measurable assurance.

Our specialists help organisations select proportionate methods, preserve independence and turn technical evidence into action.

  1. 01
    Define intended use and critical quality attributes

    Agree the scope, accountable owner, evidence and success measures, then review effectiveness over time.

  2. 02
    Apply risk-based containment and control measures

    Agree the scope, accountable owner, evidence and success measures, then review effectiveness over time.

  3. 03
    Maintain traceability from sample to reported result

    Agree the scope, accountable owner, evidence and success measures, then review effectiveness over time.

Authoritative guidance

Continue with the primary sources.

These external resources informed this page. Always confirm current national law, regulator guidance and contractual requirements for your location.

Information on this page supports awareness and programme design. It is not legal, medical or regulatory advice, does not reproduce the full text of any standard and does not replace competent assessment of your specific circumstances.

Need a programme for Life Sciences?

Define the right scope with a COHSEW specialist.

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