Quality Assurance

Komply can help your business with process improvements, linking quality attributes to process controls, training, and establishing quality management systems (QMS).

How does your business benefit?

Quality Assurance (QA) is a proactive process-oriented strategy used throughout the product life cycle or by service providers. Functional QA demonstrates that quality requirements are fulfilled and sustainable.

Effective quality standards, management systems, and training are at the core of every successful operation. Sponsors, manufacturers, laboratories, suppliers, distributors, warehousing, and logistics operations can all see the lasting benefits of QA.

Benefits to your business can include:

Compliance with law, regulations, and industry standards,
Increasing organisational efficiency and resultant cost-saving,
Mitigating risk, and
Improving products and services.

With over 30 years’ industry and consulting experience, Komply can help you:

Define quality and regulatory requirements,
Create or improve quality standards,
Design, develop, implement, and improve quality systems,
Marry quality attributes with process controls,
Reduce regulatory burden, and
Train personnel.

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Industries we work with

Pharmaceutical

Active Pharmaceutical Ingredients (API)
Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables), steriles, and freeze-dried
Prescription medicines, Over-the-Counter (OTC), complementary & herbals
Biologicals
Blood & Blood Components
Drug and device combinations

Veterinary Medicine

Active Pharmaceutical Ingredients (API)
Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables, drenches, dips), steriles, and freeze-dried
Biologicals

Food and Beverage

Dairy
Processed & ultra-processed foods
Allergen management & control
HACCP

Logistics

Transportation
Warehousing
Distribution

In Vitro Diagnostic Device (IVD)

Class I, II, III, IV (TGA – Australia)
Class I, II, III (US FDA)
ELISA
Diagnostic disease screening
Lateral flow
Immune diagnostic
Chip/capillary
Capture systems
Injectables
Point of Care (POC) or self-testing

Medical Device

Classes I, Is, Im, IIa, IIb, and III (TGA - Australia)
Classes I, II, and III (US FDA)
Lowest, low, moderate, and high risk (TGA – Australia)
Simple & complex
Disinfectants & sterilants

Cosmetics and Sunscreen

Primary sunscreens
Secondary sunscreens
Listed therapeutics
Registered therapeutics

Other

Testing laboratories
Building and construction (laboratories & cleanrooms)

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Standards applied in our work

PIC/S Guide to Good Manufacturing Practice for Medicinal Products
US Code of Federal Regulations
ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes
ISO 14971:2019 – Medical devices – Application of risk management to medical devices
ISO 9000 Standards Series (including ISO 9001 – Quality management systems – Requirements)
Veterinary GMP codes
HACCP, Food Standards Code, and Food Safety Systems (FSSC 22000)

What sets Komply apart?

Leveraging over 30 years’ experience in leading national and multinational biotechnology, contract manufacturing, and consulting organisations, we provide reliable and personalised service.

We believe consulting should be as educative as it is troubleshooting. We transfer knowledge, skills, and experience from consultant to client, and inspire organisational self-sufficiency. You will leave knowing you can tackle challenges without significant external help.

Our tailored, flexible, and client-centric approach means you can rest easy knowing your goals will always be met.

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