Life science quality
trends report 2025

We asked 2000 global life science quality professionals to share their lessons, headaches, working styles and plans with us in our fourth annual survey.

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What stood out…

26% still using paper

Over a quarter of life science quality professionals still rely on analog quality systems

Less investment = less maturity

Respondents using paper and spreadsheets reported lower operational and quality maturity, and a more difficult day-to-day

AI on the up?

57% already use AI in some capacity in their day-to-day work and 81% are interested in applying AI to quality work

Money where the mouth is?

Business leaders promote quality, but don't invest in it to the same degree — and budget not aligned with headcount

Time spent in the wrong places

Upkeep, admin and non-value-add tasks continue to occupy large chunks of the working day

New lifesaving products

Almost 15% of respondents are aiming to bring a new product to market this year — a key objective for 2025!

Quality & compliance targets for 2025

43% of medical device companies aim to achieve EU MDR or IVDR compliance in 2025. Over a third of pharma and biotech companies have no new plans.

Medical device

Therapeutics

*Quality Management Maturity

EU MDR/IVDR

43%​

FDA 21 CFR 820

43%​

ISO 13485

33%​

ISO 14971

28%​

ISO 27001

28%​

None

19%​

GMP

14%​

ISO 14155

9%​

ISO 9001

9%​

GCP

0%

Other

5%

None

36%​

GMP

32%​

ISO 9001

19%​

FDA QMM* Program

13%​

ICH Qx

7%​

ISO 17025

7%​

ISO 15189

5%

PIC/S

5%

GCP

4%

ISO 27001

0%

Other

11%

Impact of an eQMS

Going digital pays off

Did implementing an eQMS have a beneficial effect on your day-to-day work?

3%

No

97%

Yes

Did implementing an eQMS have a beneficial effect on your product and process quality?

18%

No

82%

Yes

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Stats & metrics

Most common KPIs tracked by life science quality professionals

Documentation (read, signed, etc.)

74%​

Non-conformances (closure time, outstanding, etc.)

74%​

Training (completed, outstanding, etc.)

70%​

Suppliers (RPPM, SCARs)

54%​

Customer satisfaction (complaints, feedback, returns)

51%​

Defects/faults

30%​

Right-first-time %

23%​

Rework/first pass yield

20%​

Cost of poor quality (COPQ)

15%​

None

7%​

Other

4%​

Standards & audits

Learn how hundreds of life science quality professionals do their work, how they feel about management support, pay, resources and more. Understand the KPI metrics, quality standards, working styles and operational plans that will define 2022.

Number of standards/quality frameworks complied with:

3-5

46%

10+

25%

1-2+

19%

6-9

10%

Anticipated external audits in 2025:

1-5

82%

6-10

8%

0

5%

11-15

2%

21+

2%

16-20

1%

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