Life science quality
trends report 2024

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

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What stood out…

42% still using paper

Almost half of life science quality professionals still rely on analog quality systems

Quality getting harder each year

Weak quality cultures and compounding regulatory requirements are making the job more difficult

Money where the mouth is?

Business leaders promote quality - but don't invest in it to the same degree

Time spent in the wrong places

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

Less investment = less maturity

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

Key 2024 objective: process improvements

And almost half of respondents are aiming to bring a new product to market this year!

What stood out…

42% still using paper

Almost half of life science quality professionals still rely on analog quality systems

Quality getting harder each year

Weak quality cultures and compounding regulatory requirements are making the job more difficult

Money where the mouth is?

Business leaders promote quality - but don't invest in it to the same degree

Time spent in the wrong places

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

Less investment = less maturity

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

Key 2024 objective: process improvements

And almost half of respondents are aiming to bring a new product to market this year!

What stood out…

42% still using paper

Almost half of life science quality professionals still rely on analog quality systems

Quality getting harder each year

Weak quality cultures and compounding regulatory requirements are making the job more difficult

Money where the mouth is?

Business leaders promote quality - but don't invest in it to the same degree

Time spent in the wrong places

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

Less investment = less maturity

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

Key 2024 objective: process improvements

And almost half of respondents are aiming to bring a new product to market this year!

Quality & compliance targets for 2024

38% of medical device companies aim to achieve EU MDR or IVDR compliance in 2024.

Over a third of pharma and biotech companies have no new plans.

EU MDR/IVDR

38%

ISO 13485

30%

FDA 21 CFR 820

27%

None

24%

ISO 14971

22%

GMP

11%

None

36%​

ISO 9001

21%​

FDA QMM* program

16%

GMP

14%​

PIC/S

12%​

ICH Q guidelines

5%

Medical device

Therapeutics

*Quality Management Maturity

Medical device

Therapeutics

*Quality Management Maturity

Impact of an eQMS

Going digital pays off

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

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

9%

No

91%

Yes

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

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

18%

No

82%

Yes

Stats and metrics

Most common KPIs tracked by life science quality professionals

Training (completed, outstanding, etc.)

71.6%​

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

68.4%​

Documentation (read, signed, etc.)

67.4%​

Customer satisfaction (complaints, feedback, returns)

50.5%​

Suppliers (RPPM, SCARs)

50.5%​

Defects/faults

32.6%​

Rework/first pass yield

22.1%​

Right-first-time %

22.1%​

Cost of poor quality (COPQ)

21.1%​

None

4.2%​

Other

4.2%​

Headcount

Headcount

Headcount

How teams are structured

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.

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.

“How many people work in your organization?”

“How many people work in your organization?”

“How many people work in your organization?”

1-10

13.7%

11-50

24.2%

51-200

29.5%

201-500

17.9%

500+

14.7%

“How many people work in your organization’s quality department?”

“How many people work in your organization’s quality department?”

“How many people work in your organization’s quality department?”

1-10

13.7%

11-50

24.2%

51-200

29.5%

201-500

17.9%

500+

14.7%

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See the full report now

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See the full report now

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