ISO 17025 accredited systems
Testing operates inside an accredited laboratory quality framework rather than informal internal habits.
ISO 17025 Accredited
Documented controls for auditable laboratory work
ISO 17025 • ALCOA+ • Independent QC Review
Quality systems built for regulatory review, traceable records, and defensible data.
BioChroma operates under ISO 17025 accredited systems with cGMP conditions, ALCOA+ data integrity practices, independent QC review, and documented controls designed to support chemistry, microbiology, molecular biology, and stability programs.
ALCOA+ data integrity
Records are expected to remain attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Independent QC review
Analytical datasets undergo independent quality review before release.
Compendial and cGMP alignment
Methods and operating conditions are selected with reference to USP, EP, AOAC, FDA BAM, USDA, cGMP, and ICH expectations where applicable.
BioChroma’s quality framework is designed for teams that need more than a marketing promise. The laboratory operates under ISO 17025 accredited systems, applies ALCOA+ data integrity practices, uses document control in BCAL-CO-XXXXXX format, and reviews analytical datasets through independent QC before release. The page is intentionally written like a quality manual summary so QA, regulatory, and technical reviewers can scan the controls, records language, and standards alignment without digging through marketing claims.
Quality Architecture
The quality system is built on document control, CAPA, internal audit, and independent data review.
01
Document control
Controlled documents use the BCAL-CO-XXXXXX format so records can be identified, revision-managed, and reviewed without ambiguity.
02
CAPA
Corrective and preventive action processes give the quality group a structured path for documenting, investigating, and following through on issues.
03
Internal audit
Internal audits check whether procedures and quality expectations are being maintained across departments over time.
04
Data review
Independent QC review helps confirm that the dataset and supporting record are ready for release and external review.
ALCOA+ Data Integrity
Each record is expected to stay attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Attributable
Each record should be tied to the person who created or reviewed it.
Legible
The record should remain readable and understandable throughout its useful life.
Contemporaneous
Data should be recorded at the time the work is performed, not reconstructed later.
Original
The retained record should preserve the original observation, source, or first capture of the data.
Accurate
The record should reflect the work truthfully and without unexplained alteration.
Complete
The dataset should include the full supporting record needed for review, not just the favorable result.
Consistent
Records should follow a coherent sequence so reviewers can understand what happened and when.
Enduring
Data should remain preserved in a durable form that supports later review.
Available
Records should be retrievable when QA, regulatory, or technical review requires them.
Regulatory Standards
BioChroma describes quality work in the same framework language that QA, regulatory, and technical reviewers already use.
USP
Compendial chemistry and microbiology references used where applicable to the method or test.
EP
European pharmacopeial references used where the product program or method context calls for them.
AOAC
Recognized analytical methods used when the matrix and decision context fit AOAC-aligned workflows.
FDA BAM
Reference framework for microbiology and food-related methods where appropriate.
USDA
Applicable compendial references for food and agriculture-related testing programs.
ICH
Guidance framework for stability study planning, condition selection, and trend review.
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