Every bench on the current procedure, approved and on record.

For clinical, testing and research laboratories that answer to CLIA, ISO/IEC 17025 assessors and FDA GLP inspectors. Procedures approved, sent to the people who run them, and on record by person and by version.

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A laboratory bench with two incubators, tube racks, instruments and a microscope under a shelf of media bottles.

Ready for every assessment

Good laboratories already have the procedures. The work is keeping every approval, every version and every acknowledgment as ready as the results.

42 CFR 493.1251

CLIA procedure manual

Procedures and every change to them approved, signed and dated by the current director before use, with each procedure’s dates of use kept.

  • The director as approver on every procedure and change, logged with the date
  • Every version kept with its dates
  • Each person’s acknowledgment of the current version

ISO/IEC 17025, clauses 8.2 to 8.4, 6.2

ISO/IEC 17025 document control

Management system documents controlled, records kept and personnel competence on file, with the technical work behind them.

  • Documents approved, versioned and reviewed
  • Competence records attached as evidence
  • Only the current version in use

21 CFR 58.81

GLP standard operating procedures

Written SOPs for study methods, and significant changes authorised in writing by management.

  • Each SOP and change approved by management
  • Every version kept for the study record
  • The study team on the current version

29 CFR 1910.1450

OSHA laboratory standard

A written chemical hygiene plan, reviewed for effectiveness at least once a year, with every lab worker informed.

  • The yearly review on a review date
  • Each revision sent to every bench
  • Every version kept

How it helps a laboratory

Built for quality managers who show document control to surveyors, assessors and sponsors.

The right procedure at the bench

Each section sees its current procedures only. Earlier versions stay in history.

New hires covered from day one

Invite a new technologist with their tags and their procedures are waiting.

No seat cost for staff

Technologists and other viewers are unlimited and free. You pay for the people who write.

Director approval built in

Set the director as approver, and every procedure and change waits for them.

Every change goes out again

A revised procedure is approved, then everyone it covers is asked again, automatically.

Proof on request

Filter the record by date, person or procedure and export a PDF or CSV.

Each bench gets its own procedures

Tag people by section and role. Each procedure reaches only the people who run it, and new hires get theirs on day one.

A record for every technologist

Show an assessor who has acknowledged which version, with the time and the statement they agreed to.

The rest of the binder

Assessment standards cover part of it. A laboratory runs on many other policies, and they need the same control.

Bloodborne pathogens

The exposure control plan reviewed every year and sent to every role with exposure.

Calibration and equipment

Procedures versioned, with calibration certificates attached as evidence.

Proficiency testing

The procedure current, with results attached as the lab’s records.

Specimen and sample handling

Acceptance and rejection criteria current at every bench.

Hazard communication

Safety data and labelling rules in one current program.

Handbook and confidentiality

One current version for scientists and staff, confirmed when it changes.

Ready for whoever asks.

CLIA surveyors, accreditation assessors and FDA inspectors ask the same thing in different words: the current procedure, who approved it and who runs it.

Export the record as a PDF or CSV, or let an assessor open the document directly.

  • CLIA surveyorsDirector-approved procedures with their dates of use
  • ISO/IEC 17025 assessorsControlled documents and competence records
  • FDA GLP inspectorsSOPs and every authorised change
  • Clients and sponsorsYour quality procedures, approved and current

Built around your laboratory

Sections and rolesTags such as Chemistry, Microbiology or Study team send each procedure only to the people who run it.
Your directorSet the laboratory director as approver on every procedure.
ConsultantsBring in your quality consultant as an external user to write and review.
AssessorsGive an assessor one document with a one-time code.

Need help writing the policies? Find a consultant for your standard.

Questions

Do technologists and staff need a paid seat?

No. They read, acknowledge and sign as viewers, free of charge.

Acknowledgment or signature?

Both are available. Choose for each policy when you send it. e-sign is an add-on on the Scale plan.

What happens when a policy changes?

The new version is approved, then sent to everyone it applies to, who are asked again.

Can an auditor see a document without an account?

Yes. Add them as a one-time viewer and they open that document with a one-time code.

Can the laboratory director approve every procedure?

Yes. Add the director as an approver. Each approval is logged with the person and the time.

What happens to someone’s record when they leave?

Their completed acknowledgments stay on record.

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