From the client’s order to the signed report, every step traceable

For testing and calibration labs working under ISO/IEC 17025 —accredited or getting ready for accreditation—: food, environmental, microbiology, industrial testing, metrology and calibration labs, and quality departments that issue reports to internal or external clients. If today your orders live in a spreadsheet, your results in paper notebooks and your quality records in binders, and the assessor comes back every year, BioForging is for you. Without turning on the quality modules, it also works for a research lab that only needs a traceable notebook.

BioForging covers a good part of what those audits ask for: records with author and date, and full version history; protocols with an approval state and change control over approved ones — editing one means opening a window with a written justification, and if whoever asks for it does not have the authority to approve it, somebody else has to sign off; method validity and obsolescence, with validity dates, a periodic review interval, an Obsolete state that withdraws a method without deleting it — old experiments keep showing it — and a warning when a run is executing against a version the method has already superseded; the reagent lot, taken from the inventory and recorded on every consumption; an electronic signature with password re-authentication that seals the content with a hash, so an edit made outside the app gives itself away, plus a reviewer countersignature — never the author — when the lab turns it on; a hash-chained audit trail sealed with a key that does not live in the database, which you verify from inside the app and export as CSV together with the result of that verification —there is one key for the whole platform and the lab does not hold it, so that seal cannot be recomputed from outside—; the equipment register, with identification, service status and its log, calibrations with the reference standard, certificate number, reported uncertainty and the attached certificate, intermediate checks, and which instrument each experiment was run with — including whether it was calibrated on THAT day; nonconformities with their corrective actions: detection, impact assessment on work already reported — when an instrument is the one at fault, the system builds the list of experiments that used it inside the suspect window instead of leaving it to memory — containment, root cause, actions with an owner and a due date, and effectiveness verification by somebody other than whoever carried them out (if the lab has nobody else on hand you may close it yourself, but the record is flagged as not cross-checked); sample registration with chain of custody: when each sample arrived, in what condition and who received it, its aliquots, where it is and what work was done on it; validation and verification of each method, with its performance parameters and the statement of whether it is fit for the intended use; personnel competence: training, assessments and which methods each person is authorised for, with an expiry date and a warning before it lapses; test reports to clients, reviewed before issue by someone other than whoever issues them (if the lab has nobody else authorised to review, you may review it yourself, but the report says so), numbered, sealed and corrected through an amendment, never by editing the issued one; clients and test orders, with the review of the request before accepting it (§7.1) and the status of every job through to the report; measurement uncertainty computed per the GUM (JCGM 100:2008), on the test report —from the replicates and the uncertainty budget the lab declares: the system does the arithmetic, it does not choose the sources— and, for calibration labs, together with the calibration certificate; and the management system —on the web, in the desktop program and in the app—: control charts with ±2σ and ±3σ limits and Westgard rules over the results the notebook already measured, and proficiency tests and interlaboratory comparisons with their z-score (§7.7) — an out-of-control point or an unsatisfactory z opens an already linked nonconformity; the internal audit programme with its findings, which go to the nonconformity register (§8.8); the management review minutes, with the §8.9.2 inputs preloaded from what the system already knows, their decisions with owner and due date, and a seal on closing (§8.9); complaints as a process — receipt, acknowledgement, investigation, response and closure, with the response decided by someone other than whoever investigated (§7.9); the register of risks and opportunities with their assessment and actions (§8.5), and the register of external providers with their acceptance criteria, evaluation and re-evaluation (§6.6). Nonconformities, personnel competence, client reports, orders, calibrations, environmental conditions and the management system are turned on by each lab if it needs them, from Laboratory → Configure (the management system, from its own screen); client reports, orders, calibrations and the management system also require the Lab Quality plan, and nonconformities the Lab plan. It also keeps control of the management system documents (§8.3): the manual, procedures, work instructions, forms and external documents, with version, reason for change, approval with password by someone other than whoever wrote it (if nobody else is authorised, the author approves it and it is flagged), validity, periodic review and withdrawal as obsolete without deletion; and sampling plans (§7.3.1) as one more controlled document type, while each sample records who sampled it, how and where. Also: the formal correction of a signed experiment (§7.5.2), through an amendment signed with your password that points to the original without touching it or its seal, and that cannot be deleted; environmental conditions (§6.3) of each room or instrument against their limits, with a warning when a reading goes out of range or is overdue, and in every experiment whether the environment stayed in range between the record being opened and signed; delivery of the report to the client, with channel, recipient and acknowledgement of receipt; and PDF outputs to print and sign for the nonconformity, the management review minutes, the internal audit, the document master list and the control chart. For the use validation that is yours to do (§7.11.2) we give you the ELN validation package: the user requirements, the matrix that traces them to the automated tests run on every release —and says which ones are verified by hand—, OQ cases you can run yourself from the interface and, on request, the IQ/OQ report for the current release; ask support for it. What it does NOT cover today, and you have to solve elsewhere: the sampling plan is not a form with its own fields, it is a text document or a referenced file; and documents are recorded with their content or a reference to the file, without uploading the file itself. Important caveat: no software certifies a lab on its own, and BioForging is not a validated system and makes no claim of ISO 17025, 21 CFR Part 11 or GxP compliance: certification depends on your procedures and on the body auditing you.

The Free plan is US$ 0 forever (1 lab, 3 people including the lead, 25 experiments, 1 GB). The Lab plan is US$ 99 per month per lab —not per user— with 10 users included and 50 GB; Lab Quality is US$ 249 per month, with 20 users, 200 GB and support with a 1 business day response commitment. If your lab is in Argentina or Latin America, the regional price is US$ 79 and US$ 179 per month, and that discount applies to the whole invoice, additional users included. Paying yearly you pay for 10 months (11 at the regional price). Each user beyond the ones included costs US$ 8 per month, or US$ 6 at the regional price. If your lab needs more users than the Quality plan covers, or your company runs several labs, the Enterprise plan has no cap on users or storage and the price is agreed: write to us. What sets the plans apart is not only people and storage: test reports to clients (§7.8), clients and test orders, calibrations with certificate and the management system (control charts and proficiency testing, internal audits, management review, complaints, risks and suppliers) are enabled only on the Lab Quality plan (or Enterprise), and nonconformities from the Lab plan up. If the lab moves down a plan, what it already recorded in those modules can still be viewed and exported; what stops is creating or issuing new records. The external auditor is also part of Lab Quality and takes no seat: up to two at a time, each with an expiry date; they read experiments, methods, samples, equipment, reports and quality records and leave observations, but they cannot export, cannot run the audit-chain verification and do not see clients, quotes, orders or staff competence files. Onboarding —migrating your inventory, loading your protocols and training the team— is a one-time fee starting at US$ 600 depending on scope. Each lab can try the Lab Quality plan for free for 14 days, once (and once per account): whoever manages the lab turns it on from Settings, on the web, and when it ends the lab goes back to Free without losing anything it recorded.