Audit-trail review
See who changed what, when it changed, what it affected, and what happened next.
Regulated life sciences
Your QC and QA work is growing faster than your team.
If you're heading toward GMP readiness, moving a method or process into regulated manufacturing, running your first regulated batches or tests, or juggling outsourced testing across partners, we help you keep the quality work connected as it grows.
Who this is for
Built for the moment QC operations start to strain.
Most teams reach for PixeSciTM at a specific trigger point, not on a generic timeline: preparing for a GMP inspection, transferring a method or process from R&D into regulated manufacturing, standing up QC for the first time, or watching investigation and reconciliation time climb as volume grows.
- GMP readiness and first regulated manufacturing or testing runs
- Technology transfer from R&D into a regulated process
- Rising QC volume outpacing manual reconciliation and review
- Fragmented, outsourced, or multi-vendor testing that's hard to reconcile
Keep one record across every tool.
Results move between instruments, analysis tools, spreadsheets, LIMS or ELN systems, and reviewers. Connect those steps and keep the files, settings, owners, results, and approvals together.
- Balance or pH meter → LIMS → batch record
- Chromeleon or Empower → LIMS → batch record
- Environmental monitor → excursion check → deviation in your QMS
- Contract lab report → intake → review → record
- Lab results and CoAs → PixeSciTM TM Laboratory and Quality Management records
- Every handoff above watched continuously by PixeSciTM's Continuous Quality Monitoring
You said: Review today's HPLC results and prepare the record.
PreviewConsoleIDENotes
plate-7-review7 variablesconnected
Instrument output
source / sample-set-042
Data check
action / validate-results
Calculation
parameters / calc-v3
review
Review checkpoint
operator / required
queued
LIMS / ELN record
file / approved
05
steps
12
events
03
files
Run records
Review errors, changes, and reruns faster.
Keep source files, settings, operator actions, results, and reasons for change with each run. Reviewers can see what happened without searching through separate logs and notes.
When a deviation, exception, or rerun occurs, teams can inspect the full history and use it in their existing quality process. These investigations are also where PixeSciTM's compliance agents flag gaps before release, not just after.
You asked: Who changed this result, and when?
12
events
00
failed
01
review
12
tamper
09:42:16
Workflow execution started
workflowinfowf-flow-review-042
09:43:08
Analysis parameters applied
datainfoanalysis-v3.json
09:44:51
Output checksum recorded
compliancesuccesssha256: 8c7a…9f2e
09:46:03Latest event
Operator review requested
compliancewarningreview / qc-director
Record detail
- Actor
- A. Mensah
- Role
- researcher
- Category
- workflow
- Severity
- info
- Review
- required
- Tamper evident
- yes
- Change reason
- parameter set approved
- Event ID
- evt_01J8QF
Customer review rules determine the final decision.
OOS and OOR records
Keep original results, run details, settings, change reasons, and reviews for an investigation — and block release automatically until it closes.
Change control
Track approved changes to workflows, versions, and settings.
Controlled deployment
Keep software, data, and records under your control.
PixeSciTM runs on a PixeSciTM Node installed at your site. Work stays close to your apps, instruments, files, and approved data stores.
Keep workflows within your network, access rules, and backup process. You do not need a cloud service to run the work.
You asked: Does any of our data leave the site?
Data location
Approved local folders
Public internet
Blocked
Controlled actions
Approval required
Credentials
Stored locally
Run records
Audit logging on
Backup policy
Customer managed
Before a run starts
3 / 3 checkedSoftware access follows approved policy
High-risk steps pause for a person
Run records stay with the workflow
Local data paths
Run workflows with approved folders and locally installed scientific apps.
Review checkpoints
Pause high-risk steps until a person approves them.
Validation boundary
Validate each configured workflow under your own quality system.