Pharmaceutical document review
Start with the evidence

Start with one study and agree what reviewers need to receive: an evidence table, a discrepancy list and a draft section. Matrix can be configured to find evidence, compare approved results and draft from agreed templates. The task is to organize existing records, not supply absent observations or scientific conclusions. Set the source list and output boundaries before work begins.

Use authorized exports from your document repository, electronic laboratory notebook (ELN), laboratory information management system (LIMS) or instrument software. Agree formats, versions and the data dictionary during scoping. Accepting exports does not establish direct system access: native connectors, write-back and production integration are separate deliverables.

• List approved protocol and report versions, authorized exports and the review period. Name who confirms the set is sufficient for the task; record excluded sources and reasons.
• Specify the evidence table, discrepancy list and draft section separately. Keep factual extracts apart from reviewer comments; mark unresolved observations wherever they appear in the draft.
• Confirm which repository or research-system exports the team can authorize and who produces them. Record required fields and file formats; do not assume direct system access.

The same number can belong to a different sample, lot or time-point. Open the cited source and read its headings, footnotes and method context. Keep qualifiers attached to the observation. Missing identifiers, unreadable files, conflicting results and uncertain units belong in the review pack, not behind a polished sentence. Do not infer missing observations, silently select a preferred result or guess conversions. Reviewer corrections must leave the original sources intact.

• Record the file, version and page or source row for each extracted observation. Open that location and read surrounding headings, footnotes or narrative before accepting the entry.
• Check units and applicable sample, lot and time-point identifiers against the source. Retain method context; flag missing identifiers rather than matching records by position.
• Hold entries with missing or ambiguous units for a named reviewer. Preserve original values and labels; convert only under a rule the team has specified and approved.
• Show conflicting approved results side by side with source references and versions. Keep missing observations and unreadable files visible; assign discrepancies instead of selecting a preferred value.

Your team controls file permissions and every administrator account. In ordinary setup and support, Synexas neither views nor receives working data and retains no administrator account; the optional-proof exception is defined below. Maintenance is by invitation on site, with access your team grants and removes. Qualified scientific and quality reviewers own interpretation, investigations, approvals and product-release decisions. Matrix is offline by default. IT may approve agents reaching outside services, usually to read and, where the task requires it, to send. Requests carry what the agent sends. Matrix accepts no requests from outside the company.

• Name qualified scientific and quality reviewers for evidence checks, discrepancy resolution and draft approval. Exclude clinical, method, batch-release and formulation recommendations; route decision requests to the responsible team.
• Have administrators test approved accounts with different permissions. Check local audit-log exports against agreed events and retention requirements; do not assume all required evidence is recorded.
• Review accounts and invited on-site maintenance records, including access removal. For each approved outside service, document what the agent sends and the IT approval covering the connection.
• For an optional custom-workflow proof, authorize data under an NDA. Confidential data may be approved; personal data requires a lawful basis you confirm. Choose your site on a Matrix Synexas brings or Synexas's own offline environment. Confirm deletion afterwards. This is the sole exception to Synexas not viewing or receiving working data.

Agree blocking failures, exception owners and correction checks in advance. Reviewers must reconcile the pack to original records and confirm that unresolved items remain explicit in the draft. A complete-looking document is not acceptance evidence. To request a demo, describe the task only; never send working data through the website.

• Include absent observations, a missing source page and an unreadable file. Each must remain visible with its source reference and owner, without becoming an unsupported result in the draft.
• Include contradictory approved records and ambiguous units. Require both conflicting values and their context, no unsupported conversions, and an identified reviewer responsible for resolution.
• Reconcile expected source files and rows to the evidence table; record exclusions. Check values, units and identifiers against originals, then trace factual draft statements to accepted source entries.
• Log corrections with the affected source version and output location. Repeat relevant checks after changes and record unresolved exceptions. A cleaner draft does not prove a discrepancy was resolved.