Documentation
Documentation is not paperwork, it’s the mechanism that turns scientific intent into operational control and it’s the evidence that proves your work is compliant, repeatable, and trustworthy. Whether you operate under GMP, GLP, ISO 13485, 17025, 9001 or internal quality standards, strong documentation reduces risk, shortens timelines, and builds confidence with auditors, clients, partners, and regulators.
High-performing teams don’t document more, they document better. The right documentation system makes it easy to do the right thing: clear SOPs that match reality, templates that guide consistent decisions, records that are complete and traceable, and a document control process that supports change without chaos. Terraforme Biosciences helps life sciences organizations build documentation that is practical, adoptable, and inspection-ready.
Documentation We Support
Common deliverables include SOPs and work instructions, controlled forms and logbooks, batch records (as applicable), validation documentation (URS/FDS/IQ/OQ/PQ), training materials, quality plans, technical reports, deviation/CAPA records, change controls, supplier qualification packages, and audit-ready evidence bundles.
problems we solve
Data Integrity
In regulated life sciences, the question is not only “Did you do the work?” it’s “Can you prove the data is complete, accurate, and trustworthy?” Data integrity issues often arise quietly: uncontrolled spreadsheets, shared logins, missing audit trails, back-dated entries, ambiguous corrections, or records that don’t clearly show who did what and when. Even when the underlying science is strong, weak data practices can undermine the credibility of results, trigger audit findings, and create serious risk during product release, client disputes, or regulatory inspections.
We help organizations build practical data integrity controls that match how work actually happens. That includes strengthening good documentation practices (GDP), improving record completion expectations, defining clear correction practices, and building traceability between raw data, calculations, reviews, and final reports. Where systems allow, we help configure access controls, audit trail review routines, and review-by-exception workflows—so data integrity becomes an operational habit, not an audit scramble.
Documentation In The Era Of Computerized Systems
Modern life sciences operations rely on computerized systems: LIMS, eQMS, ERP, MES, chromatography data systems, instrument software, cloud platforms, and collaborative tools. The challenge is that digital workflows can create new failure modes: unclear system ownership, poor permission design, inconsistent metadata, uncontrolled exports to spreadsheets, mismatched “system of record” decisions, lack of audit trails, and documentation that lives across too many tools to be traceable. When audits happen, teams struggle to demonstrate control across both paper and digital records.
We help you modernize documentation so it remains clear, controlled, and defensible in mixed paper–digital environments. That includes defining your document and data architecture (what lives where, and why), tightening templates and controlled records for digital workflows, and building SOPs that explicitly address electronic signatures, audit trails, access, backups, and retention. We also support practical validation-ready documentation (URS and traceability) for computerized systems so you can scale technology without losing compliance, retrievability, or confidence.
our approach
Clarity first: Plain-language documentation that is usable on the floor and defensible in audits.
Structure that scales: A document hierarchy and template set that stays consistent as you grow.
Execution-aligned: Procedures and records built around real workflows, not idealized org charts.
Audit-ready evidence: Faster retrieval, cleaner traceability, and fewer documentation-based findings.
Sustainable ownership: Tools, style guides, and coaching so your team can maintain the system long-term.
FAQs
Why is documentation so important in GMP and regulated life sciences?
Documentation is the evidence of control. It shows that work was performed consistently, deviations were handled appropriately, and decisions were traceable and justified, especially under audit or inspection.
What’s the difference between SOPs, work instructions, and forms?
SOPs define the process and responsibilities at a higher level. Work instructions provide step-by-step execution detail. Forms and records capture evidence that the process was followed and results met acceptance criteria.
What are common documentation issues that lead to audit findings?
Typical issues include outdated versions in use, missing approvals, unclear training linkage, inconsistent records, vague acceptance criteria, uncontrolled templates, and procedures that don’t match actual practice.
Can you help us write SOPs from scratch?
Yes. We can build SOPs, templates, and a document hierarchy from the ground up, or modernize an existing system depending on your stage, risk profile, and regulatory context.
How do you make SOPs usable for real teams?
We focus on clarity, role-specific responsibilities, realistic workflows, and simple supporting tools (forms, checklists, decision trees). The goal is to make the controlled process the easiest way to work
Do you support document control system setup or cleanup?
Yes. We can design document control rules and workflows, standardize naming/indexing, and organize controlled libraries so retrieval is fast and version control is reliable.
How does documentation support due diligence or partnerships?
Strong documentation reduces uncertainty. It helps buyers and partners quickly verify compliance, traceability, validation rationale, and operational maturity, often speeding diligence and improving confidence in the asset.
What does “audit-ready documentation” mean?
It means you can quickly produce the right evidence: current approved procedures, trained personnel, complete records, traceable decisions, and a consistent story that matches how the operation truly runs.
Turn Documentation Into Your Competitive Advantage
Strong documentation reduces risk, speeds timelines, and builds trust with regulators and partners. Reach out today to learn how we can support your compliance goals.
Terraforme Biosciences 