EXCEL SPREADSHEET REQUIREMENTS AND VALIDATION PROCESS
Under 21 CFR 11.10 Controls for closed systems, all spreadsheets that are used to facilitate the product and/or quality system decision-making processes need to be within compliance, including requirements for validation, accurate copies and protection of records, limited system access to authorized individuals, audit trails, authority, operational and device checks, training, electronic signatures, and change […]
President
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
