Sponsored content is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.

Sponsored Content

Audit Preparedness: Using Digital Validation to Be Ready for Anything
Joe Azzarella
Audit Preparedness: Using Digital Validation to Be Ready for Anything

When you’re in the pharmaceutical industry, you’re going to be audited — are you ready? Authored by Kneat’s audit expert, Joe Azzarella, Audit Preparedness: Using Digital Validation to Be Ready for Anything, explains what you should expect before, during, and after an inspection and what you can be doing to make sure you pass with flying colors.

Audits, inspections, and assessments — these regulatory activities may strike fear in the heart of many, but for seasoned validation professionals working in a highly regulated industry, they’re a fact of life.

Preparation is serious business. Failure to comply damages the relationship with regulatory bodies and can result in delays, warnings, fines, and in extreme cases, even jail time!

Read the eBook to Learn:

  • The differences between audits, inspections, and remote assessments. 
  • How to prepare your documents so you can easily respond to investigators. 
  • The challenges of being audit ready and how to overcome them. 
  • Why digital validation is your secret weapon in being ready for anything.
Audit Preparedness: Using Digital Validation to Be Ready for Anything

About Kneat

Kneat SolutionsKneat Solutions Ltd. (TSX: KSI) provides leading companies in highly regulated industries with unparalleled efficiency in validation and compliance through its digital validation platform Kneat Gx. We lead the industry in customer satisfaction with an unblemished record for retention and implementation, powered by our user-friendly design, expert support, and on-demand training academy.

Download Sponsored Content

To download this sponsored content, complete the form below. Once submitted, you will receive a link via the email you provided to download the sponsored content.

Company Type
  • United States+1
  • United Kingdom+44
  • Afghanistan (‫افغانستان‬‎)+93
  • Albania (Shqipëri)+355
  • Algeria (‫الجزائر‬‎)+213
  • American Samoa+1
  • Andorra+376
  • Angola+244
  • Anguilla+1
  • Antigua and Barbuda+1
  • Argentina+54
  • Armenia (Հայաստան)+374
  • Aruba+297
  • Ascension Island+247
  • Australia+61
  • Austria (Österreich)+43
  • Azerbaijan (Azərbaycan)+994
  • Bahamas+1
  • Bahrain (‫البحرين‬‎)+973
  • Bangladesh (বাংলাদেশ)+880
  • Barbados+1
  • Belarus (Беларусь)+375
  • Belgium (België)+32
  • Belize+501
  • Benin (Bénin)+229
  • Bermuda+1
  • Bhutan (འབྲུག)+975
  • Bolivia+591
  • Bosnia and Herzegovina (Босна и Херцеговина)+387
  • Botswana+267
  • Brazil (Brasil)+55
  • British Indian Ocean Territory+246
  • British Virgin Islands+1
  • Brunei+673
  • Bulgaria (България)+359
  • Burkina Faso+226
  • Burundi (Uburundi)+257
  • Cambodia (កម្ពុជា)+855
  • Cameroon (Cameroun)+237
  • Canada+1
  • Cape Verde (Kabu Verdi)+238
  • Caribbean Netherlands+599
  • Cayman Islands+1
  • Central African Republic (République centrafricaine)+236
  • Chad (Tchad)+235
  • Chile+56
  • China (中国)+86
  • Christmas Island+61
  • Cocos (Keeling) Islands+61
  • Colombia+57
  • Comoros (‫جزر القمر‬‎)+269
  • Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo)+243
  • Congo (Republic) (Congo-Brazzaville)+242
  • Cook Islands+682
  • Costa Rica+506
  • Côte d’Ivoire+225
  • Croatia (Hrvatska)+385
  • Cuba+53
  • Curaçao+599
  • Cyprus (Κύπρος)+357
  • Czech Republic (Česká republika)+420
  • Denmark (Danmark)+45
  • Djibouti+253
  • Dominica+1
  • Dominican Republic (República Dominicana)+1
  • Ecuador+593
  • Egypt (‫مصر‬‎)+20
  • El Salvador+503
  • Equatorial Guinea (Guinea Ecuatorial)+240
  • Eritrea+291
  • Estonia (Eesti)+372
  • Eswatini+268
  • Ethiopia+251
  • Falkland Islands (Islas Malvinas)+500
  • Faroe Islands (Føroyar)+298
  • Fiji+679
  • Finland (Suomi)+358
  • France+33
  • French Guiana (Guyane française)+594
  • French Polynesia (Polynésie française)+689
  • Gabon+241
  • Gambia+220
  • Georgia (საქართველო)+995
  • Germany (Deutschland)+49
  • Ghana (Gaana)+233
  • Gibraltar+350
  • Greece (Ελλάδα)+30
  • Greenland (Kalaallit Nunaat)+299
  • Grenada+1
  • Guadeloupe+590
  • Guam+1
  • Guatemala+502
  • Guernsey+44
  • Guinea (Guinée)+224
  • Guinea-Bissau (Guiné Bissau)+245
  • Guyana+592
  • Haiti+509
  • Honduras+504
  • Hong Kong (香港)+852
  • Hungary (Magyarország)+36
  • Iceland (Ísland)+354
  • India (भारत)+91
  • Indonesia+62
  • Iran (‫ایران‬‎)+98
  • Iraq (‫العراق‬‎)+964
  • Ireland+353
  • Isle of Man+44
  • Israel (‫ישראל‬‎)+972
  • Italy (Italia)+39
  • Jamaica+1
  • Japan (日本)+81
  • Jersey+44
  • Jordan (‫الأردن‬‎)+962
  • Kazakhstan (Казахстан)+7
  • Kenya+254
  • Kiribati+686
  • Kosovo+383
  • Kuwait (‫الكويت‬‎)+965
  • Kyrgyzstan (Кыргызстан)+996
  • Laos (ລາວ)+856
  • Latvia (Latvija)+371
  • Lebanon (‫لبنان‬‎)+961
  • Lesotho+266
  • Liberia+231
  • Libya (‫ليبيا‬‎)+218
  • Liechtenstein+423
  • Lithuania (Lietuva)+370
  • Luxembourg+352
  • Macau (澳門)+853
  • North Macedonia (Македонија)+389
  • Madagascar (Madagasikara)+261
  • Malawi+265
  • Malaysia+60
  • Maldives+960
  • Mali+223
  • Malta+356
  • Marshall Islands+692
  • Martinique+596
  • Mauritania (‫موريتانيا‬‎)+222
  • Mauritius (Moris)+230
  • Mayotte+262
  • Mexico (México)+52
  • Micronesia+691
  • Moldova (Republica Moldova)+373
  • Monaco+377
  • Mongolia (Монгол)+976
  • Montenegro (Crna Gora)+382
  • Montserrat+1
  • Morocco (‫المغرب‬‎)+212
  • Mozambique (Moçambique)+258
  • Myanmar (Burma) (မြန်မာ)+95
  • Namibia (Namibië)+264
  • Nauru+674
  • Nepal (नेपाल)+977
  • Netherlands (Nederland)+31
  • New Caledonia (Nouvelle-Calédonie)+687
  • New Zealand+64
  • Nicaragua+505
  • Niger (Nijar)+227
  • Nigeria+234
  • Niue+683
  • Norfolk Island+672
  • North Korea (조선 민주주의 인민 공화국)+850
  • Northern Mariana Islands+1
  • Norway (Norge)+47
  • Oman (‫عُمان‬‎)+968
  • Pakistan (‫پاکستان‬‎)+92
  • Palau+680
  • Palestine (‫فلسطين‬‎)+970
  • Panama (Panamá)+507
  • Papua New Guinea+675
  • Paraguay+595
  • Peru (Perú)+51
  • Philippines+63
  • Poland (Polska)+48
  • Portugal+351
  • Puerto Rico+1
  • Qatar (‫قطر‬‎)+974
  • Réunion (La Réunion)+262
  • Romania (România)+40
  • Russia (Россия)+7
  • Rwanda+250
  • Saint Barthélemy+590
  • Saint Helena+290
  • Saint Kitts and Nevis+1
  • Saint Lucia+1
  • Saint Martin (Saint-Martin (partie française))+590
  • Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon)+508
  • Saint Vincent and the Grenadines+1
  • Samoa+685
  • San Marino+378
  • São Tomé and Príncipe (São Tomé e Príncipe)+239
  • Saudi Arabia (‫المملكة العربية السعودية‬‎)+966
  • Senegal (Sénégal)+221
  • Serbia (Србија)+381
  • Seychelles+248
  • Sierra Leone+232
  • Singapore+65
  • Sint Maarten+1
  • Slovakia (Slovensko)+421
  • Slovenia (Slovenija)+386
  • Solomon Islands+677
  • Somalia (Soomaaliya)+252
  • South Africa+27
  • South Korea (대한민국)+82
  • South Sudan (‫جنوب السودان‬‎)+211
  • Spain (España)+34
  • Sri Lanka (ශ්‍රී ලංකාව)+94
  • Sudan (‫السودان‬‎)+249
  • Suriname+597
  • Svalbard and Jan Mayen+47
  • Sweden (Sverige)+46
  • Switzerland (Schweiz)+41
  • Syria (‫سوريا‬‎)+963
  • Taiwan (台灣)+886
  • Tajikistan+992
  • Tanzania+255
  • Thailand (ไทย)+66
  • Timor-Leste+670
  • Togo+228
  • Tokelau+690
  • Tonga+676
  • Trinidad and Tobago+1
  • Tunisia (‫تونس‬‎)+216
  • Turkey (Türkiye)+90
  • Turkmenistan+993
  • Turks and Caicos Islands+1
  • Tuvalu+688
  • U.S. Virgin Islands+1
  • Uganda+256
  • Ukraine (Україна)+380
  • United Arab Emirates (‫الإمارات العربية المتحدة‬‎)+971
  • United Kingdom+44
  • United States+1
  • Uruguay+598
  • Uzbekistan (Oʻzbekiston)+998
  • Vanuatu+678
  • Vatican City (Città del Vaticano)+39
  • Venezuela+58
  • Vietnam (Việt Nam)+84
  • Wallis and Futuna (Wallis-et-Futuna)+681
  • Western Sahara (‫الصحراء الغربية‬‎)+212
  • Yemen (‫اليمن‬‎)+967
  • Zambia+260
  • Zimbabwe+263
  • Åland Islands+358

By completing this form, you consent to have your information provided to the third-party sponsor of this content and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you . ISPE will store your information in a secure environment and may use your information to provide information about relevant products, services, and other opportunities which may be of interest to you. You may unsubscribe from these ISPE communications at any time. For more information or to unsubscribe, review our Privacy Policy or contact us at ask@ispe.org.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Quality
Validation

About the Author

Joe Azzarella
Senior Customer Success Engineer
Kneat Solutions
Joe Azzarella is a Six Sigma Black Belt with 10+ years’ experience in lyophilization development, technology transfer, and process development for pharma and life sciences...